Dermatological Nursing Volume 20 Issue 2

The journal of the British Dermatological Nursing Group

Dermatological Nursing June 2021 Vol 20 Issue 2

Editorial

Now is the time to start taking NMSC more seriously Emergency Steroid Cards and guidance for dermatology nurses

HISTORICAL FOCUS

Para-medical skin camouflage is for everyone

CLINICAL PRACTICE

What is the evidence base to support the nurse specialist when counselling adult patients considering a systemic treatment for atopic eczema?

PRODUCT FOCUS

Fludroxycortide Tape: A versatile, well-tolerated treatment option

RESEARCH STUDY

Cultural nuances of skin shame: A qualitative study of skin conditions in Chinese women living in the UK

PHARMACOLOGICAL OPINION PROFESSIONAL DEVELOPMENT RESEARCH SKILLS ASK THE PHARMACIST PATIENT VOICE News & Views

THE BDNG WOULD LIKE TO THANK

Clascoterone: A novel, first-in-class topical anti-androgen treatment for acne Developing Patient Initiated Follow Up (PIFU) for people with skin conditions: An opportunity to ensure timely personalised access to follow-up care What are quantitative and qualitative research methods?

A brief introduction How does crystacide under duoderm work for molluscum contagiosum?

Ichthyosis during a pandemic • • • •

UK Dermatology Clinical Trials Network (UK DCTN) update Taking the BDNG into the world of podcasts Ann Davies, BDNG President 2012-13, retires Looking to the future

FOR SPONSORING OUR MEMBERS JOURNAL

The sponsorship covers the cost of production and distribution of this journal. The sponsorship includes advertising space in the journal.

AbbVie has no involvement in the journal’s editorial content.

Established by the BDNG in 1997 www.bdng.org.uk

REACH FOR

SKYRIZI

®

(risankizumab)

DURABILITY

85% of patients achieved PASI 90 through to 3.3 years *1

SIMPLICITY

Every 12 week maintenance dosing after initial starter dosing 2

SAFETY PROFILE

Consistent safety profile through to 4 years †1

SKYRIZI® (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.2 * Data from LIMMitless; an ongoing phase 3, single-arm, multicentre, international, open-label extension in which all patients receive SKYRIZI (150 mg) every 12 weeks. The 172 week analysis included patients who were initially randomized to receive SKYRIZI (150 mg) in 1 of 5 base phase II/III studies.

Results from 172 week interim analysis including integrated data from five phase 2/3 studies (UltIMMA-1, UltIMMa-2, SustaIMM, IMMvent, and NCT03255382)2-5 and the LIMMitless study. Efficacy was assessed every 12 weeks by PASI 90, PASI 100, sPGA 0/1, mean PASI percent improvement. Quality of life was assessed every 24 weeks by DLQI 0/1. LOCF (last observation carried forward): used completed evaluation from the most recent visit to impute missing data at later visits. PASI 90 = 90% improvement in Psoriasis Area and Severity Index. † Long term safety included patients in LIMMitless who were initially randomized to receive SKYRIZI (150 mg) in 1 of 5 base Phase II/III studies (patients with continuous SKYRIZI use). The 208 week interim analysis includes integrated data from the five Phase 2/3 studies (UltIMMA-1, UltIMMa-2, SustaIMM, IMMvent, and NCT03255382) and the LIMMitless study.

PRESCRIBING INFORMATION (PI) SKYRIZI™(risankizumab) 75 mg solution for injection in pre-filled syringe Refer to Summary of Product Characteristics (SmPC) for full information before prescribing.

PRESENTATION: Each pre-filled syringe contains 75 mg risankizumab in 0.83 ml solution.

INDICATION: For treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

DOSAGE AND ADMINISTRATION: Intended for use under guidance and supervision of a physician experienced in diagnosis and treatment of psoriasis. Dosage: The recommended dose of Skyrizi is 150 mg (two 75 mg injections) by subcutaneous injection at weeks 0, 4, and every 12 weeks thereafter. Consider discontinuation of treatment in patients showing no response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. Special Populations: Elderly: No dose adjustment required. Renal or hepatic impairment: No dose adjustment required. Paediatric Population: No data available.

CONTRAINDICATIONS: Hypersensitivity to any of the active substances or excipients. Clinically important active infections.

SPECIAL WARNINGS AND PRECAUTIONS: See SmPC for full details. Skyrizi may increase the risk of infections. In patients with a chronic infection or history of recurrent infections, or known risk factors for infection, Skyrizi should be used with caution. Treatment with Skyrizi should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients should be evaluated for tuberculosis infection prior to initiating treatment. Anti-TB therapy should be considered prior to initiating Skyrizi in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Completion of all appropriate immunisations should be considered prior to initiating therapy. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with Skyrizi.

Patients treated with Skyrizi should not receive live vaccines during treatment and for at least 21 weeks after treatment. Skyrizi contains 68.0 mg sorbitol and less than 1 mmol sodium (23 mg) per 150 mg dose.

INTERACTIONS: The safety and efficacy of Skyrizi in combination with immunosuppressants, including biologics or phototherapy have not been evaluated.

PREGNANCY AND LACTATION: Women of Childbearing potential: An effective method of contraception during treatment and for at least 21 weeks after treatment should be used. Pregnancy: Limited data available. It is preferable to avoid the use of Skyrizi during pregnancy as a precautionary measure. Lactation: It is not known whether Skyrizi is excreted in breast milk. Skyrizi may be used during breast-feeding if clinically needed. Fertility: The effect of Skyrizi on human fertility has not been evaluated.

ADVERSE REACTIONS: See SmPC for full details on adverse reactions. Very common adverse reactions (≥1/10): Upper respiratory infections. Common adverse reactions (≥1/100 to <1/10): Tinea infections, headache, pruritus, fatigue and injection site reactions.

LEGAL CLASSIFICATION: POM MARKETING AUTHORISATION NUMBERS/PRESENTATIONS/NHS LIST PRICE: EU/1/19/1361/001: Skyrizi 75 mg solution for injection in pre-filled syringe (Pack of 2 pre-filled syringes): £3326.09 LOCAL REPRESENTATIVE: AbbVie Ltd, Maidenhead, SL6 4UB DATE OF REVISION: April 2019 PI-Skyrizi-001

Adverse events should be reported. Reporting forms and information can be found at: https://yellowcard.mhra.gov.uk.

Adverse events should also be reported to AbbVie on GBPV@abbvie.com

References: 1. Papp K, et al. Poster 1366, presented at European Academy of Dermatology and Venereology (EADV) Congress, October 2020. 2. SKYRIZI Summary of Product Characteristics.

UK-RISN-210040 Date of preparation: February 2021

Dermatological Nursing Note to members: The sponsorship funding goes directly towards the print, post and distribution costs associated with providing your journal and has no involvement in deciding or influencing any editorial content. The sponsorship includes advertising space within the journal. The BDNG would like to thank for their sponsorship and support in helping bring our members this vital membership benefit

EDITORIAL Now is the time to start taking NMSC more seriously

6

Anju Bhalla

8

Emergency Steroid Cards and guidance for dermatology nurses Polly Buchanan

HISTORICAL FOCUS Para-medical skin camouflage is for everyone

10

Elizabeth Allen

CLINICAL PRACTICE What is the evidence base to support the nurse specialist when counselling adult patients considering a systemic treatment for atopic eczema?

15

Laura Crosby

PRODUCT FOCUS Fludroxycortide Tape: A versatile, well-tolerated treatment option

23

Sara Burr

RESEARCH STUDY Cultural nuances of skin shame: A qualitative study of skin conditions in Chinese women living in the UK

29

Erica Lam, Andrew Thompson

PHARMACOLOGICAL OPINION Clascoterone: A novel, first-in-class topical anti-androgen treatment for acne

36

Rod Tucker

PROFESSIONAL DEVELOPMENT Developing Patient Initiated Follow Up (PIFU) for people with skin conditions: An opportunity to ensure timely personalised access to follow-up care

40

Julia K Schofield, Jenny Wood

RESEARCH SKILLS What are quantitative and qualitative research methods? A brief introduction

45

Joanne Chalmers, Fiona Cowdell

ASK THE PHARMACIST How does crystacide under duoderm work for molluscum contagiosum?

51

Rod Tucker

PATIENT VOICE Ichthyosis during a pandemic

Sponsored by

|

55

Sponsored by

|

58

Amy Probert

PODCAST Taking the BDNG into the world of podcasts BDNG NEWS UK Dermatology Clinical Trials Network (UK DCTN) update

Ann Davies, BDNG President 2012-13, retires Looking to the future www.bdng.org.uk

59 Sponsored by

|

63 66

Dermatological Nursing, 2021, Vol 20, No 2

3

The journal of the British Dermatological Nursing Group

Dermatological Nursing Editorial staff

Editorial board

Kathy Radley

Mandy Aldwin/Sarah Griffiths-Little

Michelle Ogundibo

Chair of the Editorial Board, Senior Lecturer, School of Life and Medical Sciences, University of Hertfordshire, and Dermatology Nurse Specialist, East & North Hertfordshire NHS Trust

Ichthyosis Support Group

Paediatric Dermatology Nurse Specialist, Chapel Allerton Hospital (Leeds Teaching Hospitals Trust)

Polly Buchanan

Podiatrist and Associate Professor, Southampton

Clinical Editor Community Dermatology Nurse Practitioner, NHS Fife dneditor@bdng.org.uk pbuchanan1@nhs.net

Rob Mair

Fiona Cowdell

Jean Robinson

Professor of Nursing and Health Research, Faculty of Health, Education and Life Sciences, Birmingham City University

Clinical Nurse Specialist Paediatric Dermatology, Royal London Hospital, Barts Health NHS Trust, London

Karen Stephen

Steven Ersser

Lead Dermatology Nurse, NHS Tayside

Managing Editor Rob.Mair@pavpub.com

Tony Pitt Art Director Tony.Pitt@pavpub.com

Advertising Mark Freeman Advertising & sponsorship dnadvertising@bdng.org.uk 07957 404 831

Julie Brackenbury Aesthetic Nurse Specialist, JB Cosmetic, Bath

Rebecca Penzer-Hick

Ivan Bristow Sara Burr

Senior Lecturer, Postgraduate Medicine, University of Hertfordshire & Dermatology Specialist Nurse, Dermatology Clinic Community Services, Cambridgeshire

Community Dermatology Specialist Nurse/Clinical Lead Community Skin Integrity Team, Norfolk Community Health and Care NHS Trust

Nurse Consultant Skin Cancer & Dermatology, Kingston Hospital NHS Foundation Trust

Professor of Nursing & Dermatology Care & Head of Department of Nursing Science, Bournemouth University

Saskia Reeken

Jackie Tomlinson

Tanya Flavell

Dermatology Clinical Nurse Specialist, Addenbrooke’s Hospital, Cambridge University Hospitals Foundation Trust

Advanced Nurse practitioner in Dermatology, Withington Community Hospital, Manchester University Hospitals NHS Trust

Rod Tucker Community Pharmacist/Researcher with a Special Interest in Dermatology, East Yorkshire

Mark Goodfield

Andrew Thompson

Consultant Dermatologist, Leeds Teaching Hospitals NHS Trust

Clinical Health Psychologist & Reader in Clinical Psychology, University of Sheffield

Karina Jackson

Julia Wheeler

Nurse Consultant, St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust, London

Dermatology Outreach Nurse, Buckinghamshire NHS Trust, Education Development Nurse, BDNG

Ibrahim Nasr

Carrie Wingfield

Retired Consultant Dermatologist, Gloucester

Dermatology Nurse Consultant, Norfolk and Norwich University Hospital

bdng Dermatological Nursing is the official journal of the BDNG. To contact the BDNG, email: admin@bdng.org.uk or tel: 028 905 11402 Printed in Great Britain by Gemini Print, Dolphin Way, Shoreham-by-Sea, West Sussex BN43 6NZ The BDNG logo and name are Registered Trademarks.

All registered rights apply.

4

Dermatological Nursing (ISSN 1477-3368) is published by the BDNG, Forsyth House, Cromac Square, Belfast, BT2 8LA. Tel: 028 905 11402, www.bdng.org.uk All rights reserved. No part of this publication may be reproduced, stored or transmitted in any form or by any means without the prior written permission of the BDNG. Opinions expressed in articles are those of the authors and do not necessarily reflect those of the BDNG or the editorial/advisory board. Advertisements have no influence on editorial content or presentation.

Dermatological Nursing, 2021, Vol 20, No 2

www.bdng.org.uk

Proven, preferred & effective twice daily emollient

Doublebase DAYLEVE Gel Isopropyl myristate 15% w/w, liquid paraffin 15% w/w

D O U BL E B A

SE Doublebase DAYLEVE Gel has been shown DAYLEVE GEL to exhibit significantly superior hydration EVIDENCE BAS compared to another prescribed emollient E cream (ZBC†), when applied twice daily in subjects with atopic eczema.2 In this double-blind, bi-lateral comparison when each emollient was applied twice daily for 5 days: • Doublebase DAYLEVE Gel was estimated to be approximately 10 times more hydrating than ZBC • The cumulative increase in skin hydration with ZBC was not statistically different from before treatment • Doublebase DAYLEVE Gel achieved substantial, long-lasting and cumulative skin hydration

Doublebase DAYLEVE Gel provides an effective twice-a-day alternative for those patients who find it difficult to adhere to a more frequent emollient routine.

Doublebase DAYLEVE Gel is an enhanced, long-lasting emollient, containing 30% oils together with a high level of glycerol and the addition of the film-forming agent povidone, making it a unique formulation with superior hydration.

The hydration effects of different emollients, including Doublebase DAYLEVE Gel (DDG), E45* and CBC,‡ were compared on ex-vivo human skin samples using corneometry,1 following a single-application of each product. Corneometry readings were taken at baseline and repeated 1h, 4h, 8h and 24h after application.

Latest evidence

Hydration level (arbitrary units)

100

Formulation DDG Formulation CBC

80

Formulation E45 untreated control

65 Mean Corneometry measurement

At least 12 hours protection from one LEVE-on application1

n=18 patients randomised

55

45

35

60 25

40

0 Day 1

20 0

12

24 Day 2

36

48 Day 3

60

72 Day 4

84

96 Day 5

Hrs post baseline day 1 to 5 (measurements nominally at 9am, 1pm & 5pm) 0

2

4

6

8

10

12 14 16 18 20 Time (hours) Comparative hydration levels of DDG, E45 and CBC (n=6)

22

DELP treated legs

24

• Skin hydration levels following application of Doublebase DAYLEVE Gel (DDG), were elevated by approximately 75% when measured 1h after application • After 24h, hydration levels were still approximately 30% higher than at baseline or 50% higher compared to untreated sites • In contrast, E45 and CBC showed very limited evidence of any improvement in skin hydration at any time, whether compared with baseline or untreated sites

ZBC treated legs

Note: Lines are joined for ease of viewing. Only the symbols show actual corneometry measurements

Proven: When used twice daily, Doublebase DAYLEVE Gel achieved substantially better and longer-lasting skin hydration and was generally preferred by subjects when compared to a widely prescribed cream emollient (DIPC # ).3

Proven efficacy if used only twice a day and preferred by patients, Doublebase DAYLEVE Gel can provide economical treatment, in both cost and time.

Dermal provides an extensive support programme, designed to help support patients and healthcare professionals in the management of dry skin conditions. ™

Isopropyl myristate 15% w/w, liquid paraffin 15% w/w.

Uses: Long lasting, highly moisturising and protective hydrating gel for dry skin conditions. Directions: Adults, children and the elderly: Apply direct to dry skin morning and night, or as often as necessary. Contra-indications, warnings, side effects etc: Please refer to SPC for full details before prescribing. Do not use if sensitive to any of the ingredients. In the rare event of a reaction stop treatment.

Instruct patients not to smoke or go near naked flames. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a potential fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Package quantities, NHS prices and MA number: 100g tube £2.65, 500g pump dispenser £6.29, PL00173/0199. Legal category: P . MA holder: Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK. Date of preparation: May 2019. ‘Doublebase’ and ‘Dayleve’ are trademarks.

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.

Adverse events should also be reported to Dermal.

References: 1. Gallagher J., Rosher P., Novac O. & Antonijevic M. (2018). Skin hydration comparison of five prescribed emollients. Data presented at the 2018 AAD Annual Meeting, February 2018, San Diego, USA. 2. Djokic-Gallagher J., Rosher P., Oliveira G. & Walker J. (2017). A Double-Blind, Randomised Study Comparing the Skin Hydration and Acceptability of Two Emollient Products in Atopic Eczema Patients with Dry Skin. Dermatology and Therapy, 7(3): 397-406. 3. Djokic-Gallagher J., Rosher P., Walker J., Sykes K. & Hart V. (2016).

Emollient efficacy and acceptability in the treatment of eczematous dry skin: A double-blind, randomised comparison of two UK-marketed products. Journal of Dermatological Treatment 2016 27(5):461-466.

E45* = E45 Cream, a registered trademark of Reckitt Benckiser Healthcare; CBC‡ = Cetraben® Cream and ZBC† = Zerobase® Emollient Cream registered trademarks of Thornton & Ross Ltd; DIPC# = Diprobase® Cream Emollient registered trademark of Bayer plc.

11mm

www.dermal.co.uk

DXXPR213/NOV20

Doublebase Dayleve Gel

GUEST EDITORIAL

Now is the time to start taking NMSC more seriously Anju Bhalla, Head of Oncology and Haematology at Sanofi Genzyme

N

on-melanoma skin cancer (NMSC) is significantly under-recognised. It is by far the most common form of cancer in the UK with more cases than breast, lung and prostate cancers combined.

Yet few members of the public are aware of its toll on the NHS and those affected.

The number of new cases has risen by a concerning 166% since the early 1990s. By 2025, it is expected there will be almost 400,000 people a year diagnosed with NMSC. For a disease considered largely preventable – as most cases are caused by over-exposure to UV light – this is unacceptable.

For this reason, Sanofi Genzyme organised a roundtable in November 2020 convening parliamentarians, clinicians, professional groups (including representation from the British Dermatological Nursing Group) and patient advocates to hear about the impact of NMSC on individuals, families, and the NHS. The first-hand testimony of patients and those at the NHS front-line highlighted its potentially devastating emotional and physical effects.

The risks of NMSC NMSC tumours most often appear on visible, sun-exposed areas such as the face and hands, considerably impacting self-esteem. Surgery to remove tumours can lead to disfigurement, further adding to the emotional burden of the disease. Larger tumours can affect breathing, hearing, and vision. And in the small number of cases when NMSC spreads to other parts of the body, there are limited treatment options and life expectancy is poor.

6

Beyond the personal toll, the volume of NMSC patients is placing a huge burden on already overstretched NHS services. Inevitably, the rise in patient numbers means increasing costs. The total cost of in-patient care for NMSC in England was an estimated £150.5 million in 2019, up 8.2% from the previous year.

NMSC tumours most often appear on visible, sunexposed areas such as the face and hands Impact of COVID-19 It will come as no surprise that the COVID-19 pandemic has had a major impact. During the roundtable we heard that while skin cancer services have continued to treat high-risk patients, there is a significant backlog of patients whose treatment has been delayed. Given the sheer volume of NMSC patients, this is adding considerably to national outpatient waiting lists.

Despite enormous efforts by the NHS to maintain access to services, patients are slipping through the net, either because they are shielding or too afraid to visit hospitals. During the first wave of the pandemic, the number of urgent NMSC referrals fell by 27% compared to predicted rates for 2020. Clinicians present at the roundtable discussed how they were wary of an oncoming wave of cases that have advanced without detection, requiring more complex treatment with poorer outcomes.

The case for action It is clear that there is an urgent need for concerted action.

Dermatological Nursing, 2021, Vol 20, No 2

Prevention and early detection are critical. Just 23% of UK adults can correctly identify the four most common signs of NMSC. We must talk openly about checking our own bodies for any change in the appearance of our skin and remember that any concerns we have should always be checked over by a healthcare professional. There is also an urgent need to better equip the workforce. GP training in dermatology is limited, making it difficult for GPs to correctly distinguish between cancerous and non-cancerous lesions. Out of caution, this leads to a high number of referrals, piling pressure on stretched dermatology services. A similar pattern was noted across the clinical pathway, especially amongst specialised dermatology nurses, who are so closely intertwined with the patient experience. Dermatological nurses are in critically short supply. Participants at the roundtable agreed that Health Education England should seek to review and increase the number of dermatology training places for trainee healthcare professionals, to reflect the rapidly rising prevalence of NMSC. Sanofi Genzyme are keen that these important conversations don’t stop and will continue to work with and bring together stakeholders to discuss what needs to be done to support the NHS and its workforce to recover services and restore care for NMSC patients to pre-pandemic levels.

June 13th marks World NMSC Day – we look forward to working with parliamentarians and other stakeholders to raise awareness of this important issue. We want to see care and outcomes of this disease dramatically improved to support the dermatological workforce, the NHS and NMSC patients alike. DN www.bdng.org.uk

Offers an effective, simple and different approach

Why is Adex Gel Different?

Highly moisturising and protective emollient gel which also contains an added ancillary anti-inflammatory medicinal substance to help reduce inflammation and redness Offers an effective, simple and different approach to the treatment and management of mild to moderate eczema, contact dermatitis and psoriasis

Benefits of Adex Gel

Evidence for Adex Gel When used for patients with eczema and psoriasis, study data showed that: patients’ feedback after using Adex Gel was very positive1 nearly 95% of patients found their skin benefited from using Adex Gel1 approximately half of the patients reported that they needed to use less of their other anti-inflammatory treatments when using Adex Gel. The remainder used about the same amount and none used more of their anti-inflammatory treatments1

✓ Developed for dry skin conditions prone to inflammation, such as mild to moderate eczema and psoriasis ✓ An easily absorbed, highly moisturising gel ✓ Specially formulated emollient with added nicotinamide to help reduce inflammation and redness ✓ Recommended for use as long as necessary – either occasionally, such as during flares, or continuously ✓ Suitable for frequent and regular application ✓ Steroid free ✓ Can be used all over the body including on the face and on creases of the skin ✓ For use by adults, the elderly and children aged 1+

Simple to prescribe, simple to use

Visit AdexGel.com for further information

Reference: 1. Djokic-Gallagher J., Rosher P., Hart V. & Walker J. Steroid-sparing effects and acceptability of a new skin gel containing the anti-inflammatory medicinal substance-nicotinamide. Clinical, Cosmetic and Investigational Dermatology 2019;12:545-552.

Adex Gel ™

Presentation: White opaque gel.

Uses: Highly moisturising and protective emollient with an ancillary anti-inflammatory medicinal substance for the treatment and routine management of dry and inflamed skin conditions such as mild to moderate atopic dermatitis, various forms of eczema, contact dermatitis and psoriasis.

Directions: Adults, the elderly and children from 1 year of age. For generalised all-over application to the skin. Apply three times daily or as often as needed. Adex Gel can be used for as long as necessary either occasionally, such as during flares, or continuously. Seek medical advice if there is no improvement within 2-4 weeks.

Contra-indications, warnings, side effects etc: Do not use if sensitive to any of the ingredients. Keep away from the eyes, inside the nostrils and mouth. Temporary tingling, itching or stinging may occur with emollients when applied to damaged skin. Such symptoms usually subside after a few

days of treatment, however, if they are troublesome or persist, stop using and seek medical advice. Rarely skin irritation (mild rashes) or allergic skin reactions can occur on extremely sensitive skin, these tend to occur during or soon after the first few uses and if this occurs stop treatment. Vitamin B derivative requirements are increased during pregnancy and infancy, however, with prolonged use over significant areas, it may be possible to exceed the minimum recommended levels of nicotinamide in pregnancy.

Safety trials have not been conducted in pregnancy and breast feeding therefore, as with other treatments, caution should be exercised, particularly in the first three months of pregnancy.

Instruct patients not to smoke or go near naked flames. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a potential fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Ingredients: Carbomer, glycerol, isopropyl myristate, liquid paraffin, nicotinamide, phenoxyethanol, sorbitan laurate, trolamine, purified water.

Pack sizes and NHS prices: 100g tube £2.69, 500g pump pack £5.99.

Legal category: Class III medical device with an ancillary medicinal substance.

Further information is available from the manufacturer: Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK. Date of preparation: July 2020.

‘Adex’ is a trademark.

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.

Adverse 11mm events should also be reported to Dermal.

www.dermal.co.uk

ADXPR230/SEP20

Essential Information

EDITORIAL

Emergency Steroid Cards and guidance for dermatology nurses Polly Buchanan Polly Buchanan is a Community Dermatology Nurse Specialist at NHS Fife, Queen’s Nurse, and Clinical Editor of Dermatological Nursing.

I

n the BDNG news e-Bulletin sent on 30th April 2021, there was a notification relating to Emergency Steroid Cards, with links to related papers and guidance. Having read the notification and relevant papers I thought it important to again bring this issue to the attention of our readers. This is not to be alarmist, but to support and guide readers to the relevant, up-to-date evidence and guidance, which will inform our practice and keep our patients safe.

In August 2020, NHS England, supported by the Royal College of Physicians, Royal College of General Practitioners and the Society of Endocrinology, issued a National Patient Safety Alert¹ for the dissemination of patient held Steroid Emergency Cards to support early recognition and treatment of adrenal crisis in adults. This was due to several associated deaths.

This relates to all adult individuals who are steroid dependent and at risk of adrenal insufficiency, including primary adrenal insufficiency (Addison’s disease, congenital adrenal hyperplasia, and Hypothalamo-pituitary damage) as well as those at risk of secondary adrenal insufficiency due to intake or application of exogenous steroids (oral, injection, inhaled, nasal, rectal and topical).1 Guidance has been published and can be accessed at: https://www.rcpjournals. org/content/clinmedicine/20/4/371. The guidance outlines the steps which can 8

be taken to avoid adrenal crisis in at-risk individuals should they become seriously ill, traumatised or require surgery.

Specific actions were highlighted which were to be in place by 31st May 2021. These include: Awareness of the issue for all healthcare professionals Complete review of policies, processes, procedures and electronic prompts relating to steroid prescriptions to ensure prescribers also issue a card if appropriate.

Patient held emergency steroid cards are available from: http://www.nhsforms. co.uk/ and at: https://secure.pcse.england. nhs.uk/_forms/pcsssignin.aspx In response to this new guidance, David Erskine, Specialist Pharmacy Services (SPS), and Helen Simpson, on behalf of the Society for Endocrinology Steroid Emergency Card working group, published a paper which comprehensively addresses the issues surrounding exogenous steroids, adrenal insufficiency, and adrenal crisis with clear guidance on identifying those at risk and management strategies.2 This guidance has been endorsed by the British Association of Dermatologists and the Society of Endocrinology.² I strongly recommend reading this guidance and incorporating relevant assessments, procedures and patient education into nursing practice. For us, the relevance of this paper lies mainly in the supply and administration of topical corticosteroids (TCS), which is an everyday practice in dermatology. It will be important for us to consider our prescribing practice, especially where the use of potent or very potent topical corticosteroids are utilised.

Dermatological Nursing, 2021, Vol 20, No 2

This guidance also advocates assessment and monitoring of all exogenous steroids, whether oral, articular, inhalational, nasal, rectal, or topical. The total accumulation of all steroids can, to a lesser or greater extent, put the patient at risk of adrenal insufficiency, especially if longer term use of potent or super potent steroids are applied topically (>200g potent TCS / week for four weeks or more), which may also include daily inhaled steroids or short course oral steroids.

It is important we are aware of this new guidance so that we can reassure patients and colleagues of safe and effective practice and avoid any further steroid phobia. It is likely few of our patients will require an emergency steroid card, but not impossible. It is very reassuring to know that best practice already includes individual written patient care plans which clearly define reducing regimens for potent and super potent TCS. DN

References: 1. Society for Endocrinology Clinical Committee and the Royal College of Physicians Patient Safety Committee 2020. Guidance for the prevention and emergency management of patients with adrenal Insufficiency. Available at: https://www.rcpjournals.org/ content/clinmedicine/20/4/371 [last accessed June 2021] 2. Erskine D, Simpson H. Exogenous steroids, adrenal insufficiency and adrenal crisis: Who is at risk and how should they be managed safely. Specialist Pharmacy Services (SPS), Society for Endocrinology Steroid Emergency Card Working Group 2021.

Available at: https://www.endocrinology.org/media/4030/ spssfe_supporting_sec_-final_hls-19022021-2-1.pdf [last accessed June 2021].

Resources: NHS England: https://www.england.nhs.uk/2020/08/ steroid-emergency-card-to-supportearly-recognitionand-treatment-of-adrenal-crisis-in-adults For any enquiries about this alert contact: patientsafety. enquiries@nhs.net www.bdng.org.uk

CONVENTIO

Methyl amino

ONAL

olevulinate

Methyl aminolevulinate

on your AK marks DAYLIGHT

Convenient Actinic Keratoses (AK) treatment session, Methyl aminolevulinate

! e n o d … t e s get Think PDT for treating AK; think METVIX first for proven clinical outcomes1–3

METVIX is indicated in adults (≥18 years) for the treatment of: Thin or non-hyperkeratotic and non-pigmented actinic keratoses on the face and scalp1.

METVIX, a convenient treatment made for patients - so they can get back to what matters PI Metvix 160 mg/g cream Abbreviated Prescribing Information (UK & IRE) Presentation: Cream containing 160mg/g of methyl aminolevulinate (as hydrochloride). Indications: Treatment in adults over 18 years of thin or non-hyperkeratotic and non-pigmented actinic keratoses on the face and scalp.

Only for treatment of superficial and/or nodular basal cell carcinoma unsuitable for other available therapies due to possible treatment related morbidity and poor cosmetic outcome; such as lesions on the mid-face or ears, lesions on severely sun damaged skin, large lesions, or recurrent lesions.Treatment of squamous cell carcinoma in situ (Bowen´s disease) when surgical excision is considered less appropriate. Dosage and administration: AK, BCC and Bowen’s disease using red light. For treatment of actinic keratoses (AK) one session of photodynamic therapy should be administered. For treatment of basal cell carcinoma (BCC) two sessions should be administered with an interval of one week between sessions. Before applying Metvix cream, the surface of AK and superficial BCC lesions should be prepared to remove scales and crusts and roughen the surface of the lesions. Nodular BCC lesions are often covered by an intact epidermal keratin layer which should be removed. Exposed tumour material should be removed gently without any attempt to excise beyond the tumour margins. Apply Metvix cream (about 1mm thick) using a spatula to the lesion and surrounding 5-10mm of normal skin. Cover the treated area with an occlusive dressing for 3 hours. Remove dressing, and clean with saline and immediately expose the lesion to red light with a continuous spectrum of 570-670nm and a total light dose of 75J/cm2. Multiple lesions may be treated during the same treatment session. Lesion response should be assessed after three months, and it is recommended to confirm the response of BCC lesions by histological biopsy. AK and BCC lesion sites that show non- complete response may be retreated if desired. AK using daylight Daylight treatment may be used to treat mild to moderate AK lesions. One treatment should be given. Treatment lesions should be evaluated after three months and if there is incomplete response, a second treatment may be given. Daylight treatment can be used if the temperature conditions are suitable to stay comfortably outdoors for 2 hours. If the weather is rainy, or is likely to become so, daylight treatment should not be used. A sunscreen should be applied. Once sunscreen has dried, scales and crusts should be removed from the lesions and the skin surface roughened before applying a thin layer of Metvix to the treatment areas. No occlusion is necessary. Patients should go outside after Metvix application or, at the latest, 30 minutes later in order to avoid excessive protoporphyrin IX accumulation which would lead to greater pain on light exposure. In order to minimize pain and ensure maximum efficacy the patient should then stay outdoors for 2 continuous hours in full daylight and avoid going indoors. On sunny days, should the patient feel uncomfortable in direct sunlight, shelter in the shade may be taken. Following the 2-hour exposure period, Metvix should be washed off. Please refer to summary of product characteristics before use. Contraindications: Hypersensitivity to the active or excipients, including arachis oil or peanut or soya. Morpheaform basal cell carcinoma. Porphyria. Precautions and Warnings: When using red light, should only be administered in the presence of a health care professional trained in the use of photodynamic therapy with Metvix. When using daylight treatment, a sunscreen should be applied to all areas exposed to daylight, prior to lesion preparation. Sunscreen used should offer adequate protection (SPF30 or higher) and must not include physical filters (e.g. titanium dioxide, zinc oxide, iron oxide). Only sunscreens with chemical filters should be used with daylight treatment. Not recommended during pregnancy. Only limited experience is available in relation to the treatment of actinic keratosis and/or Bowen’s disease amongst transplant patients on concomitant immunosuppressive therapy. A close monitoring of these patients ,with re-treatment if necessary is recommended in this population. There is no experience in treating Bowens disease in patients with a history of arsenic exposure.

There is no experience of treating pigmented or highly infiltrating lesions with Metvix cream. Thick (hyperkeratotic) actinic keratoses should not be treated with Metvix. Methyl aminolevulinate may cause sensitization by skin contact resulting in angioedema, application site eczema or allergic contact dermatitis. The excipient cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis), methyl- and propylparahydroxybenzoate (E218, E216) may cause allergic reactions (possibly delayed). Any UV-therapy should be discontinued before treatment. As a general precaution, sun exposure on the treated lesion sites and surrounding skin has to be avoided for a couple of days following treatment. Direct eye contact with Metvix cream should be avoided. Metvix cream should not be applied to the eyelids and mucous membranes. Pain during illumination with red light may induce increased blood pressure.

Measure blood pressure in patients prior to treatment. If severe pain occurs during treatment, the blood pressure should be checked. In case of severe hypertension, the illumination with red light should be interrupted in addition to taking appropriate symptomatic measures. Pregnancy and lactation: There is no or limited data from the use of methyl aminolevulinate in pregnant women. Metvix is not recommended during pregnancy and in women

of childbearing potential not using contraception. It is unknown whether methyl aminolevulinate /metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Metvix therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Undesirable effects: Approximately 60% of patients experience reactions localised to the treatment site that are attributable to toxic effects of the photodynamic therapy (phototoxicity) or to preparation of the lesion. The most frequent symptoms are painful and burning skin sensation typically beginning during illumination or soon after and lasting for a few hours with resolving on the day of treatment.

The symptoms are usually of mild or moderate severity and rarely require early termination of illumination.The most frequent signs of phototoxicity are erythema and scab. The majority are of mild or moderate severity and persist for 1 to 2 weeks or occasionally longer. Repeated treatment with Metvix is associated reduced frequency and severity of local phototoxic reactions.The incidence of adverse reactions in a clinical trial population of 932 patients receiving the standard treatment regimen with red light and from post marketing surveillance are shown in the table below.

Body system (MedDRA) Frequency Nervous system disorders Common (≥1/100, <1/10) Not known Eye disorders Vascular disorders Gastrointestinal disorders Skin and subcutaneous tissue disorders

Uncommon (≥1/1000, ≤1/100)

Fatigue

Uncommon (≥1/1000, ≤1/100) Not known Uncommon (≥1/1000, ≤1/100) Not known Uncommon (≥1/1000, ≤1/100) Very common (≥1/10) Common (≥1/100, <1/10) Uncommon (≥1/1000, ≤1/100) Not known

General disorders and administration site conditions

Prescribers should consult the summary of product characteristics in relation to other side effects. MA Numbers: PL 10590/0048 (UK) & PA 590/20/1 (Ireland) Packaging Quantities and Cost: Tube of 2 gram, UK - £171.50 (NHS), Ireland - €227.00 Legal Category: POM Full Prescribing Information is Available From: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts. WD17 1DS, UK. Tel: +44 (0) 1923 208950 Fax: +44 (0) 1923 208998 Date of Revision: May 2020

References: 1. Galderma. Metvix 160 mg/g cream SmPC, Feb 2021.

2. Rubel DM, et al. Br J Dermatol 2014;171(5):1164–71. 3. Lacour JP, et al. J Eur Acad Dermatol Venereol 2015;29(12):2342–8.

UKI-MVR-2100001 DOP May 2021

Common (≥1/100, <1/10)

Adverse reaction Paraesthesia, headache Transient global amnesia (including confusional state and disorientation) Eye swelling, eye pain Eyelid oedema Wound haemorrhage Hypertension Nausea Pain of skin, skin burning sensation, scab, erythema Skin infection, skin ulcer, skin oedema, skin swelling, blister, skin haemorrhage, pruritus, skin exfoliation, skin warm Urticaria, rash, skin irritation, photosensitivity reaction, skin hypopigmentation, skin hyperpigmentation, heat rash, skin discomfort Angioedema, face oedema (swelling face), application site eczema, allergic contact dermatitis, rash pustular (application site pustule) Application site discharge, feeling hot

Adverse events should be reported.

For the UK: Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

For Ireland: Suspected adverse events can be reported via HPRA Pharmacovigilance, Website: www.hpra.ie; Adverse events should also be reported to Galderma (UK) Ltd. E-mail: Medinfo.uk@galderma.com; Tel: +44 1 923 208950

Historical FOCUS

Para-medical skin camouflage is for everyone Elizabeth Allen

In this article, Elizabeth Allen looks at the evolution and role of camouflage when working with people from ethnic minority backgrounds.

Allen E. Para-medical skin camouflage is for everyone. Dermatological Nursing 2021. 20(2):10-13.

Sir Archibald McIndoe’s philosophy was to treat patients 50% medically and 50% psychologically. He was the Royal Air Force (RAF) plastic surgeon who treated the air crew’s burn injuries during the Second World War. He realised that a topically applied “cosmetic” that would replicate natural skin colours – but which could cover erythema, hypo and hyper pigmentation scarring – could help his patients regain confidence and selfesteem. McIndoe’s patients formed a self-help support group, known as The Guinea Pig Club. They shared the attitude that it was a bonus if something worked, and if it didn’t, at least there was nothing to lose.

Sir Archibald McIndoe enjoying a pint and a song with his patient © The Guinea Pig Club

Elizabeth Allen is a member of the BDNG Psychodermatology Sub Committee, and part of the BDNG Aesthetic group. She is also the author of Cover, the principles and art of paramedical skin camouflage (Authorhouse 2010).

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McIndoe first consulted with Hollywood to discover what they were using for technicolour filming; in particular how they waterproofed the makeup for the Busby Berkeley spectacularly choregraphed Esther Williams swimming scenes. Armed with this information, he contacted a colleague, analytic chemist Thomas Blake, to devise waterproof, long-lasting crèmes.

By the early 1950s they had created three colours, “light” “medium” and “dark”, which were suitable for his patients who (using the Fitzpatrick Classification Scale) were all skin groups I and II. At this time, it must be noted, most of Hollywood, television and day makeup catered only for those groups too.

During the early 1950’s the British Association of Skin Camouflage’s founder, Joyce Allsworth, was involved in suggesting additional colours to Thomas Blake (Veil being the brand name). Brown and Yellow were her two “must have” requests, as either or both in combination with any of the light, medium or dark colours would transform the crème’s colour to match skin groups III and IV. A pink/rose colour was later added because this too could be used to modify the skin coloured crèmes.

BASC are proud that such interaction and consultation with the skin camouflage manufacturers continues to

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Original Veil 3 colours © BASC

Cool group - red-blue undertones © BASC

Warm group - yellow undertones © BASC this day. We are also frequently asked for advice from cosmetic houses who have concealers and highly pigmented foundations available over the counter.

Over the following decades it became obvious that to suit the demographic changes in the UK (and within performing arts) it would be necessary to increase www.bdng.org.uk

Historical FOCUS the range of skin colours to cater for all groups I to VI, and to create the different skin tones, from pale through to dark, within individual groups.

Four additional skin camouflage brands – Covermark, Dermablend, Dermacolor and Keromask (together with Veil) were recognised by the British Medical Association (BMA) as coping tools for all patients with non-infectious skin conditions and scarring. These were then made available on NHS prescription; listed as Borderline Substances within the Monthly Index of Medical Specialities.

L’Oreal withdrew Dermablend from NHS prescription in 2005, but the brand remains available over the counter and on internet sales (as do Covermark, Dermacolor, Keromask and Veil).

Unfortunately, devolution and the formation of localised health trusts now means that skin camouflage provision depends on local funding agreements.

Their interpretation is no longer uniform regarding where on the person, what skin conditions or scarring are acceptable and what brands will be prescribed.

Regrettably, this causes great confusion between prescribers, dispensing chemists and patient alike. Skin camouflage provision comes under what is politely referred to now as a “postcode lottery”.

Vitiligo is one of the conditions accepted for camouflage © BASC member 2158

Over 350 colours © BASC

Complementary colours © BASC

Keeping pace with need It is reassuring to know that those specialist brands increased their colours to keep pace with needs. Today there are more than 350 coloured crèmes and a large range of setting powders to suit the undertone of the camouflage product.

Tattoo cover © BASC member 2158

Skin, lesions and products have either a red-blue undertone (as evident in skin group I and VI) or yellow (as seen in skin groups, II, III, IV and V). Of course, it would be completely inappropriate to refer to people as such. Good practice dictates that the red-blue groups are known as the “cool” skins, while the yellow groups are called “warm” skinned.

The trick with successful skin camouflage is to match the patient’s undertone to that of the product, otherwise the camouflage will appear “greyed” on the person’s skin.

Hypopigmentation and keloid hyperpigmentation patient preferred not to camouflage the keloid with a suitable complementary © BASC

www.bdng.org.uk

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Historical FOCUS We all see colour slightly differently and artificial light will slightly change the colour of someone’s skin, a skin condition and skin camouflage cremes.

Consultations should be under natural lighting conditions (whilst maintaining privacy) as then the chosen skin colour crème will remain correct under all lighting conditions. It is essential that the patient decides which colour they consider to be an acceptable match to their unaffected skin from the various colours tested. Should the consultant’s opinion override that of the patient, then the crème will not be used, and the patient will be very dissatisfied with the concept of using skin camouflage.

Fingertip application, setting powder applied © BASC

Finding the right colour match There are plenty of other factors to consider too. There is a difference in texture, pigment density and lifestyle suitability. Some brands are better in humidity, others are easier to spread over large areas of affected skin. Allowing the patient full choice, the consultation should try suitable samples from all the brands.

There are additional complementary colours, which act as an undercoat over hyperpigmented lesions before the skin match is applied. The complementary colour theory cites green as the opposite to red (erythema), however, you might find using the cool/warm skin theory above gives a better result.

Skin camouflage consultations are designed to empower the patient to make informed choices. Sometimes using a complementary colour is rejected by the patient as they prefer to maintain the hyperpigmentation over, for example, keloid scarring. This is understandable, as any hypertrophic scar or skin condition will always be obvious.

When using medication, sunscreen, silicone gel (not the sheeting) and emollients which are applied to the skin, allow a few minutes for the preparation to be absorbed before blotting off any excess and applying the camouflage.

Application of the acceptable skin match colour is usually applied using fingertips, ensuring hygienic practices, with the setting powder being patted on with a soft pad.

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Lipstick also used © BASC

Camouflage beard shadow applied over acceptable skin match © BASC

Staining pen used over depigmented lips © BASC member 2151

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www.bdng.org.uk

Historical FOCUS

Patient’s left hand has camouflage applied © BASC member 2160 When correctly applied, the camouflage should not be noticeable © BASC member 2160

Faux tan (over natural sun-tanned skin) © BASC member 2158 Powder applied over the acceptable skin match may give a matte result – fixing spray will restore natural glow © BASC Skin camouflage is very versatile, it can be used in conjunction with decorative makeup, which allows the wearer to continue using their favourite makeup. Camouflage crème can also be used to replicate beard shadow.

Staining pens are also available, which are suitable for creating a natural lip colour – these are not available on prescription. They resemble felt-tip pens which make them ideal for those who do not wish to carry a bullet-shaped longlasting lipstick in their pocket.

When correctly applied, the camouflage should not attract attention or be noticeable. However, if the setting powder gives a matte result (which would attract attention to the camouflaged skin) a fixing spray can be used to return the area to a natural skin glow.

Limitations of camouflage Skin camouflage does not alter the form or function of the skin – it is not curative. The scarring or skin condition will remain, but it does lessen the visual www.bdng.org.uk

appearance. Why should anyone be expected to discuss their medical history when a stranger asks “what’s happened to your skin?”

Whilst the brands mentioned above are waterproof, allowing the patient to go swimming or shower, it must be remembered that none are totally rub-proof. We know a gentle pat over wetted camouflage should not remove it (to do that a soap substitute or oil-wax based cleansing product is needed); but this immediately creates a problem with hand hygiene.

Camouflage applied to fingers and/ or the back of a hand will be removed each time the hands are washed.

Vulnerability and embarrassment would result should the camouflage rub off onto to equipment (such as a mobile phone), paperwork, or even to another when shaking hands. To explore ways to overcome this problem BASC, in conjunction with the Vitiligo Society, conducted a PATCH survey (Products Available To Camouflage Hands) in August 2013.

The vitiligo volunteers were issued with a selection of decanted products (labelled 1, 2, 3, etc) that included theatrical cosmetics, faux tans, traditional camouflage, and overthe-counter long-lasting cosmetics.

The accompanying questionnaire asked for the number of times they washed their hands daily and which unidentified product lasted the longest or was preferred. The trial was over a three-month period, with the results published in November 2014.

The fixing spray helped to keep traditional skin camouflage in place for a few hand-washes; the theatrical makeup activated and removed by ethanol was successful, but as these are designed for short-term use during filming, the medical professionals could not recommend them for long-term use.

Faux tan products were the favourite; the survey volunteers were willing to spend time carefully applying the product in the knowledge that it would last the week. However, as most tans available are suitable for skin groups I to III, we hope the manufacturers will now increase their range to accommodate products to mimic IV to VI. We’ll let you know when they do! DN

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Smart-thinking skincare, Zero compromise

www.zeroderma.co.uk

Quality Accredited by the British Skin Foundation

Quality Manufactured to pharmaceutical standards

Quality Manufactured in the United Kingdom for reliable supply

Quality Efficient air-free pumps to minimise contamination

Patient care Proven patient compliance and persistence

Patient care Surveys show high levels of patient satisfaction

Choice A comprehensive range for patient choice

Cost Cost-effective emollients and barrier creams

Visit our website for all the smart tools you and your patients need to manage dry skin conditions. www.zeroderma.co.uk

Clinical PRACTICE

What is the evidence base to support the nurse specialist when counselling adult patients considering a systemic treatment for atopic eczema?

Laura Crosby

This article looks at the rationale and evidence which can help nurse specialists when counselling patients who are considering taking systemic treatments, such as baricitinib and dupilumab for the treatment of atopic eczema. The article looks at how information is provided, the need for patients to understand risks and benefits, and the importance of giving the patient choice and control over their treatment.

Crosby L. What is the evidence base to support the nurse specialist when counselling adult patients considering a systemic treatment for atopic eczema? Dermatological Nursing 2021. 20(2):15-19

   

Atopic eczema Atopic eczema, or atopic dermatitis, is a chronic inflammatory skin condition.1 It is believed that external environmental irritants, such as the weather and soap, alongside the body’s genetically programmed immune response, combine to cause breakdown in the skin barrier and a cycle of increased immune response.2 This can lead to cracked, itchy, dry, and inflamed skin which presents further opportunities for irritants to breach the skin barrier.3 Laura Crosby is a Clinical Nurse Specialist in Medical Dermatology at University Hospital Bristol and Weston NHS Foundation Trust. www.bdng.org.uk

Developments in treatment options

Engaging patients in shared decision making

Dupilumab was licensed for use in the UK in 20184 and baricitinib became the second advanced therapy with approval from NICE in March 2021. 5 Several other advanced therapies are currently in the process of seeking NICE approval for the treatment of adult atopic dermatitis.

Commencing any planned treatment for atopic eczema should be a shared decision whenever possible, as it is believed that involving patients in their care and treatment plans improves patient compliance. 8 This means that patients should be involved in a thorough discussion about their proposed treatment, with a rationale for the treatment recommendation and a risk-benefit analysis.9 It is thought that this shared decision making is particularly important in relation to medication, as the patient will need to accept, understand and administer treatment.10 The nurse specialist can play an important role in this discussion by building trust with patients and ensuring they have a realistic understanding of the risks and benefits of treatment and should, therefore, ensure this is carried out in a timely and effective manner.9 There is a selection of literature8-11 which provides advice on what information

Commencing any planned treatment for atopic eczema should be a shared decision whenever possible The rapid developments in treatment options, in a previously difficult to treat condition, results in additional requirements to counsel and monitor patients prior to and during treatment.

The nurse specialist has a unique role supporting the patient on their treatment pathway by tailoring information delivery to meet their needs.7

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Clinical PRACTICE should be included in these discussions.

Maguire and Pitceathly8 include six points. These are all very patient focused and include: establishing patients’ understanding of their diagnosis, including the physical and emotional effects it has on them and their family; presenting information in an accessible and individualised way to the patient and checking their understanding of this information; and understanding the patients’ main concerns about the information being discussed.

Simply providing a leaflet does not offer patients the opportunity to discuss concerns at a deeper level

Figure 1.

Atopic dermatitis treament pathway.

(Taken from NICE6) Not taking Dupilumab

Taking Dupilumab

Coulter10 gives a much shorter list to guide discussion. This simply suggests discussing the benefits, risks, alternatives to suggested treatment and a discussion around the option of doing nothing. Oxman et al.11 give a lengthier checklist suggesting the clinician goes into detail about all aspects of the proposed treatment including absolute risk versus relative risk, as well as certainty of evidence.

For example, taking figures from Simpson et al.1 the absolute risk of developing conjunctivitis in adult atopic eczema patients taking dupilumab would be 13%. Relative risk would give a percentage increase in chance of developing conjunctivitis on dupilumab compared to those adults with atopic dermatitis who don’t take dupilumab.

If 8% of adults with moderate to severe atopic dermatitis will develop conjunctivitis and this figure goes up to 13% for those on dupilumab, this could be viewed as a relative increase in risk of 62.5%. Some patients may view this as a high risk, but the reality is that they still only have a 13% chance of developing conjunctivitis on dupilumab.

The relative risk figure can be misleading, so Oxman et al.11 advise using absolute risk to avoid such confusion. Whilst more thorough lists may be valid, they may not be easy to 16

Figure 2.

Conjunctivitis cases in adult patients with moderate to severe atopic eczema. follow during a verbal conversation with a patient. A simpler four step approach10 may be easier to remember and use during a face-to-face discussion. However, being familiar with the more detailed checklist would help to ensure the information discussed is accurate and not misleading. The British Association of Dermatologists (BAD) provides patient information leaflets which cover much of the information that we need to make available to patients. However, simply providing a leaflet does not offer patients the opportunity to discuss concerns at a deeper level, and it does not ensure patients have received the information in a way they can access

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and understand. It is a useful starting point for some patients as it provides a basic background for further discussion but it should not be used in place of counselling.

Understanding diagnosis and treatment options Some of the literature suggests starting discussions by ensuring patients understand their diagnosis and treatment options. 8,11 It is therefore necessary to ensure that patients understand the role of the skin and immune system in atopic eczema.

When discussing treatment options it may be appropriate to explain the different ways in which these work. www.bdng.org.uk

Clinical PRACTICE Patient information leaflets such as those produced by the BAD can be useful tools to begin these discussions.

However, the disease process and the mode of action of these treatments can be complicated, so there would need to be careful consideration of the way this information is presented to ensure patients are able to understand it. Siegel12 highlights the importance of presenting information using multiple methods. This may mean resources such as videos, diagrams (such as the graphic to represent conjunctivitis prevalence, above) and leaflets would be beneficial in supporting the discussion around disease and treatment methods.

Patient information videos such as those produced for dupilumab13 may be useful for communicating information with patients, provided caution is taken due to the source.

During this initial discussion it may also be worth introducing the method of administration as some patients may not be willing or able to tolerate injections on a regular basis, or may prefer infrequent injections over daily tablets, and this may impact on their decision to commence treatment.10 The nurse specialist may also choose to use training devices that simulate the administration of injectable treatments to demonstrate the method to patients. This may provide the patient with a practical and hands-on demonstration, which some patients could find useful.

Benefits and risks of treatment The checklists around patient risk discussions often include the benefits of a particular treatment.10,11 Using terminology that is appropriate for the individual patient is important to ensure the data is presented in a way that each patient can understand but that also provides enough information.12 Treatment being provided following the NICE Eczema care pathway will be evidence based and this evidence can be found by looking at the NICE Technology Appraisal Guidance (TAG) for the specific medication. For example, NICE, 5 which looks at the benefits and www.bdng.org.uk

research limitations of baricitinib. This research may not be in a format that is accessible to the entire patient group, meaning the nurse specialist would need to be able to read and interpret this information when discussing with a patient. The BAD14 has published a decision-making aid for biologic treatment of psoriasis which provides a more visual way of sharing similar information, and it may be useful to have a similar document for the treatment of atopic eczema.14 It is important to understand the patient’s main treatment goal8 to ensure consideration of this is discussed. Oxman et al.11 mention the importance of being consistent with terminology so it may be helpful to use the same tools throughout patient assessment, treatment benefits, and research and efficacy checks. NICE15 guidance refers to Eczema Area Severity Index (EASI)16 and Dermatology Life Quality Index (DLQI)17 scores so it may be that when discussing the benefits of a treatment it is useful to discuss research findings using these validated tools. However, this may not be appropriate if the patient has a goal which is not measured by the EASI or DLQI scores. Patients may be satisfied simply to know that the evidence from trials supports the use of a particular treatment, but it is important that the information is available if they wish to discuss this in greater detail. OsMedendorp et al9 highlights the need for this information to be presented in a way that meets the individual needs of the patient. Furthermore, Trevena et al.18 put forward evidence that patients understand risk better when it is presented in a variety of formats, including visual representations. It is therefore necessary to ensure that discussions around benefits are focused around the patient’s own goals and that the information is presented in an appropriate format for each individual.

It may be pertinent to discuss some of the limitations of the evidence, such as the lack of data around the longerterm benefits and unknown risks of newer treatments, or to discuss the

inclusion criteria for the trials, which may differ from real world population.

The nurse needs to differentiate ‘lack of evidence’ from ‘lack of effect’11 and it is important to ensure that the patient understands this concept.

Another point that may be significant when discussing trial data is the inclusion and exclusion criteria.

If a particular patient group is not adequately represented in the trial data then it may be appropriate to discuss this with the patient. An example of this would be the small numbers of certain ethnic groups enrolled in the three main dupilumab trials. This lack of evidence is discussed in the NICE4 guidance, which suggests that the cytokine pathways differ between ethnic groups. Whilst IL-4 and IL-13 are significant in most populations, the Asian population may have greater involvement of IL-17 and therefore the data may not be relevant in this population. It might be relevant to note that exclusion criteria are not discussed in this trial data and therefore we do not have figures relating to patients who may have been excluded. It may also be worth mentioning to patients the difference between trial outcomes and real world data. This may be useful according to some of the more detailed discussion checklists, which mention certainty and misleading evidence.11 However, Maguire and Pitceathly8 comment on the importance of presenting information in a format that patients can understand. It is unlikely that patients would need all the information on the limitations of research, but as a specialist nurse it would be necessary to distill out any relevant information and find an approachable way to present this to patients.

It is also important to discuss the potential risks and side effects. It may be appropriate to consider the likelihood and severity separately, since these may have an impact on the patient’s decision to commence treatment.11 A common low severity side effect may be one that the patient is willing to accept whilst a rare but very serious side effect may not.

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Clinical PRACTICE Reflecting on how this information can be tailored to each individual may ensure a more appropriate and patient-centred approach. This, if misunderstood, could unduly influence a patient’s decision and it should therefore be a priority to ensure this is managed in an individualised way.12 Siegel12 and Trevena et al18 recommend the use of pictorial or other visual representations of risk, such as Figure 2. This may include patient information leaflets from organisations such as BAD and drug manufacturers. Whilst these support materials may go some way to accommodating individual preference, they may not provide enough variety in the way information is presented. Therefore, it is essential that the nurse specialist finds an appropriate format in which to present this information to each individual patient.

Alternative options for treatment When discussing a proposed treatment with patients, Coulter10 and OsMedendorp et al.9 advocate inclusion of discussion of alternative treatments and the option to do nothing. The data

around the placebo group’s rate of infections in clinical trials could play a part in this discussion. The trials don’t specifically look at the risks associated with not commencing a treatment, but they provide a possible indication of increased risk. Alongside an understanding of the role of the skin barrier in preventing infection, it may be possible to link poorly controlled disease with a greater risk of skin infection.

Patients may be satisfied simply to know that the evidence from trials supports the use of a particular treatment Alternative options for patients should be discussed, even though the present treatment options for atopic eczema are likely to have been explored prior to commencing a higher-cost drug due to the NICE and Scottish Medicine Consortium4,19 criteria for access. It is, however,

possible for patients to reconsider options that were previously not considered, ruled out, or provided a partial response.

Counselling patients with different communication needs It is important to remember that not all patients will be able to engage with shared decision-making using written or spoken English language alone.

There are many groups of people who will require additional or alternative methods of communication. Some of these may be quite straightforward, such as providing information leaflets in a number of languages and using interpreters to support discussions.

NHS England20 highlights the need to identify and document communication or information needs at the first contact. This document goes on to list some prompts or questions that could enable the specialist nurse to identify any additional needs.

Patients who are not able to read information leaflets due to impaired vision may benefit from large print, Braille, or audio leaflets.

Figure 3.

Questions to help identify additional communication needs.

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www.bdng.org.uk

Clinical PRACTICE Patients with hearing loss may use a number of methods to support their communication, including hearing loops, lip-reading and sign language. As such, it would be important to establish what method or methods of communication each patient uses and to ensure these are accommodated and documented in every discussion. Patients with a learning disability may also have additional communication needs.

Depending on the disability it may be necessary to carry out consultations and counselling with the support of a patient advocate. Additionally, it may be useful to use simple pictures to assist in discussions. 21 All additional or alternative communication methods should be clearly documented in patient records as part of the consultation record.

References 1. Simpson EL, Bieber T, Guttman-Yassky LA, Beck A, Blauvelt MJ, Cork JI, Yancpoulos GD. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. The New England Journal of Medicine 2016. 375(24):2335-2348 2. Stanway A. Atopic Dermatitis. DermNet NZ 2004. Available at: https://dermnetnz.org/topics/ atopic-dermatitis/ [last accessed May 2021] 3. British Association of Dermatologists.

Atopic Eczema 2020. Available at: https://www.bad.org.uk/shared/get-file. ashx?id=69&itemtype=document [last accessed May 2021] 4. NICE National Institute for Health and Care Excellence. Dupilumab for treating moderate to severe atopic dermatitis 2018. Available at: https:// www.nice.org.uk/guidance/ta534 [last accessed May 2021] 5. NICE National Institute for Health and Care Excellence. Baricitinib for treating moderate to severe atopic dermatitis 2021: Recommendations.

Available at: https://www.nice.org.uk/guidance/ ta681/chapter/1-Recommendations [last accessed May 2021]

The nurse needs to differentiate ‘lack of evidence’ from ‘lack of effect’

6. NICE National Institute for Health and Care Excellence (2020) Baricitinib for treating moderate to severe atopic dermatitis: Slides for public.

Available at: https://www.nice.org.uk/guidance/ ta681/documents/1l [last accessed May 2021]

Conclusion

7. Oliver SM. The Role of the Clinical Nurse Specialist in the Assessment and Management of Biologic Therapies. Musckuloskeletal care 2011.

9:54-62

The nurse specialist should ensure that information is shared in an individualised way when counselling a patient. They also have a role as patient advocate.7 Often, they are the point of contact for a patient throughout their treatment and in a privileged position to build trust with the patient.7 For this reason, the nurse specialist is in a good position to form a close therapeutic relationship with patients and can therefore tailor discussions around treatment to suit the individual through use of clinical knowledge, understanding and suitable presentation resources.

In conclusion, considering diagnosis, treatment options, risks, benefits, and alternative treatments could be significant in the effectiveness of patient counselling prior to treatment with a systemic therapy. However, the method of sharing this information is crucial if the nurse specialist is to successfully enable the patient to fully understand the treatment they are being offered. DN www.bdng.org.uk

8. Maguire P, Pitceathly C. Key communication skill and how to acquire them. BMJ 2002. 325.

697-700 9. Os-Medendorp H, Deprez E, Maes N, Ryan S, Jackson K, Winders T et al. The role of the nurse in the care and management of patients with atopic dermatitis. BMC Nursing 2020. 19(102).

Available at: https://doi.org/10.1186/s12912-02000494-y [last accessed May 2021] 10 Coulter A. How to provide patients with the right information to make informed decisions.

The Pharmaceutical Journal 2018. 301(7915) DOI:10.1211/PJ.2018.20204936 11. Oxman AD, Glenton C, Flottorp S, Lewis S, Rosenbaum S, Fretheim A. Development of a checklist for people communicating evidencebased information about the effects of healthcare interventions: a mixed methods study. BMJ Open 2020. 10 doi:10.1136/bmjopen-2019-036348.

Available at: https://bmjopen.bmj.com/ content/10/7/e036348 [last accessed May 2021] 12. Siegel CA. Review article: explaining risks of inflammatory bowel disease therapy to patients.

Alimentary Pharmacology and Therapeutics 2011.

33:23-32 13. Dupixent 2020. Available at: https://www. dupixent.com/atopicdermatitis/about-dupixent/ how-dupixent-works [last accessed May 2021]

14. British Association of Dermatologists (BAD) Decision Aid for Biological Therapy for Psoriasis.

Available at: https://www.bad.org.uk/shared/getfile.ashx?id=6904&itemtype=d [last accessed May 2021] 15. NICE. Treating Eczema in people over 12. Available at: https://pathways.nice.org.uk/ pathways/eczema#path=view%3A/pathways/ eczema/treating-eczema-in-people-over-12. xml&content=view-node%3Anodes-adult-withatopic-eczema-or-hand-eczema [last accessed May 2021] 16. Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Experimental Dermatology 2001.

10(1):11-18 17. Finlay AY, Kahn GK. Dermatology Life Quality Index 1992. Available at: https://www. cardiff.ac.uk/medicine/resources/quality-of-lifequestionnaires/dermatology-life-quality-index [last accessed May 2021] 18. Trevena LJ, Zikmund-Fisher BJ, Edwards A, Gaissmaier W, Galesic M, Han PKJ et al.

Presenting quantitative information about decision outcomes: a risk communication primer for patient decision aid developers. BMC Medical Informatics and Decision Making 2013. 13 (Suppl 2). Available at: http://www.biomedcentral. com/1472-6947/13/S2/S7 [last accessed May 2021] 19. Scottish Medicines Consortium. Dupilumab 300mg solution for injection in pre-filled syringe (Dupixent) 2018. Available at: https://www. scottishmedicines.org.uk/medicines-advice/ dupilumab-dupixent-fullsubmission-smc2011/ [last accessed May 2021] 20. NHS England. Accessible Information Standard 2016. Available at: https://www.england. nhs.uk/wp-content/uploads/2016/04/Identifyinginformation-and-communication-needs.pdf [last accessed May 2021] 21. University Hospital Southampton (ND) The Hospital Communication Book. Available at: https://www.uhs.nhs.uk/Media/SUHTInternet/ PatientsAndVisitors/Learningdisabilities/HospitalCommunication-Book-new.pdf [last accessed May 2021].

BDNG Annual

Conference The BDNG is delighted to be holding our postponed 30th Annual Conference on 21 – 23 September 2021 at the Harrogate Convention Centre.

Dermatological Nursing, 2021, Vol 20, No 2

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DERMATOLOGICAL NURSING

Instructions to authors Why write for Dermatological Nursing?

Dermatological Nursing is a quarterly, peer-reviewed publication that aims to provide cutting-edge articles on the treatment and management of dermatological conditions and the care of patients with skin problems.

While the focus is on dermatological nursing, the information included will be relevant to other healthcare professionals. Writing for Dermatological Nursing can be a useful way to help develop and crystallise ideas about a specific topic, and may encourage exploration of an area in greater depth and lead to further understanding. Once you have made the decision to write for Dermatological Nursing, please contact the Managing Editor to ensure that what you are planning to write has not already been commissioned, and that it is appropriate for the readership. The article should be unpublished and have not been submitted for publication elsewhere.

Dermatological Nursing is available online to BDNG members at bdng.org.uk,which also offers a searchable archive of previously published articles.

Dermatological Nursing welcomes submissions for publication broadly in the following categories: 8 Clinical Skills/Clinical Review 8 Science in Practice 8 Research/Audit 8 Practice Development 8 Policy Review 8 Case Reports Once your idea has been given the all clear, the following guidelines should be adhered to when preparing your paper for submission.

Title page The title page should include: 8 Title of the article (ideally no more than 10 words) 8 The full names of the authors 8 Full details of each author’s current appointments, including place of work

Abstract/Summary This is typeset in bold at the beginning of the article. As a general guide, articles in the Research/Audit section of the journal have abstracts, while those in the other sections have a summary.

8 The Abstract should be no longer than 180 words in length and should contain the following headings: Background, Aims, Methods, Results, Conclusions, Declaration of interest.

8 The summary should be a very concise (no more than 90 words) accurate statement that captures the reader’s interest by setting the scene for the article.

20

Both the Abstract and the Summary should enable the reader to understand the scope and main conclusions of the article without having to read the rest of the paper.

Word count

Headings Throughout the article, use plenty of headings to break up the text and highlight the main points within the paper. Also remember to indicate the importance attached to each one.

Word count for all clinical articles (excluding title page, abstract/summary/tables) should not exceed 2800 words and 20 references. Case reports should not exceed 800 words and 5 references.

Abbreviation and units

Short introduction

Please provide 5 key words to appear at the start of your article, and if possible 3–5 key point sentences that summarise the main themes of your paper.

The introduction is designed to capture the reader’s interest by putting the article into the context of current clinical practice, quoting key references. It should also give the reader an idea of the objectives and contents of the paper. It should be clear and inviting.

Methods For papers describing original work (usually in the Research/Audit section), a concise but informative account of all techniques (including statistical methods) used should be provided, in order to enable the reader to reproduce the work if necessary. Published/standard methods can be referenced; detail is not necessary.

However, variations to the published procedure should be described.

Results For papers describing original work (usually in the Research/Audit section), a comprehensive and clear description of results with tables, graphs, etc, is required. As well as presenting data in pictorial form, a narrative account should be given, since the reader should not be expected to interpret results unaided.

Where appropriate, statistical procedures should be used to indicate the variability of results and to test the significance of differences.

Discussion Papers describing original work (usually in the Research/ Audit section) require a discussion. This should not be a repetition of results. It should summarise and interpret your conclusions and comment on their significance in light or what is already known from the literature.

Shortcomings in your work should be identified, and suggestions made as to what can be done to extend/ confirm your findings.

Conclusions For all papers, the conclusion should be succinct and logically ordered. It should identify gaps in knowledge and suggest future initiatives.

Dermatological Nursing, 2021, Vol 20, No 2

These should be defined at first mention. SI units should always be used.

Key words and key points

Tables and illustrations Tables and illustrations are helpful to demonstrate key data or points to the reader. It is the author’s responsibility to ensure that permission is received for reproduction. Please do not supply more than 10 tables or 10 figures. Please ensure all tables and illustrations have a table heading and figure legend, and are cited in the text.

Photographs No more than 10 figures (photos should be provided as jpeg or tiff (300dpi), permission for reproduction is the author’s responsibility. All should have legends and should be clearly labelled, and cited in the text.

References

Dermatological Nursing uses the Vancouver system of referencing (names cited numerically in text order).

The number of references should not exceed 20.

In the reference list: 8 References should be listed in numerical order.

8 The surname and initials of each author should be given in full for six or fewer authors. For seven or more, the names and initials of the first three should be given, followed by ‘et al’. The sequence for a journal reference is author(s), title, journal, year, volume, issue, page range. The sequence for books is author(s), title, publisher, year, chapter, page range.

Layout and punctuation for journal articles are: Leigh IM. Progress in skin cancer: the UK experience.

Br J Dermatol 2014, 171(3): 443-5 Sequence, punctuation and layout for books are as follows: Goodman LS, Gillman A. Goodman and Gillman’s the Pharmacological Basis of Therapeutics.

8th Edn. McGraw Hill, New York. 1990. 2: 6-8 Internet sources should be referenced as: Author or Editor, Year, Title [online]. Place of publication. Available at: <URL> [date accessed] DN

Contact details For further information, please email Rob Mair, Managing Editor, at rob.mair@pavpub.com www.bdng.org.uk

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SHARED RESULTS

SHARED RELIEF

DUPIXENT (dupilumab) is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in patients aged 12 years or older and for severe AD in children aged 6–11 years, who are candidates for systemic therapy1 First and only targeted immunomodulator to specifically inhibit IL-4 and IL-13 signalling, key drivers of persistent underlying Type 2 inflammation1,2

Dupixent (dupilumab) solution for injection in a pre-filled syringe or pen (Atopic Dermatitis) Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

Presentations: Dupixent 200 mg solution for injection in a pre- filled syringe or pen, containing 200 mg of dupilumab in 1.14 ml solution (175 mg/ml) or Dupixent 300 mg solution for injection in a pre-filled syringe or pen, containing 300 mg of dupilumab in 2 ml solution (150 mg/ml).

Indication: Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 to 11 years old who are candidates for systemic therapy.

Dosage and Administration: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of atopic dermatitis. Dupixent should be administered as subcutaneous (SC) injection, into the thigh or abdomen, except for the 5 cm around the navel. The upper arm can be used if not selfadministered. Dupixent can be used with or without topical corticosteroids. Topical calcineurin inhibitors should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas. Adults: the recommended initial dose of Dupixent is 600 mg (two 300 mg injections), followed by 300 mg given every other week (EOW). Adolescents (12-17 years) with body weight <60 kg: the recommended initial dose of Dupixent is 400 mg (two 200 mg SC injections), followed by 200 mg EOW. Adolescents (12-17 years) with body weight ≥60 kg: the recommended initial dose of Dupixent is 600 mg (two 300 mg SC injections) followed by 300 mg EOW. Children 6 to 11 years of age with body weight 15 kg to <60 kg: the recommended initial dose of Dupixent is 300 mg on Day 1, followed by 300 mg on Day 15. Subsequent doses of 300 mg every 4 weeks (Q4W) starting 4 weeks after Day 15 dose. The dose may be increased to 200mg EOW in these patients based on physician’s assessment. Children 6 to 11 years of age with body weight ≥ 60 kg: the recommended initial dose of Dupixent is 600 mg (two 300 mg injections), followed by 300 mg EOW. Missed dose: If a dose is missed, administer the dose as soon as possible.

Thereafter, resume dosing at the regular scheduled time.

Improvements with DUPIXENT compared to placebo at 16 weeks in all populations and now also in children aged 6–11 years1,3–8 – Lesion extent and severity1,3–7 – Pruritus intensity1,3–7 – Quality of life measures1,3–8

No or partial response: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment for atopic dermatitis. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. If Dupixent treatment interruption becomes necessary, patients can still be successfully re-treated. Proper training should be provided to patients and/or caregivers on the preparation and administration of Dupixent prior to use according to the Instructions for Use (IFU) section in the package leaflet.

Special populations: Elderly patients (≥65 years): No dose adjustment recommended. Renal impairment: No dose adjustment in patients with mild or moderate renal impairment. Very limited data available in patients with severe renal impairment. Hepatic impairment: No data available. Paediatric patients <6 years: No data available. Method of administration: The dupilumab pre-filled pen is not intended for use in children below 12 years of age. For children 6 to 11 years of age with severe atopic dermatitis, the dupilumab pre- filled syringe is the presentation appropriate for administration to this population.

Contraindications: Hypersensitivity to the active substance or to any of the excipients.

Warnings and Precautions: Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Hypersensitivity: If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of Dupixent should be discontinued immediately and appropriate therapy initiated. Anaphylactic reactions and angioedema have occurred from minutes up to seven days post injection. Helminth infection: Patients with known helminth infection were excluded from the clinical trials. Dupixent may influence the immune response against helminth infections by inhibiting IL-4/IL-13 signaling. Patients with pre-existing helminth infections should be treated before initiating Dupixent. If patients become infected while receiving treatment with Dupixent and do not respond to antihelminth treatment, treatment with Dupixent should be discontinued until infection resolves. Conjunctivitis and keratitis related events: Conjunctivitis and keratitis related events have been reported with dupilumab, predominantly in atopic dermatitis

Safety profile investigated in patients as young as 6 years old, consistent with safety profile of adolescents at 1 year and adults at 3 years1 – Does not require routine laboratory monitoring1

patients. Some patients reported visual disturbances (e.g. blurred vision) associated with conjunctivitis or keratitis. Patients should be advised to report new onset or worsening eye symptoms to their healthcare provider. Patients treated with Dupixent who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis should undergo ophthalmological examination, as appropriate. Comorbid asthma: Patients with comorbid asthma should not adjust or stop their asthma treatments without consultation with their physicians.

Patients with comorbid asthma should be monitored carefully following discontinuation of Dupixent.

Vaccinations: Live and live-attenuated vaccines should not be given concurrently with Dupixent as clinical safety and efficacy has not been established. It is recommended that patients should be brought up to date with live and live-attenuated immunisations in agreement with current immunisation guidelines prior to treatment with Dupixent. Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per 300 mg dose, i.e. is essentially “sodiumfree”. Interactions: Patients receiving Dupixent may receive concurrent inactive or non-live vaccinations.

One study evaluating the pharmacokinetic effects of Dupixent on CYP substrates did not indicate clinically relevant effects of Dupixent on CYP1A2, CYP3A, CYP2C19, CYP2D6 or CYP2C9 activity.

Fertility, pregnancy and lactation: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. There are limited data from the use of Dupixent in pregnant women. Animal studies do not indicate harmful effects. Dupixent should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. It is unknown whether Dupixent is excreted in human milk or absorbed systemically after ingestion. A decision must be made whether to discontinue breast-feeding or to discontinue Dupixent therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Adverse effects: Adults: Very common (≥1/10): Injection site reactions. Common (≥1/100 to <1/10): Conjunctivitis, oral herpes, eosinophilia, headache, conjunctivitis allergic, eye pruritus, and blepharitis.

Uncommon (≥ 1/1,000 to < 1/100): Keratitis, ulcerative keratitis. Very rare (< 1/10,000): Serum sickness/serum

sickness-like reaction. Not Known: Anaphylactic reaction, angioedema, and athralgia Serious adverse reactions: eczema herpeticum, infections and immunogenicity have also been reported. Adolescents (12-17 years): The safety profile of Dupixent in adolescents aged 1217 years followed through week 16 study and through a long- term study was similar to the safety profile from studies in adults with atopic dermatitis. For full details please consult SmPC. Children (6-11 years): The long term safety profile of Dupixent observed in children and adolescents was consistent with that seen in adults with atopic dermatitis. For full details please consult SmPC. Legal Classification: POM. List Price UK: 4 week pack containing 2 x pre-filled syringes or pens: £1,264.89. IE: Price on application. Marketing Authorisation Holder: Sanofi-Aventis groupe – 54, rue La Boétie, 75008 Paris, France. Marketing Authorisation Numbers: 2 x 200 mg pre-filled syringe: EU/1/17/1229/010; 2 x 300 mg pre-filled syringe: EU/1/17/1229/006. 2 x 200 mg pre-filled pen: EU/1/17/1229/014; 2 x 300 mg prefilled pen: EU/1/17/1229/018. Further information is available from: UK: Medical Information, Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. uk- medicalinformation@sanofi.com. IE: Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com. Date of preparation: December 2020.

Adverse events should be reported.

Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adverse events should also be reported to the Sanofi drug safety department on Tel: 0800 0902 314. Alternatively, send via email to UK-drugsafety@sanofi.com In Ireland: www.hpra.ie email: medsafety@hpra.ie Adverse events should also be reported to Sanofi Ireland Ltd. Tel: 01 403 5600. Alternatively, send via email to IEPharmacovigilance@sanofi.com

AD, atopic dermatitis; IL, interleukin.

References: 1. DUPIXENT Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/8553/smpc. Date accessed: January 2021. 2. Gandhi NA, et al. Nature Rev Drug. Disc 2016;15:35–50.

3. Blauvelt A, et al. Lancet. 2017;389:2287–2303. 4. de Bruin-Weller M et al. Clinically Meaningful Responses in Moderate-to-Severe Atopic Dermatitis Patients Treated with Dupilumab (Presentation) presented at the 27th European Academy of Dermatology and Venereology Congress, Paris, France, September 12–16 2018. 5. Simpson EL, et al. JAMA Dermatol. 2020;156(1):44–56. 6. Paller AS, et al. Am J Clin Dermatol. 2020;21:119–131.

7. Paller AS, et al. J Am Acad Dermatol. 2020;83(5):1282–1293. 8. Sanofi Data on File. MAT-GB-2005006 (v1.0).

Sanofi and Regeneron are collaborating in a global development programme and commercialisation for Dupixent.

Copyright © 2021 Genzyme Therapeutics Limited. All rights reserved.

MAT-IE-2001477(v1.0) | Date of preparation: February 2021

TARGETED CONTROL 1

Product FOCUS

Fludroxycortide Tape: A versatile, well-tolerated treatment option Sara Burr Fludroxycortide Tape has been used for more than 50 years and is a versatile and well-tolerated addition to the clinician’s suite of treatments, particularly regarding the treatment of chronic, localised, recalcitrant dermatoses. This article considers indications for use, application, and the patient experience.

Burr S. Fludroxycortide Tape: A versatile, well-tolerated treatment option. Dermatological Nursing 2021. 20(2):23-26

   

Introduction Chronic inflammatory skin conditions, including eczema, are common within primary, community and secondary care and are initially managed with emollients and topical medicinal products, including topical corticosteroids. The severity of the condition will determine how well the condition can be managed within primary care, and increased disease severity may require secondary care assessment and treatment.

This article will focus on the management of isolated or solitary patches of subacute and chronic eczema, but will also mention other dry and scaling dermatoses, where the use of a tape impregnated with the steroid fludroxycortide can be beneficial.

What is Fludroxycortide Tape?

Fludroxycortide Tape is a licensed product for use on chronic, localised, Sara Burr is a Community Dermatology Specialist Nurse Clinical Lead Community Skin Integrity Team. Norfolk Community Health and Care Trust. www.bdng.org.uk

recalcitrant dermatoses that may not respond to less potent topical corticosteroids.

It is a translucent polythene adhesive, waterproof film, impregnated with fludroxycortide (moderately potent steroid) (4μg/cm2) and protected by a removable paper liner. It provides the dual effect of topical steroid application/ absorption, plus occlusion (covering, providing optimum absorption potential).

Where patients have patches of chronic inflamed skin, this tape may be a helpful way of ensuring topical steroid absorption on sites that otherwise steroid is easily wiped/rubbed off.

Clinical indications

Other conditions include the following, as outlined by Dr Layton’s case study of Fludroxycortide Tape.4

Other conditions Many other conditions, such as overgranulation and keloid scars, have been helped with the use of this tape, and case studies illustrating some of these can be found on the Typharm website.3

Lichen simplex (see Table 1) represents a chronic inflammatory condition usually caused by repeated scratching/rubbing an itchy area of skin.

Fingertip fissures can represent a very painful and debilitating disorder, especially for those using their hands in everyday occupations.

These may have been worsened due to excessive hand washing or sanitising during the COVID-19 pandemic. The underlying cause may relate to eczema or psoriasis.

Some observations were made that nail dystrophy from eczema or psoriasis was also helped with nightly application for 4-6 weeks (see case study on website).3

Eczema It is well recognised that skin conditions such as eczema are usually long-term and follow a relapsing pattern. Eczema can present with different features which will determine if it is acute (red, inflamed with discomfort and pruritus), sub-acute (red/pink, erosions, vesicles, and pruritus) or chronic (mildly inflamed, dry and scaling with fissures and lichenification).1 More details regarding the presentation and symptoms of eczema can be found in Table 1.

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Product FOCUS Nodular prurigo characterised by extremely pruritic papules/ nodules, usually on the trunk and extremities.

Psoriasis, when used to treat discreet, nummular plaques.

Lichen planus, particularly if hypertrophic areas present.

Hand and foot eczema (see Table 1).

Discoid/nummular eczema (see Table 1).

Granuloma Annulare, sometimes seen as curative.3 Excessive granulation tissue within or around the edge of ulcers can occur in any context of healing venous or mixed varicose/ischaemic ulcers. The granulation tissue can become very vascular and bleed and may prevent healing. An application of Fludroxycortide Tape to the granulation tissue, once to twice weekly, alongside the usual dressings for six to eight weeks or daily for up to eight applications, can help reduce the granulation tissue. 5

Management of eczema The National Institute for Health and Care Excellence,6 The National Eczema Society,7 and the Primary Care Dermatology Society8 all recommend a stepped approach for the management of eczema, tailoring treatment to the severity of the eczema, as outlined below. This article will not discuss the full assessment of eczema and other management strategies (such as avoidance of soap, clothing/washing options etc), but the two main considerations are: Moisturising products (emollients): These provide the mainstay of management for eczema. They must be applied generously and frequently to help reduce itching, protect the skin from irritants and prevent the skin from drying out.

Further information can be gained from local emollient formularies, the BNF9 or National Eczema Society.6 Topical corticosteroids (first line): When eczema is inflamed, red, irritated, and itchy, topical steroids such as creams or ointments (or lotions for scalps) should be used.

There are four strengths of steroid 24

– mild, moderate, potent, and very potent. Potency use will depend on body site and severity of the eczema e.g., facial/genital eczema requires mild/moderate potency, whereas palms/soles may need very potent, and these discussions should be had with the prescriber.

Fingertip units (FTU) are a guide to the amount to use. For example, one fingertip full of steroid, from the fingertip to first crease of finger (or 1/3 finger), is enough to cover the amount of eczema measured by two flat palms. An adult may need up to seven fingertip units to cover their trunk area if extensive.10 The aim is for a period of use to settle the eczema and then step down the frequency, e.g., daily for seven days, then three times a week, twice a week, before stopping.11,12 It may be that the disease presentation, body site and lifestyle mean that the use of steroid creams

and ointments are prohibitive. This is where Fludroxycortide, moderately potent steroid, impregnated tape could be a helpful addition to the treatment regime.

Using Fludroxycortide Tape The tape is highly flexible, which makes it easy to apply to different body sites and can be appropriate for several different dermatological conditions.

Chronic and sub-acute dry and inflammatory conditions, where the skin is not wet, is the best condition for using the tape. If the skin is wet, the tape will not stick, so is not appropriate for moist intertriginous areas like the axillaei, groins or apron folds.

Is it easy to apply?

It is ideal to use on dry, localised skin irritation, with better adherence in hair free sites. Due to the adhesive and flexible nature of the tape, it can be used on joints such as elbows, knees, and digit tips.

Table 1.

Presentation and symptoms of eczema.2 Pruritus/itching E czematous eruption with inflammation, redness, possibly vesicles (small blisters) Dryness and scaling Tendency toward “sensitive” skin Personal history of asthma or allergic rhinitis and onset of eczema as a child

Major features

Types of eczema in adulthood

Asteatotic eczema – “crazy paving appearance”, exacerbated by low humidity and central heating Eczematous drug eruptions – so drug history is vital Varicose (also known as gravitational, stasis or Venous eczema on lower leg due to venous hypertension) Lichen simplex – also known as neurodermatitis, resulting from stress/habit causing thick skin due to repeated scratching Atopic – reoccurrence of childhood eczema, maybe with asthma and hay fever Contact dermatitis – irritant or allergic response where skin is repeatedly exposed to external allergen e.g., fragrance, nickel, hair dyes Discoid/nummular – well demarcated round/disc-shaped patches, often on trunk and limbs Seborrhoeic – in response to a yeast on the skin, usually on the face/nasolabial folds/eyebrows/ groin/armpits/skin folds, with greasy looking scale Photosensitive – response to sunlight with or without aggravation from chemicals in contact with sunlight e.g., fragrances Pompholyx – blistering eczema on hands and feet, can be triggered by contact dermatitis response to allergen Hand eczema – dry, red, itching palms and back of hands with cracking and soreness, either irritant or contact allergic origins

Types of eczema in bold indicate the ones amenable to treatment with Fludroxycortide Tape, as will be outlined later.

Dermatological Nursing, 2021, Vol 20, No 2

www.bdng.org.uk

Product FOCUS Practical aspects involved in application of the Fludroxycortide Tape include the following: 1. The skin must be clean, dry, and shorn of hair, free of excess exudate, crusts or scales prior to application.

2. The tape should be cut to the desired length and should cover a margin of a few millimetres of normal skin. It comes on a roll of either 20cm x 7.5cm (£12.49) or 50cm x 7.5cm (£18.75) long.

It comes in a container, where it should be kept once the required length has been cut.

3. The skin should be under gentle tension when the tape is applied.

The edges should be pressed down to produce tight, closed adhesion.

4. For adults and the elderly, the tape may be left in situ for 12 out of every 24 hours and can be left on overnight. All of the steroid is released after 12 hours.13 5. The tape can be covered with cosmetic camouflage and makeup, as well as emollients. It is also waterproof, so can be washed over.

There is no defined maximum quantity of tape that can be used.

However, it should be highlighted that when applied to large areas of broken skin, corticosteroids may be absorbed into the bloodstream.

Patients using large quantities of tape or other topical steroid cream/ointment should be evaluated periodically for evidence of hypothalamic pituitary adrenal axis suppression.12 It can be used for children, provided courses are limited to five days, and adults if results and progress of the condition are monitored.13 The adhesive is a mixture of acrylic acid and acrylate esters on a plastic backing. No colophony, rosin or latex are in the product which is important to consider when reassuring eczematous patients with possible allergic sensitivities.

The Fludroxycortide Tape comes in a carton box which hosts the patient leaflet and the round plastic container www.bdng.org.uk

with the roll of tape inside. All packaging is recyclable.

Is Fludroxycortide Tape cost effective?

A direct cost comparison to other topical corticosteroid plasters or tapes is not appropriate as the potency of steroid within the Fludroxycortide Tape (moderately potent) and other such plasters (potent) differs, while clinical indications may also differ.

A similar caution is highlighted when directly comparing Fludroxycortide Tape to other topical corticosteroids such as creams and ointments. Because of the fixed dosage found within the Tape and the high patient compliance,

Fludroxycortide Tape is uniquely placed within this sphere of treatment. There are very minimal risks of over- or underdosing since there is no need to rely on the patient to apply the correct amount of steroid onto their skin.

Furthermore, Fludroxycortide Tape provides additional benefits when considering the product’s unique characteristics, such as it being waterproof and the possibility of applying make-up over it, for those patients concerned with how their skin conditions appear.

The patient experience There is no recent large cohort research or trial data looking specifically at patient

Dermatological Nursing, 2021, Vol 20, No 2

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Product FOCUS experiences of using this tape. However, the case studies and reviews available on the Typharm website, written by various medical professionals, illustrate the clinical response of patients with various conditions, to the use of the tape on their skin.2

Fludroxycortide Tape appears to be a welltolerated, convenient occlusive treatment option for a variety of chronic/subacute cutaneous problems Other steroid impregnated products Although Fludroxycortide Tape is the only steroid impregnated tape currently on the market, there are steroid impregnated plasters that can be used to manage isolated patches of eczematous/ inflamed skin. The unique properties of Fludroxycortide Tape, such as being waterproof and that it can be cut to any size or shape (due to its roll presentation), ensures it is a distinct alternative for the treatment of various skin concerns.2 Undesirable and adverse effects Patients occasionally complain of eczematous adverse reactions, folliculitis (particularly in adjoining skin), and the excessive de-scaling of plaques with slight bleeding in psoriasis. The incidence of local atrophy or striae appears to be rare, particularly if the tape is just used overnight for periods of up to four weeks at a time and avoiding prolonged use.

The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, miliaria, striae and thinning, and dilatations of superficial blood vessels producing telangiectasia.

26

Conclusion Eczematous, inflammatory, and proliferative skin conditions are common within both primary and secondary care. Standard treatments involve the use of topical therapies with emollients and topical corticosteroids.

Sometimes the application of cream or ointment-based preparations are sufficient to control the condition, however there are times when persistent patches within these conditions, as outlined in this article, are less responsive to that formulation.

Fludroxycortide Tape appears to be a well-tolerated, convenient, occlusive treatment option for a variety of chronic/sub-acute cutaneous problems that may have failed to respond to lower potency topical corticosteroids, tar preparations and/or emollients and is available on prescription (FP10 and GP10 (Scotland) for use by clinicians who identify where it may be helpful.

In addition to its unique benefits, such as being waterproof, the tape allows for once daily application, enhanced hydration, and protection of the skin problems, as well as a more accurately measured dose of corticosteroid.

www.pcds.org.uk/clinical-guidance/eczema-handdermatitis#images [last accessed June 21] 2. Walling HW, Swick BL, Update on the management of chronic eczema: new approaches and emerging treatment options. Clin Cosmet Investig Dermatol 2010. 3:99-117 3. Typharm. Fludroxycortide Tape 2021.

Available at: https://www.typharm.com/products/ fludroxycortide-tape/ [last accessed June 2021] 4. Layton A. Reviewing the use of Fludroxycortide tape (Haelen Tape in Dermatology Prac-tice. Typharm 2006. Available at: https://www. typharm.com/products/fludroxycortide-tape/ [last accessed June 2021] 5. McGrath A. Overcoming the challenge of overgranulation. Wounds UK 2011. 7(1): 42-49 6. National Institute for Health and Care Institute, Atopic eczema in under 12s: diagnosis and management 2007. Available at: https:// www.nice.org.uk/guidance/CG57/chapter/1Guidance#treatment [last accessed June 2021] 7. National Eczema Society. Types of eczema 2021.

Available at: https://eczema.org/information-andadvice/types-of-eczema/ [last accessed June 2021] 8. Primary Care Dermatology Society. Eczema – Atopic Eczema 2019. Available at: http://www. pcds.org.uk/clinical-guidance/atopic-eczema [last accessed June 2021] 9. BNF British National Formulary. 2021.

Available at: https://about.medicinescomplete.com/ publication/british-national-formulary/ [last accessed June 2021] 10. Long C & Finlay AY (1991), The Fingertip-unit - a new practical measure. Clinical and Experimental Dermatology, 16: 444-447

Further useful educational tools for health professionals and patients are available online at www.typharm.com/ tape, including an application video and a cutting template amongst others. DN

11. NCBI 2017 https://www.ncbi.nlm.nih.gov/ books/NBK424899/ 2017 Eczema: Steroids and other topical medications, accessed 08.05.21

References

13. Typharm 2021 Summary of product characteristics accessed 8.5.21 https://www. typharm.com/wp-content/uploads/2020/06/ukspc_16_04_21.pdf

1. Primary Care Dermatology Society. Hand (and foot eczema) 2019. Available at: http://

Dermatological Nursing, 2021, Vol 20, No 2

12. NICE 2021 accessed 8.5.21 https://cks.nice.org. uk/topics/eczema-atopic/prescribing-information/ topical-corticosteroids/

www.bdng.org.uk

A simple oral choice for your patients with less severe plaque psoriasis OTEZLA® (apremilast) 10mg, 20mg and 30mg film coated-tablets Prescribing Information Refer to the Summary of Product Characteristics (SPC) before prescribing Presentation: 10mg, 20mg and 30mg film coated-tablets.

Indications: Psoriatic arthritis: Alone, or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), for active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to prior DMARD therapy. Psoriasis: Moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).

Dosage and administration: Treatment should be initiated by specialists experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis. The recommended dose is 30mg twice daily taken orally in the AM and PM, approximately 12 hours apart, with no food restrictions. The tablets should be swallowed whole. An initial dose titration is required: Day 1: 10mg AM; Day 2: 10mg AM, 10 mg PM; Day 3: 10mg AM, 20mg PM; Day 4: 20mg AM, 20mg PM; Day 5: 20mg AM, 30mg PM; Day 6 and thereafter: 30mg twice daily AM and PM. No re-titration is required after initial titration. If patients miss a dose, the next dose should be taken as soon as possible. If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time.

Patients with severe renal impairment: Reduce the dose to 30mg once daily in patients creatinine clearance of less than 30mL per minute. For initial dose titration in this group, titrate using only the AM doses. Paediatric population: Safety and efficacy in children up to 17 years have not been established. No data available.

Contraindications: Hypersensitivity to the active substance(s) or to any of the excipients, pregnancy.

Pregnancy should be excluded before treatment can be initiated.

Special warnings and precautions: Diarrhoea, nausea and vomiting: Severe diarrhoea, nausea, and vomiting have been reported. Most events occurred within the first few weeks of treatment. Some patients were hospitalised. Patients 65 years of age or older may be at a higher risk of complications. Discontinuation of treatment may be necessary. Psychiatric disorders: Increased risk of psychiatric disorders such as insomnia and depression. Instances of suicidal ideation and behaviour, including suicide, have been observed. Assess the risks and benefits of starting or continuing treatment if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended. Instruct patients and caregivers to notify the prescriber of changes in behaviour or mood and suicidal ideation. Discontinue treatment if patients have new or worsening psychiatric symptoms, suicidal ideation or suicidal attempt. Severe renal impairment: see dosage and administration. Underweight patients: May cause weight loss. Monitor body weight regularly in patients who are underweight at the start of treatment. Evaluate patients who have unexplained and clinically significant weight loss, and consider discontinuing treatment. Lactose content: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Interactions: Co-administration of strong cytochrome P450 3A4 (CYP3A4) enzyme inducer, rifampicin, resulted in a reduction of systemic exposure of Otezla, which may result in a loss of efficacy. Concomitant use of strong CYP3A4 enzyme inducers e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, St. John’s Wort

is not recommended. In clinical studies, Otezla has been administered concomitantly with topical therapy (including corticosteroids, coal tar shampoo and salicylic acid scalp preparations) and UVB phototherapy.

Can be co-administered with a potent CYP3A4 inhibitor such as ketoconazole, and methotrexate in psoriatic arthritis and with oral contraceptives.

Pregnancy, lactation and fertility: Women of childbearing potential should use an effective method of contraception to prevent pregnancy during treatment. Do not use during breast-feeding. No fertility data are available in humans.

Undesirable effects: Psychiatric disorders: In clinical studies and post-marketing experience, uncommon cases of suicidal ideation and behaviour were reported, while completed suicide was reported post-marketing.

The most commonly reported adverse reactions are gastrointestinal (GI) disorders including diarrhoea (15.7%) and nausea (13.9%). GI adverse reactions generally occur within the first 2 weeks of treatment and usually resolve within 4 weeks.

Adverse reactions reported in the psoriatic arthritis and/or psoriasis clinical trial programme and post marketing experience include: very common (≥ 1/10) diarrhoea*, nausea*; common (≥1/100 to <1/10) bronchitis, upper respiratory tract infection, nasopharyngitis*, decreased appetite*, insomnia, depression, migraine*, tension headache*, headache*, cough, vomiting*, dyspepsia, frequent bowel movements, upper abdominal pain*, gastroesophageal reflux disease, back pain*, fatigue; uncommon (≥1/1,000 to <1/100) hypersensitivity, suicidal ideation and behaviour, gastrointestinal haemorrhage, rash, urticaria, weight loss; not known (cannot be estimated from the available data) angioedema. *At least one was reported as serious.

Please consult the SPC for a full description.

Pharmaceutical Precautions: Do not store above 30°C. Legal category: POM. Basic Costs, Presentation and Marketing Authorisation Numbers Great Britain (GB): Initiation pack (4 x 10mg, 4 x 20mg, 19 x 30mg), 27= £265.18 – PLGB 13832/0047; 30mg tablet, 56= £550 PLGB 13832/0048. Marketing Authorisation Holder GB: Amgen Limited, 216 Cambridge Science Park, Milton Road, Cambridge, CB4 0WA, UK. Basic Costs, Presentation and Marketing Authorisation Numbers Northern Ireland (XI): Initiation pack (4 x 10mg, 4 x 20mg, 19 x 30mg), 27= £265.18 – EU/1/14/981/001; 30mg tablet, 56= £550 – EU/1/14/981/002.

Marketing Authorisation Holder XI: Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, The Netherlands.

Further information is available from Amgen Limited, 216 Cambridge Science Park, Milton Road, Cambridge, CB4 0WA, UK. Otezla is a trademark owned or licensed by Amgen Inc., its subsidiaries, or affiliates.

Date of preparation: May 2021 (Ref: GB-OTZ-0421-00016).

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk.

Adverse events should also be reported to Amgen Limited on +44 (0) 1223 436441 OTEZLA® is a trademark owned or licensed by Amgen Inc., its subsidiaries, or affiliates.

Date of preparation: May 2021

GB-OTZ-0521-00006

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Research SKILLS

Cultural nuances of skin shame:

A qualitative study of skin conditions in Chinese women living in the UK Erica Lam, Andrew Thompson Abstract Background: Qualitative studies demonstrate that some people living with a skin condition report stigmatisation. However, little is known about the experience of stigmatisation of living with a skin condition from the perspective of individuals of Chinese ethnicity.

Aims: This study examined the experience of Chinese women living in the UK with a skin condition, and detailed their experience of adjustment, treatment, and the reactions of others.

Methods: The study used the qualitative method of Interpretative Phenomenological Analysis. Semi-structured interviews were conducted with 10 Chinese women living with a range of skin conditions. The rigor of the analysis was ascertained via a process of secondary audit.

Results: Participants described themes related to (1) early naming and identification of the skin condition as shameful; (2) cultural views on the acceptability of concern about appearance; (3) shame and self-disgust internalised from the reactions of others; (4) adjustment taking place via reappraisal of other people’s reactions and the personal value placed on appearance; and (5) treatment potentially being all consuming. The findings contain unique reference to subtle differences found between participants of a British-born-Chinese heritage and participants from Asia. These differences relate to disparities in how the self is constructed and how this influences experience of self-conscious emotions.

Conclusions: The findings present an in-depth account of British Chinese women’s experience of living with a skin condition.

They support findings from other studies that skin conditions can be stigmatising and result in feelings of shame. This study demonstrates how the experience is also influenced by differences that may arise between “individualistic” and “collectivistic” cultures.

The findings indicate the importance of conducting holistic culturally sensitive assessments.

Lam E, Thompson A. Cultural nuances of skin shame: A qualitative study of skin conditions in Chinese women living in the UK. Dermatological Nursing 2021. 20(2):29-33

People living with a visible skin condition may experience intrusive reactions from others, such as staring and name-calling,1 and may be subject to stigmatisation2-5.

Existing qualitative studies have illustrated that, whilst stigmatisation is commonly reported in skin conditions, the impact of this may be different across countries.6, 7 For example, Thompson et al.6 found that British South Asian women living with vitiligo commonly engaged in avoidance and concealment, which has also been reported in other populations. However, they also found that experiences of stigmatisation were tied up with cultural values related to the role appearance plays in status, marriageability, and to myths associated with the cause of the condition.

Understanding such factors may be useful in developing psycho-educational

     Declaration of interest: None Dr Erica Lam is Consultant Clinical Psychologist, Aspire Therapeutic Services Ltd, George Town, Grand Cayman. Professor Andrew Thompson* Programme Director, Consultant Clinical Psychologist, South Wales Clinical Psychology Training, Cardiff University 11th Floor, Tower Building, 70 Park Place Cardiff, CF10 3A. *Corresponding author

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Research SKILLS interventions and in facilitating adherence to dermatological treatment.

There remain few studies that have examined socio-cultural factors associated with adjustment in skin conditions, and none that have examined this in Chinese communities (living in China or elsewhere). This is additionally problematic as there is evidence that skin conditions present a considerable healthcare burden in China, where conditions such as scabies and dermatitis may be particularly prevalent8. Further, it has been established that there may be differences related to “individualistic” and “collectivistic” cultural values in relation to experiences of shame, which might play out in experiences of skin related stigmatisation.9 Consequently, this study sought to explore the experience of women of Chinese ethnic backgrounds in the UK who were living with a recognised skin condition. The aim was to understand their personal experience, their experience of treatment, and how their experiences might be shaped by sociocultural factors.

Method The qualitative method of Interpretative Phenomenological Analysis (IPA)10 was used because it has been specifically developed to focus on lived experience, whilst acknowledging that there is a process of interpretation on the part of the researcher involved. IPA is deliberately idiographic and looks at accounts derived from small numbers of participants taking a case-by-case approach. IPA has previously been successfully used to explore the experience of living with specific skin conditions.11 Participants Ethical approval was gained from the University of Sheffield, UK. Women diagnosed with a skin condition such as vitiligo, psoriasis, eczema, and acne, who identified themselves as Chinese and were over the age of 18 years old were recruited. Ten female participants from Chinese communities within the UK were recruited via the National Eczema Society and via university volunteer lists.

30

The participants ranged in age from 22 to 42 (mean= 28, SD= 7) and were from various parts of the UK. All had a skin condition for more than eight years.

Participants described themselves as British-Born-Chinese (n=3) or Chineseliving-in-the-UK (n=7).

Data collection Semi-structured interviews were conducted by the first author, in either English, Cantonese, or Mandarin depending on participant preference.

To ensure cultural sensitivity, the interview schedule was developed in collaboration with a community advisory panel.12 The interviews focused on eliciting information on: (a) personal experience, (b) reaction of others, and (c) treatment experience. Interviews lasted approximately 60 minutes and were recorded and transcribed verbatim.

Data analysis and interpretation The transcripts were analysed in accordance with principles of IPA.13, 14 Transcripts were read several times alongside the audio-track to check for accuracy and to assist with engaging with the data. Initial responses to the data were recorded and then the transcripts were re-read. Preliminary themes were identified and analysed line-by-line from linguistic, descriptive, and conceptual perspectives.14 Emerging themes were identified that captured the meaning of the data and the researcher’s interpretation of it. These themes were then further developed and restructured hierarchically to develop a list of super-ordinate themes. Connections between themes were then developed within and between participants using pictorial representation to facilitate interpretation. Final themes were checked against the original transcripts to ensure that the context from which they were taken was not lost during analysis. Several established strategies were used to enhance the rigour of the findings, including an audit of the analysis process.13

different, to detailed accounts of life with a long-term condition and the experiences of treatment and support.

Whilst the accounts of living with a skin condition were described in a temporal order (partially as an artefact of the interview schedule), the psychological processes involved were not linear and the participants’ accounts contained references to unique cultural factors with subtle differences evident between participants who described themselves as British-Born-Chinese (BBC) and those that described themselves as Asian (international students).

Theme 1: Shame can be embedded in the name of the conditions The literal translation of some conditions was bound up with the meaning participants gave to the condition and consequently to the impact of it.

P6 (has psoriasis): ‘...They describe it in Chinese (牛皮屑, psoriasis) it is like (牛皮, cow’s skin), the skin of the cow, it’s very thick and very hard and so you… will feel it is very horrible.’

The diagnosis and associated meaning of the term in Chinese clearly contributed to a sense of self-disgust, a feeling of being dehumanised and becoming ‘animal-like’. Some participants also talked about their skin condition as ‘an enemy’ which ‘creeps up on you’ (P7, has eczema); and some even feared it being seen to be caused by a ‘sexually transmitted disease’ (P2, has eczema).

Theme 2: Secondary shame associated with being seen to be vain Cultural views about appearance and the unacceptability of being seen to be overly concerned with appearance, and thus vain, were reported. This appeared to influence participants’ views of themselves and ran the risk of influencing adherence to treatment.

Results

P6 (has psoriasis): ‘…If I’m at home I just, scratch it directly but if I’m in a public place I would, tolerate it… it’s not good manners to [scratch].’

The themes are presented in temporal order that show commonalities across different conditions – from the discovery of the condition and to feeling

The quote demonstrates the importance of collectivist concepts and the importance of being seen to behave

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Research SKILLS with good manners, mindful of others, without overly focusing on one’s own body. This was more prevalent in the international student participants.

Being the ‘only Chinese’ child in the school may have heightened their sensitivity to prejudice, making the experience of having a skin condition more stigmatising.

Theme 3: Shame and self-disgust internalised from the reactions of others Participants described experiencing negative social reactions such as staring, teasing, and bullying, as has been found across other cultures.

Not wanting to be different, participants engaged in concealment or avoided social situations and intimate relationships for fear of being rejected.

P1 (has eczema): ‘I think the worst situation where it’s ever been noticed where I cried ...I was seven ...they stopped me from going into the swimming pool because they were worried that my skin was contagious.’

P10 (has vitiligo): ‘Because I can cover mine by clothes so nobody know it, only when I tell people… your appearance I think is more important, especially when I worked as a secretary I think, so I worry if one day it will spread to my face, I don’t think the company will employ me.’

It is not surprising that such stigmatising experiences were reported as causing distress and occasionally shame.

P3 (has psoriasis): ‘I still feel ashamed, I feel kind of conscious of people learning that I have psoriasis because I think they’re going to think badly about me or, you know, it’s a flaw isn’t it… I felt disgusting, I know that sounds a bit harsh but I, literally I felt disgusting… in my head when I say I’m thinking, God you know, that’s quite vain.’

This quote was typical of participants’ fears of receiving negative evaluation from others in connection with their appearance and a secondary sense of self-disgust or shame associated with being overly concerned with the self.

Participants described themselves as being different due to their skin condition. Being an ethnic minority group living in the UK, they described feeling doubly different; and this was particularly the case for participants born in the UK, some of whom had experienced racial abuse, making their experience of feeling different due to their skin condition more difficult.

P1 (has eczema): ‘The only Chinese girl in an all white school you really have enough that makes you stand out, erm, you don’t want something else that makes you stand out so I had two huge things that made me stand out, the fact that I was the only Chinese girl in the whole school and the fact that I had eczema.’ www.bdng.org.uk

Theme 4: Adjustment via reappraisal of others reactions and the personal value of appearance Cognitive strategies and behavioural management styles were commonly described. Despite facing very real risk of receiving negative reactions from others, one of the commonly described cognitive strategies was recognition (and thus correction) of a tendency to over-estimate the chances of encountering negative social reactions.

P3 (has psoriasis): ‘I think what’s in your head is always so much worse than, you know, you invent things in your head when people look at you, you know, they, they could be looking at you for any reason, they’re not necessarily looking, I mean when somebody, when I see somebody who has a skin condition I’ll look at it but then that’s it, I won’t keep, and it’s very difficult to think well when I do that I’m not judging anyone.’

Participants reported having revised the value they placed on appearance in their self-concept and reported that by putting less attention on appearance they were no longer in conflict with their physical symptoms, rather they sought to seek harmony between their mind and body. This in turn facilitated engagement in culturally derived methods of maintaining wider health: P1 (has eczema): ‘Now my parents are making me soup because it’s good for me not to get rid of [it]… ’

Emphasis for many participants was placed on establishing a healthy balance in life to prevent flares, which were linked to traditional Chinese understanding of wellbeing. However, some participants felt that it was an extra burden to maintain this.

P3 (has psoriasis): ‘I was living life at a ridiculously fast pace… it was only when I stopped to have that treatment (acupuncture) twice a week I realised… I realised that that’s what I’ve got to start doing for myself, I need to have that time out… I need to slow down… I’ve learnt a bit about meditation and yoga…’

Overall, acceptance of self with the skin condition was linked to feelings of acceptance by friends and family.

P1 (has eczema): ‘As you grow up older and older, and also become more accepting in your, you develop friendship groups, close friendship groups, you realise that they don’t care, and as I sort of settled into my friendship groups… the impact of having eczema has been less…’

Theme 5: Treatment can be all-consuming Seeking treatment and advice on management of symptoms was reported as occupying a large part of the participants’ lives, and social network support, where people share similar experiences, was popular and balanced with seeking medical and traditional support. Participants described a sense of willingness to try anything that was perceived to be helpful despite also being sceptical. UKborn participants, who had experience of Western medicine, expressed scepticism about traditional treatments such as acupuncture and Chinese remedies, yet they were willing to try them. They reported that their engagement with traditionally derived treatments was motivated in part by desire to avoid family confrontation.

P1 (has eczema): ‘I think my parents bathe me pretty much everything… the carrot is that you’re getting rid of eczema so as disgusting as it was, you just do it, my grandmother would hold my nose and I would just down it (herbal

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Research SKILLS medicine) all in one… I think any Chinese child would as well, you just do what your grandmother says.’

Dietary manipulation and restriction formed a part of the alternative treatment; however, this practice sometimes clashed with cultural concepts of the importance of eating what you are offered.

P7 (has eczema): ‘When we are eating stuff they will say, oh why don’t you eat beef or why you don’t eat prawns? And they will just keep questioning you and trying to force you to eat… I struggle because people give it to you and should I eat or not… because in Chinese culture you would…’

The participants described other differences between Western medical models and Chinese beliefs. The Eastern medical model believes in organ function and the Yin-Yang principle; any symptoms of skin condition are seen as a sign of imbalance between Yin (陰) and Yang (陽) forces in the body, and the person’s body, mind and spirit are treated as a whole to restore equilibrium. Hence, the diagnosis leads to a series of treatments aimed at achieving balance. The differences in conceptualisation of health had an impact on how the participants viewed their condition or how they chose to live with it. For example, the participants of international origin focused on seeking balance within their bodies. For them, there was great importance attached to the concept of detox (cleansing of the inner organs) or ‘getting rid of the heat’ by adherence to a specific diet or remedy.

P4 (has acne and eczema): ‘… It reminds me to think about what is the best, what is the most healthy lifestyle and I realise that I have to eat healthy food and drink water as many times a day to 排毒 (detox) just the Chinese concept, my mum would say don’t eat beef 燥熱 (it carries heat).’

Some participants felt responsible for their skin condition as the Chinese medical model implied that skin disease resulted from lifestyle issues.

32

P4 (has acne and eczema): ‘They said “it is just because you have some problem with your organs it will affect your face’’… so I just like pay attention to not sleeping too late, not eating hot and spicy food.’

P5 (has acne): ‘…In China they would say that there is a heat in your body, and it revealed on your face, like different areas on your face, present different problems with your organs in your body.’

Another cultural difference was described in the meaning of treatment.

For example, participants described the process of preparing herbal remedies as serving to bring the family closer together.

P1 (has eczema): ‘…They’re convinced it’s something about the heat inside me, getting rid of it…making soup… I’m in my thirties, he’s (father) sixty and he still does it for me.’

Discussion This study found that aspects of the experience of living with a skin condition – such as feeling different and struggling with a fear of negative evaluation – to be similar to those in previous studies, which further highlights the common psychosocial difficulties people living with skin conditions may face,11,13,15-18 and the relevance to models of shame, stigma, and social anxiety. 5 This adds weight to the suggestion that cognitive behavioural therapies may be useful in treating some of the distress associated with appearance concern linked to selfdisgust and body image disturbance. 5 Whilst there were similarities with the existing literature, culturally specific factors unique to the sample of Chinese women were found which may be overlooked in clinical practice.

Thompson et al.6 also found subtle differences in the way that stigmatisation might operate in their sample of British South Asian women. The women in this study did not make direct reference to their condition influencing marriage or status as reported by Thompson et al., however, the findings of the current study demonstrate that participants concern about the meaning of the skin condition were influenced by cultural

Dermatological Nursing, 2021, Vol 20, No 2

values and wider concepts of wellbeing derived from Eastern cultures.

Most interviews illustrated participants’ experiences of being stigmatised due to their skin condition, but also a fear of being seen as vain if they became overly concerned with the condition. The emphasis on collectivism within Chinese culture may provide some explanation as to why dietary habits and behaviours such as scratching presented an additional challenge for participants. Interestingly, the translations of some diagnoses were also influential in stigmatisation as they linked conditions to animal traits.

The current study illustrated that cultural differences were associated with dilemmas around self-management.

Some of the participants described believing that Western medicine lacked a holistic and contextual view of skin disease, whilst others were sceptical about traditional remedies. Dilemmas in relation to cultural practices and healthcare have been found in other studies with Chinese women.9 This study demonstrates that the pursuit of treatment involves sensitive balancing between different belief systems, that in turn adds complexity to selfmanagement with the potential to influence adherence to prescribed treatments. Being aware of subtle cultural factors might be useful for clinicians in discussing engagement with treatment.

Clearly, these findings suggest some avenues for exploration when conducting holistic dermatology assessments, and healthcare professionals should look to ask about what it might ‘mean’ for a specific patient to be seen to be scratching or worrying about their appearance.

Where this meaning is associated with low levels of distress, simple reassurance may be sufficient; however, where higher levels of distress are present, referral for psychological support is indicated. It can also be useful to explore culturally based understandings of causation, as understanding these may present opportunities for patient education. Finally, it remains important www.bdng.org.uk

Research SKILLS to check for the need for support in managing actual discrimination that might be associated with both skin disease-related prejudice, and in some cases experiences of racial abuse.

There were some interesting inter-cultural differences between the participants based on whether they were born in the UK, although given the small sample size, some caution must be expressed in drawing conclusions from this. Further, this study acknowledges that as it sought to present a detailed idiographic account it is not generalisable, so further research with a larger, more homogenous sample of participants is required. Whilst this study does not allow wider generalisation to the Chinese population with skin conditions, it does serve to demonstrate some of the specific cultural factors that may impact on psychosocial adjustment and has demonstrated the complex relationship that exists between these and wellbeing. DN

References: 1. Schmid-Ott G, Schallmayer S, Calliess IT. Quality of life in patients with psoriasis and psoriasis arthritis with a special focus on stigmatization experience. Clin. Dermatol 2007. 25:547-54

2. Porter JR, Beuf AH. Racial variation in reaction to physical stigma - a study of degree of disturbance by vitiligo among black-and- white patients. J. Health Soc. Behav 1991. 32:192-204 3. Ginsburg IH, Link BG. Psychosocial consequences of rejection and stigma feelings in psoriasis patients. Int. J. Dermatol 1993. 32:587-91 4. Gupta MA, Gupta AK, Watteel GN. Perceived deprivation of social touch in psoriasis is associated with greater psychologic morbidity: An index of the stigma experience in dermatologic disorders. Cutis 1998. 61:339-42 5. Thompson A, Kent G. Adjusting to disfigurement: processes involved in dealing with being visibly different. Clin Psychol Rev 2001. 21:663 6. Thompson AR, Clarke SA, Newell RJ et al.

Vitiligo linked to stigmatization in British South Asian women: a qualitative study of the experiences of living with vitiligo. Br. J. Dermatol. 2010.

163:481-6 7. Wahl AK, Gjengedal E, Hanestad BR. The bodily suffering of living with severe psoriasis: In- depth interviews with 22 hospitalized patients with psoriasis. Qual. Health Res 2002. 12:250-61 8. Dong W, An J, Geng P et al. Years lost due to disability from skin diseases in China 1990-2017: findings from the global burden of disease study 2017. Br J Dermatol 2020. 182:248-250 9. Wong Y, Tsai JT. Cultural models of shame and guilt. In: The self-conscious emotions: Theory and Research (Tracey JL, Robins RW, Tangney JP, eds).

In. New York: Guildford Press. 2007; 209-23 10. Biggerstaff D, Thompson AR. Interpretative Phenomenological Analysis (IPA): A qualitative

methodology of choice in healthcare research.

Qual Res Psychol 2008. 5:214-24 11. Thompson AR, Kent G, Smith JA. Living with vitiligo: Dealing with difference. Br. J. Health Psychol. 2002. 7:213-25 12. Salway S, Hallmark P, Barley R, et al. Social research for a multiethnic society: exploration of current guidance and future possible directions.

In: 21st Century Society. 2009 13. Smith JA, Flowers P, Larkin M. Interpretative Phenomenological Analysis: Theory, Method and Research. London: Sage. 2009 14. Larkin M, Thompson A. Interpretative Phenomenological Analysis. In D Harper & A Thompson (Ed). Qualitative research methods in mental health and psychotherapy. An Introduction for students and practitioners. Oxford: Wiley.

2012.101-16 15. Borimnejad L, Parsa Yekta Z, NikbakhtNasrabadi A et al. Quality of life with vitiligo: Comparison of male and female Muslim patients in Iran. Gender Med 2006. 5: 124-30 16. Dures E, Morris M, Gleeson K et al. The Psychosocial Impact of Epidermolysis Bullosa.

Qual. Health Res 2011. 21: 771-82 17. Thompson, A. Researching Appearance: models, theories and frameworks. In: Rumsey N, Harcourt D, editors. Oxford Handbook of the Psychology of Appearance. In. Oxford, UK. Oxford University Press 2012.

18. Uttjek M, Nygren L, Stenberg B et al. Marked by visibility of psoriasis in everyday life. Qual.

Health Res 2007. 17: 364-72.

DERMATOLOGICAL NURSING

Call for papers Each year, the Dermatological Nursing Editorial Board actively seeks and encourages colleagues to write up their work and publish. As Clinical Editor, I support this and would like to highlight this call for papers.

Are you interested in having your work published?

Have you completed some work or project which enhances knowledge, skills or dermatology nursing?

Do you have a patient case study that would be of interest to our readership?

Have you recently completed an audit that has informed practice development or service delivery?

Have you recently completed a dissertation or a literature review?

Is there a particular clinical area that interests you and you wish to share?

Do you have a medical or nursing colleague who would like to write for publication?

If so, please consider submitting a paper to Dermatological Nursing.

Support and advice is available to guide you through the writing process, so please, do not hesitate to contact myself, Kathy, Rob or any member of the Editorial Board for advice. (Email addresses are listed in the journal).

Polly Buchanan Clinical Editor, BDNG Dermatological Nursing Journal www.bdng.org.uk

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33

The AbbVie Dermatology Medical Team of Nurse Consultants and Medical Science Liaisons in the UK runs a number of CPD-/RCNaccredited medical education programmes, which have been developed with leading Dermatologists and Dermatology Nurse Specialists.

Contact your Abbvie Dermatology Medical Team at dermdialogue@abbvie.com for more information.

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An engaging series on the pathophysiology and management of psoriasis

Holistic management and treatment of atopic dermatitis from the perspectives of both the patient and the medical team

A series of interactive modules with practical nurse guidance on the care of atopic dermatitis including disease assessment tools

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This medical education programme is developed and funded

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Dermatology Educational Sessions CPD & RCN accredited sessions.

This large range of educational sessions are tailored for: • Nurses new to managing psoriasis and atopic dermatitis • Experienced Dermatology Nurses who require updates on latest management of psoriasis and atopic dermatitis Interactive and engaging sessions led by your local Medical Science Liaison and Nurse Consultant at dates and times to suit you and your team.

Email dermdialogue@abbvie.com to arrange your educational sessions.

medical

AbbVie Pro Medical Visit medical.abbviepro.com to find out more information on our educational sessions and to listen to your UK Dermatology peers discussing the latest practical topics in the care of patients with atopic dermatitis and psoriasis in our podcast series.

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This medical education programme is developed and funded

by AbbVie Ltd for UK healthcare professionals only.

ABBV-UK-00212-FM | May 2021

Pharmacological OPINION

Clascoterone: A novel, first-inclass topical anti-androgen treatment for acne Rod Tucker

The Food and Drug Administration has recently approved the use of clascoterone for the treatment of acne vulgaris. This article looks at the use and mode of action of this topical anti-androgen, and considers where it will fit in the treatment regime if subsequent UK approval is granted.

Tucker R. Clascoterone: A novel, first-in-class topical anti-androgen treatment for acne. Dermatological Nursing 2021. 20(2):36-38

    

T

he latest topical acne treatment approved by the Food and Drug Administration (FDA) is Clascoterone, a first-in-class agent, which targets androgen receptors in the skin and is licensed for use in patients 12 years and over.

Acne vulgaris (or simply acne) is a chronic inflammatory skin condition that affects nearly 90% of teenagers.1 However, while largely perceived as a condition of adolescence, acne can and does persist into adulthood, with one self-reported survey of 744 individuals 20 years and older, finding that between the ages of 40 and 49, 26.3% of women and 12% of men still had the condition.2 Acne affects the pilosebaceous follicles,

Rod Tucker is a Pharmacist with a Special Interest in Dermatology, and a member of the Dermatological Nursing Editorial Board.

36

and although these are present on most areas of the skin, there is a much higher concentration in the T-zone of the face (i.e., forehead and cheeks), as well as the chest and back, which explains why acne predominately occurs in these areas. The condition is characterised by non-inflamed lesions (open and closed comedones), inflammatory papules and pustules, and in more severe cases, nodules and cysts.

While largely perceived as a condition of adolescence, acne can and does persist into adulthood Though the precise cause of acne remains unclear there are at least four factors that have been implicated in the pathophysiology: 1. Release of inflammatory mediators in the skin 2. An androgen-mediated increased production of altered sebum 3. Abnormal keratinocyte proliferation and differentiation (ductal hypercornification or comedogenesis) 4. Proliferation of the anaerobic, commensal organism Cutibacterium acnes (C. Acnes), within functionally blocked follicles.

Dermatological Nursing, 2021, Vol 20, No 2

The interplay between these factors in the development of acne remains to be full elucidated but the final blocked follicle is termed a microcomedone and is the earliest of acne lesions from which all of the other lesion types will develop.

Androgen synthesis occurs within the sebaceous glands in the skin and both testosterone and 5-∝-dihydrotestosterone (DHT), which is produced by the action of the enzyme 5-∝-reductase, are able to bind with cutaneous androgen receptors, although DHT is a more potent receptor agonist.3 While the precise role of androgens in acne remains to be determined, the efficacy of androgen receptor blockers such as spironolactone and cyproterone acetate, suggest an important role in the pathophysiology of acne.4

Clascoterone – mode of action Clascoterone, also known as Cortexolone 17-∝-propionate, is an androgen antagonist and while the precise mode of action is uncertain, in vitro work has revealed how the drug inhibits androgen-mediated lipid and inflammatory cytokine production from sebocytes, suggesting that it competes with DHT. 5 Once in the skin, hydrolysis of the propionate moiety produces the inactive parent compound cortexolone that has no systemic anti-androgenic effects.6 www.bdng.org.uk

Pharmacological OPINION Pre-clinical studies

Clinical studies

Although the parent compound, cortexolone, is likely to be systemically inactive, a phase 2 trial was undertaken to assess for evidence of adrenal suppression. In the trial, a 1% cream formulation was applied twice daily to the entire face, shoulders, upper chest and back of 42 patients with acne for a total of 14 days. Although three patients had abnormal hypothalamic-pituitary axis results, defined as a post-stimulation serum cortisol level <18 mcgs/dL, ranging from 14.9 to 17.7 mcg/dL at day 14, these changes normalised four weeks after discontinuation of the treatment.7

In acne clinical trials, one of the most commonly used tools to measure the success of a treatment is changes in the investigator’s global assessment (IGA) score, a five-point severity scale ranging from 0 (clear skin) to 4 (severe acne).8 The first randomised, doubleblind study of clascoterone compared the drug against both placebo and 0.05% tretinoin cream. In the study, 77 men all with a baseline IGA score of either 2 (mild) or 3 (moderate), were randomised to one of the three treatments and which were applied once daily for eight weeks. A treatment

% achieving a treatment success

25

20

15

10

5

18.4

9

20.3

6.5

Clascoterone (S1)

Placebo

Clascoterone (S2)

Placebo

0

Note : S1 and S2 refer to the two separate studies. Treatment success refers to both at least a 2-point improvement in IGA score (from baseline) and an IGA score of either 0 or 1. Differences compared to placebo were significant (p < 0.001).

Figure 1.

Proportion of patients achieving a treatment success.

Table 1.

Change in lesion counts between baseline and 12 weeks (data from reference 10) Lesion type

Clascoterone (S1)

Placebo

Clascoterone (S2)

Placebo

Total lesions

-39.1

-28.8

-40.0

- 23.6

Total non-inflamed

-19.4

-13.0

-19.4

-10.8

Total inflamed

-19.3

-15.5

-20.0

-12.6

www.bdng.org.uk

“success” was defined as an IGA score of 0 or 1 (if the baseline IGA was 3) or a grade 0 (where the baseline IGA was 2).9 After eight weeks there were no statistically significant differences in the proportion of subjects achieving a treatment success with values of 22% vs 12% vs 7%, for clascoterone, 0.05% tretinoin and placebo respectively.

The longer-term safety of clascoterone cream was assessed in a nine-month extension study which enrolled patients who had participated in the two phase 3 trials Phase 3 trials To date there have only been two identical, randomised, double-blind, placebo controlled phase 3 trials, and these were published in a single paper.

As with the first trial, treatment success was defined in terms of IGA scores. For instance, success was defined by IGA scores of 0 (clear) or 1 (almost clear) and a 2-grade or greater reduction in IGA score. A total of 1,440 patients with a median age of 18 years (62.6% female) were randomised to either 1% clascoterone cream, applied twice daily for 12 weeks, or placebo cream.

At entry to the study, the majority of patients (82%) had an IGA score of 3.

The proportion of participants in each group achieving a treatment success from the studies, annotated as S1 and S2, are shown in Figure 1. Both studies enrolled patients of predominately (over 80%) white ethnicity and Fitzpatrick skin types II or III.10 There were also significant reductions in the total number of lesions, as well as both non-inflamed and inflamed lesions, as shown in Table 1.

Safety In the two trials,10 clascoterone was well tolerated with a similar proportion of patients in both groups (approximately 11%) experiencing at least one treatment-emergent adverse

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Pharmacological OPINION effect (TEAEs). The most common, which accounted for less than 2% of participants, was nasopharyngitis, although in the S1 study, 3.7% of participants using the placebo cream reported this adverse effect. In total, 17 participants withdrew from both studies because of TEAEs, including application site hypersensitivity, facial acute contact dermatitis; five using clascoterone and assigned to placebo, although all TEAEs were deemed to be mild in severity.

Clascoterone (Winlevi) was approved for use by the FDA in August 2020 although it has yet to be approved in Europe or the UK

while approval will no doubt occur in the near future, a more relevant question is where the drug might fit in the acne treatment ladder. In the absence of trials with relevant comparators this becomes a difficult question to answer. For instance, might clascoterone reduce the current dependence on oral antibiotic therapy for acne? Or how well does it compare to other hormonal therapies such as spironolactone, which antagonise the action of androgens and for which there is now good evidence for its efficacy in acne?12 With an increased emphasis in treatment guidelines for the use of combination therapy that can simultaneously target more than one pathophysiological factor,13 what are the most appropriate combinations for clascoterone? Moreover, could clascoterone represent a suitable “step-down” maintenance treatment once clearance has been achieved with oral antibiotic therapy?

The longer-term safety of clascoterone cream was assessed in a nine-month extension study which enrolled patients who had participated in the two phase 3 trials.11 The study included 609 participants with 317 using clascoterone and 292 placebo, although only 347 completed the trial. Overall, 191 participants (18.1%) experienced TEAEs, of which the most common was nasopharyngitis (n = 20) and only nine participants withdrew from the study because of a TEAE, however, site application reactions including erythema, scaling/dryness and pruritus were very common.

References

Place in therapy

4. Ju Q, Tao T, Hu T, Karadag AS, Al-Khuzaei S, Chen W. Sex hormones and acne. Clin Dermatol 2017. 35(2):130-7

Clascoterone (Winlevi) was approved for use by the FDA in August 2020, although it has yet to be approved in Europe or the UK. Nevertheless,

While answers to these questions will certainly come to light in the future, at the present time, clascoterone represents a novel, topical treatment modality that will help clinicians achieve clear skin for their acne patients. DN

1. Dawson AL, Dellavalle RP. Acne vulgaris. BMJ 2013. 346:f2634 2. Collier CN HJ, Cafardi JA et al. The prevalence of acne in adults 20 years and older. J Am Acad Dermatol 2008. 58(1):56-9 3. Thiboutot D. Acne: hormonal concepts and therapy. Clin Dermatol 2004. 22(5):419-28

5. Rosette C AF, Mazzetti A et al. Cortexolone 17-alpha-proprionate (clascoterone) is a novel androgen receptor antagonist that inhibits

production of lipids and inflammatory cytokines from sebocytes in vitro. J Drugs Dermatol 2019.

15(5):412-8 6. Ferraboschi P, Legnani L, Celasco G, Moro L, Ragonesi L, Colombo D. A full conformational characterization of antiandrogen cortexolone17α-propionate and related compounds through theoretical calculations and nuclear magnetic resonance spectroscopy. Med Chem Commun 2014.

5(7):904-14 7. Mazzetti AML, Gerloni M et al.

Pharmacokinetic profile, safety and tolerability of clascoterone (cortexolone 17-alpha propionate, CB-03-01) topical cream, 1% in subjects with acne vargaris; an open-label phase 2a study. J Drugs Dermatol 2019. 18(6):563.

8. Medicinewise N. Investigator’s global assessment (IGA) of acne severity. 2011 [May 2021]. Available from: https://www.nps.org.au/ radar/articles/investigators-global-assessment-igaof-acne-severity-additional-content-adapalenewith-benzoyl-peroxide-epiduo-for-severe-acnevulgaris [last accessed June 2021] 9. Trifu V, Tiplica GS, Naumescu E, Zalupca L, Moro L, Celasco G. Cortexolone 17alphapropionate 1% cream, a new potent antiandrogen for topical treatment of acne vulgaris. A pilot randomized, double-blind comparative study vs. placebo and tretinoin 0.05% cream. Br J Dermatol 2011. 165(1):177-83 10. Hebert A, Thiboutot D, Stein Gold L, Cartwright M, Gerloni M, Fragasso E, et al.

Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol 2020. 156(6):621-30 11. Eichenfield L, Hebert A, Gold LS, Cartwright M, Fragasso E, Moro L, et al. Open-label, longterm extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris. J Am Acad Dermatol 2020. 83(2):477-85 12. Barbieri JS, Spaccarelli N, Margolis DJ, James WD. Approaches to limit systemic antibiotic use in acne: Systemic alternatives, emerging topical therapies, dietary modification, and laser and light-based treatments. J Am Acad Dermatol 2019.

80(2):538-49 13. Nast A, Dreno B, Bettoli V, Bukvic Mokos Z, Degitz K, Dressler C, et al. European evidencebased (S3) guideline for the treatment of acne - update 2016 - short version. J Eur Acad Dermatol Venereol 2016. 30(8):1261-8.

BDNG Annual Conference agenda on pages 60-61 38

Dermatological Nursing, 2021, Vol 20, No 2

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Professional DEVELOPMENT

Developing Patient Initiated Follow Up (PIFU) for people with skin conditions:

An opportunity to ensure timely personalised access to follow-up care Julia K Schofield, Jenny Wood

The NHS Long Term Plan is a commitment to redesign services by putting the patient firmly in the centre of their care. This article – the first in a short series – focuses on the development of a Patient Initiated Follow Up (PIFU) for people with skin conditions, which it is hoped will formalise the process of re-accessing care services.

Schofield JK, Wood J. Developing Patient Initiated Follow Up (PIFU) for people with skin conditions: An opportunity to ensure timely personalised access to follow-up care Dermatological Nursing 2021. 20(2):40-42

  

Introduction The ambition of the NHS Long Term Plan1 is to redesign services with highquality, personalised joined-up care, in the optimal care setting. The National Outpatients Transformation Programme (NOTP) was established by NHS

Julia K Schofield MBE is Associate Professor in Learning and Teaching University of Hertfordshire, Consultant Dermatologist United Lincolnshire Hospitals NHS Trust and Joint Dermatology Clinical Lead National Outpatient Transformation Programme (NOTP), NHS England & Improvement.

Jenny Wood is a Personalised Follow-Up Lead, National Outpatient Transformation Programme (NOTP), NHS England & Improvement.

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England and NHS Improvement in 2019 to work on transforming services to deliver these changes. The Dermatology NOTP specialty programme started work in mid-2020 and includes several workstreams,2 one of which is the development of patient initiated followup (PIFU).6 In this article we describe the generic principles that underpin PIFU as well as how we can improve the informal PIFU services that many dermatology specialist services already provide to ensure timely re-access to care for people with skin conditions.

The need for personalised care Dermatology health care professionals are familiar with the challenge of delivering services tailored to patient needs while managing clinical demand and remaining responsive. COVID-19 has only increased this challenge.

Dermatology services have long been leading the way in offering our patients access to care through nurse-led helplines and open appointments, but there is still a way to go to offer truly personalised care to patients.

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PIFU: open appointments, upgraded PIFU is a tool to help us achieve this.

It allows patients under the care of a specialist to initiate outpatient appointments when they need them, based on their individual symptoms or circumstances. PIFU lets patients who are well carry on with their lives without the stress and inconvenience of attending hospital appointments that they don’t need. It also gives confidence to patients who are experiencing symptoms or flare ups that their concerns are important and that they will be listened to.

This is not a new concept. PIFU has been around a long time and goes by different names. At first look, it sounds like the open appointment model that has been used in dermatology for several years. While similar in some sense, it is superior in that it offers patients and clinicians a more streamlined service. Improved safety nets mean that it can be used with a wider range of patients so that more people can benefit. Better defined www.bdng.org.uk

Professional DEVELOPMENT processes mean that patients can expect clearer communication and a more responsive service if they do need an appointment, while also releasing more capacity to see people who need it most. Logging and tracking patients help services forecast demand and plan clinics and staffing accordingly. Yes, it is familiar, but this is an evolved and improved version of what most of us have seen before.

For the future, not just the pandemic Formalised PIFU services have been growing in popularity over the last few years, with more and more specialities adopting it. When you see it working well, it is hard to deny that it is the right thing to do for patients, and the kind of care that we would hope to provide as part of a high-quality service. The pressure COVID-19 has put on services and waiting lists has made transforming our services more urgent, but PIFU is something we need to do to futureproof our services anyway.

Patients tell us that they prefer taking control of their own health, and want to feel trusted and in control. Patients with long-term conditions say they like not being reminded that they have a health condition by their regular timetable of appointments. PIFU is not going to be right for every patient, but the capacity it releases through avoiding unnecessary appointments benefits everyone.

There is now a national drive to implement PIFU. It has been included as part of the criteria to access funding for elective care recovery this year (Elective Recovery Fund). NHS England and NHS Improvement has published guidance on PIFU in dermatology as part of its Outpatients Transformation Programme, and we are seeing more and more hospitals rolling it out across the country.

BOX 1.

Patient thoughts on appointments “Having to go to an appointment that is not needed that can take …2 hours to 3-4 hours…

Especially if you don’t need it, seems a bit futile.”

“I understood…that he [my doctor] wouldn’t think, ‘oh, she is just having a bit of a whinge’ - she is contacting me because she needs me, because there is something not working.”

their condition. How it’s working is reviewed regularly so that it can be continuously improved and adapted at both a service and patient level.

Guidance for developing PIFU services for people with skin conditions The dermatology NOTP dermatology speciality programme has developed guidance for developing PIFU services for people with skin conditions and this section of the article describes the process used to develop the guidance and summarises some of the key messages in the document.

We hope that this information will help you to implement or strengthen PIFU arrangements for your patients in your organisation.

How was the guidance developed?

The NOTP personalised care team have a lot of generic resources which we were able to access, including a Standard Operating Policy (SOP) that describes how a PIFU service should be set up.

We were able to use these generic resources as a starting point and ask stakeholders on our NOTP dermatology Advisory Group for their views about how PIFU might work

for people with skin conditions. Our patient representatives proved key to these discussions and provided us with invaluable information about the potential benefits of this personalised approach to care. The overwhelming message from the patients and patient organisations was that this could really make a difference to the care of people with long-term skin conditions who feel that they have been left behind in terms of access to care because of the increasing emphasis on the diagnosis and management of skin cancer related to national targets. Our specialist and primary care colleagues provided their views on how the PIFU process might work, and we have been able to agree guidance that has the support of all stakeholders, and in particular our patients, who are excited about the opportunity to improve the patient experience.

Who Is PIFU likely to be suitable for and who is it not likely to be suitable for?

PIFU is ideally suited to people with long-term conditions such as psoriasis and eczema who are comfortable with managing their skin condition effectively and acting on changes in their symptoms to initiate a review appointment. The unpredictable nature of these conditions

Designed by services, around patient needs How PIFU works will depend on each individual service, local context, and IT. In general, it is based on principles of careful selection of patients, conversations with them to understand their individual needs, personal circumstances and confidence managing www.bdng.org.uk

Figure 1.

How a PIFU will work.

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Professional DEVELOPMENT

What about PIFU and people with skin cancer?

Currently, people with a diagnosis of skin cancer will have their needs met by the standards set by national cancer guidance involving access to key worker support as necessary. Some organisations may choose to use PIFU for their people with skin cancer as part of Personalised Stratified Follow-Up (PSFU).4 This is an approach that has been developed for people with breast cancer and gynaecological malignancies. 5 It is likely that PSFU will be extended to people with skin cancer in due course.

What steps need to be taken to set up your dermatology PIFU service?

The key to setting up the PIFU service is that it should be developed by the dermatology specialist team to meet the specific needs of our patients so, wherever possible, we should involve patients in the discussions about how the service can work best. Although some aspects of the service might be managed centrally, there is no place for a completely centralised PIFU service which has the potential to depersonalise rather than personalise care.

42

up) and use the information to develop and evolve the service.

Summary

Agree clear criteria for the relevant groups of patients with skin conditions that will be suitable for the service and the likely timeline for the PIFU; this could be several years for people with psoriasis Decide how the patients should access the service: a mix of answerphone and a contact email address can work well and allow some preliminary screening of messages by administrative staff with triage to relevant clinicians as appropriate Think about arrangements for either call-back or email response to the patient to understand the symptoms that the patient is having and an agreed timeframe which would usually be expected to be two working days Develop written information for the patient and information for the GP about how the service works Think about continuity of care and the importance of the request for a PIFU being passed to the healthcare professional that agreed the PIFU with the patient, to make a decision about appropriate next steps Arrangements for PIFU will vary depending on the size and special interests of the department; there may need to be different PIFU arrangements for patients with different conditions Work out with your appointments team an agreed process for booking the necessary clinical interaction in response to the PIFU in a timely fashion appropriate to the patient; this could be a telephone, video or face-to-face consultation Decide upon an administrative process for recording patients on a PIFU with a clear plan for what will happen at the end of the PIFU timescale Make sure that you are collecting information about patient experience and satisfaction, the outcomes of any PIFU interactions (referral for phototherapy, consultant review, back on PIFU, regular follow-

Dermatological Nursing, 2021, Vol 20, No 2

The COVID-19 pandemic has created serious challenges for specialist teams to provide personalised care for patients with long-term conditions. There is a risk that patients have had appointments cancelled and not reinstated and have been ‘lost to follow-up’. Consolidating and formalising our helpline services by implementing PIFU will help ensure that, in future, all patients will be able to reaccess care from a specialist in a timely fashion. Clinicians will need to accept that this change may mean that the complexity of their caseload increases as the more straightforward patients are no longer under regular review. We hope that we have persuaded you to take forward this approach and move towards offering the personalised care that our patients deserve. DN

RELIEF FROM STINGING AND DRYNESS ASSOCIATED WITH ACNE MEDICATION

There are some obvious situations where PIFU services are not appropriate, for example if people and/or their carers have impaired cognitive function, or for people who lack confidence in selfmanagement and re-accessing services.

With regard to specific patient groups, PIFU would not be expected to replace the regular monitoring appointments required by people on long-term systemic treatments such as biological therapies, but could be used in addition to regular reviews.

The following list summarises the key steps for you to think about when setting up your service:

DERMOPURIFYER

makes them well-suited to this approach to ensure prompt access to specialist care when necessary, in order to ensure swift control of their condition. Other patients who can benefit from this approach are people who are seen by a specialist and started on treatment where a flexible approach to a review appointment is necessary. For people with psoriasis whose condition flares, the use of PIFU for a rapid assessment provides the opportunity for people to access treatment such as phototherapy in a timely fashion.

To find out more or get involved please contact us – NHS England and NHS Improvement’s National Outpatient Transformation Programme at nhsi.outpatienttransformation@nhs.net.

References

1. NHS. NHS Long Term Plan. Available at: https://www.longtermplan.nhs.uk/ [last accessed May 2021] 2. Schofield JK, Le Roux E. The National Outpatient Transformation Programme.

Dermatological Nursing 2021. 20(1):6

3. NHS. Patient Initiated Follow Up: Giving patients greater control over their hospital followup care. Available at: https://www.england.nhs.uk/ outpatient-transformation-programme/patientinitiated-follow-up-giving-patients-greater-controlover-their-hospital-follow-up-care/ [last accessed May 2021] 4. NHS. Implementing personalised stratified follow-up pathways 2020. Available at: https:// www.england.nhs.uk/publication/implementingpersonalised-stratified-follow-up-pathways/ [last accessed May 2021] 5. Newton C, Nordin A, Rolland P, Ind T, Larsen-Disney P, Martin-Hirsch P et al. British Gynaecological Cancer Society recommendations and guidance on patient-initiated follow-up (PIFU).

International Journal of Gynecological Cancer 2020.

Available at: https://www.bgcs.org.uk/wp-content/ uploads/2020/04/IJGC-British-GynaecologicalCancer-Society-recommendations-and-guidance-onpatient-initiated-follow-up-PIFU.pdf www.bdng.org.uk

87% 85%

84%

Stinging/Burning (n=244)

Tightness (n=298)

Roughness (n=299)

79%

Dryness (n=367)

73%

Combine with Eucerin® Oil Control Dry Touch: Sun Protection for blemish-prone skin

Combine with Eucerin® Oil Control Dry Touch: Sun Protection for blemish-prone skin

87%

Worsened

• Symsitive® soothes irritations directly at the source by reducing responsiveness of nerve fibres

• Symsitive® soothes irritations directly at the source by reducing responsiveness of nerve fibres

Unchanged

• Anti-inflammatory Licochalcone A helps to alleviate skin redness

• Anti-inflammatory Licochalcone A helps to alleviate skin redness

Improved

• Ceramides enhance skin’s protective barrier and reduce moisture loss

• Ceramides enhance skin’s protective barrier and reduce moisture loss

DERMATOLOGISTS’ ASSESSMENT OF HOW PRONOUNCED SYMPTOMS ARE AFTER 4 WEEKS OF USE 1

• Intensively moisturising formula

• Intensively moisturising formula

Improved

Over 90% of patients confirm: soothes skin under medical acne treatment and reduces dryness1

Erythema (n=347)

Symsitive® registered trademark of Symrise, Germany (1) Study design: n = 415 patients (mean age 22.5 years, 67% women, 32% men), self-assessment and expert assessment from 7 countries (Croatia, Czech Republic, Estonia, Hungary, Latvia, Serbia, Slovakia). Patients under medical acne treatment applied Eucerin® DERMOPURIFYER ADJUNCTIVE SOOTHING CREAM at least once daily over a period of 4 weeks.

Patients used for sun protection Eucerin® SUN OIL CONTROL DRY TOUCH when needed (most once per day). No other face skin care products were used during the study period.

LIFE - CHANGING POWER OF DERMATOLOGICAL SKINCARE

Roughness (n=299) Tightness (n=298) Stinging/Burning (n=244)

Unchanged

84%

Eucerin® DermoPurifyer Adjunctive Soothing Cream

Symsitive® registered trademark of Symrise, Germany (1) Study design: n = 415 patients (mean age 22.5 years, 67% women, 32% men), self-assessment and expert assessment from 7 countries (Croatia, Czech Republic, Estonia, Hungary, Latvia, Serbia, Slovakia). Patients under medical acne treatment applied Eucerin® DERMOPURIFYER ADJUNCTIVE SOOTHING CREAM at least once daily over a period of 4 weeks.

Patients used for sun protection Eucerin® SUN OIL CONTROL DRY TOUCH when needed (most once per day). No other face skin care products were used during the study period.

Erythema (n=347) Dryness (n=367)

73% 79% 85% Worsened

DERMATOLOGISTS’ ASSESSMENT OF HOW PRONOUNCED SYMPTOMS ARE AFTER 4 WEEKS OF USE 1

73%

Erythema (n=347)

Over 90% of patients confirm: soothes skin under medical acne treatment and reduces dryness1

79%

Dryness (n=367)

Eucerin® DermoPurifyer Adjunctive Soothing Cream

85%

Worsened

84%

Roughness (n=299)

Eucerin® DermoPurifyer Adjunctive Soothing Cream

Unchanged

Tightness (n=298)

DERMATOLOGISTS’ ASSESSMENT OF HOW PRONOUNCED SYMPTOMS ARE AFTER 4 WEEKS OF USE 1

Improved

87%

Stinging/Burning (n=244)

Symsitive® registered trademark of Symrise, Germany (1) Study design: n = 415 patients (mean age 22.5 years, 67% women, 32% men), self-assessment and expert assessment from 7 countries (Croatia, Czech Republic, Estonia, Hungary, Latvia, Serbia, Slovakia). Patients under medical acne treatment applied Eucerin® DERMOPURIFYER ADJUNCTIVE SOOTHING CREAM at least once daily over a period of 4 weeks.

Patients used for sun protection Eucerin® SUN OIL CONTROL DRY TOUCH when needed (most once per day). No other face skin care products were used during the study period.

LIFE - CHANGING POWER OF DERMATOLOGICAL SKINCARE EUCERIN.CO.UK

DERMOPURIFYER

Over 90% of patients confirm: soothes skin under medical acne treatment and reduces dryness1

• Intensively moisturising formula

• Ceramides enhance skin’s protective barrier and reduce moisture loss

• Anti-inflammatory Licochalcone A helps to alleviate skin redness

• Symsitive® soothes irritations directly at the source by reducing responsiveness of nerve fibres

Combine with Eucerin® Oil Control Dry Touch: Sun Protection for blemish-prone skin

LIFE - CHANGING POWER OF DERMATOLOGICAL SKINCARE

RELIEF FROM STINGING AND DRYNESS ASSOCIATED WITH ACNE MEDICATION

Olumiant is the First Oral JAK inhibitor approved for adult patients with moderate to severe atopic dermatitis (AD)1,2 Olumiant is indicated for the treatment of moderate to severe AD in adult patients who are candidates for systemic therapy.1

References: 1. Olumiant® Summary of product characteristics.

2. Ref 49093 Eli Lilly and Company Press Release October 2020.

Olumiant®

(baricitinib) PRESCRIBING INFORMATION

Presentation Olumiant 2 mg film-coated tablet contains 2 mg of baricitinib.

Olumiant 2 mg tablet is a light pink, 9.0 x 7.5 mm oblong tablets, debossed with “Lilly” on one side and “2” on the other. Olumiant 4 mg film-coated tablet contains 4 mg of baricitinib. Olumiant 4 mg tablet is a medium pink, 8.5 mm round tablets, debossed with “Lilly” on one side and “4” on the other. Uses Rheumatoid Arthritis Olumiant is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Olumiant may be used as monotherapy or in combination with methotrexate. Atopic Dermatitis Olumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. Dosage and Administration Treatment should be initiated by physicians experienced in the diagnosis and treatment of the conditions for which Olumiant is indicated.

Posology Rheumatoid Arthritis: The recommended dose of Olumiant is 4 mg once daily. A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections. A dose of 2 mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering. Atopic Dermatitis: The recommended dose of Olumiant is 4 mg once daily. A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections. A dose of 2 mg once daily should be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering. Olumiant can be used with or without topical corticosteroids. The efficacy of Olumiant can be enhanced when given with topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for sensitive areas only, such as the face, neck, intertriginous and genital areas. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit after 8 weeks of treatment. Treatment initiation: Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) less than 0.5 x 109 cells/L, an absolute neutrophil count (ANC) less than 1 x 109 cells/L, or who have a haemoglobin value less than 8 g/dL. Treatment may be initiated once values have improved above these limits. Renal impairment: The recommended dose is 2 mg once daily in patients with creatinine clearance between 30 and 60 mL/min. Olumiant is not recommended for use in patients with creatinine clearance < 30 mL/min (see the SmPC for full information). Hepatic impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. Olumiant is not recommended for use in patients with severe hepatic impairment (see the SmPC for full information). Co-administration with OAT3 inhibitors: The recommended dose is 2 mg once daily in patients taking Organic Anion Transporter 3 (OAT3) inhibitors with a strong inhibition potential, such as probenecid (see the SmPC for full information). No clinical pharmacology study has been conducted with OAT3 inhibitors with less inhibition potential. The prodrug leflunomide rapidly converts to teriflunomide which is a weak OAT3 inhibitor and therefore may lead to an increase in baricitinib exposure. Since dedicated interaction studies have not been conducted, caution should be used when leflunomide or teriflunomide are given concomitantly with baricitinib (see the SmPC for full information on Interaction with other medicinal products and other forms of interaction). Elderly: Clinical experience in patients ≥ 75 years is very limited and in these patients a starting dose of 2 mg is appropriate. Paediatric population: The safety and efficacy of Olumiant in children and adolescents aged 0 to 18 years have not yet been established. No data are available. Method of administration Oral use: Olumiant is to be taken once daily with or without food and may be taken at any time of the day. Contra-indications Hypersensitivity to the active substance or to any of the excipients listed in the SmPC. Pregnancy: Women of childbearing potential have to use effective contraception during and for at least 1 week after treatment. If a patient becomes pregnant while taking Olumiant the parents should be informed of the potential risk to the foetus.

Warnings and Special Precautions Infections: Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo (see the SmPC for full information). In rheumatoid arthritis clinical studies, in treatment naïve patients, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy. The risks and benefits of treatment with Olumiant should be carefully considered prior to initiating therapy in patients with active, chronic or recurrent infections (see the SmPC for full information). If an infection develops, the patient should be monitored carefully and

Olumiant therapy should be temporarily interrupted if the patient is not responding to standard therapy. Olumiant treatment should not be resumed until the infection resolves. Tuberculosis: Patients should be screened for tuberculosis (TB) before starting Olumiant therapy. Olumiant should not be given to patients with active TB. Anti-TB therapy should be considered prior to initiation of Olumiant in patients with previously untreated latent TB. Haematological abnormalities: Absolute Neutrophil Count (ANC) < 1 x 109 cells/L and Absolute Lymphocyte Count (ALC) < 0.5 x 109 cells/L were reported in less than 1 % of patients in clinical trials.

Haemoglobin < 8 g/dL was reported in less than 1 % of patients in rheumatoid arthritis clinical trials. Treatment should not be initiated, or should be temporarily interrupted, in patients with an ANC < 1 x 109 cells/L, ALC < 0.5 x 109 cells/L or haemoglobin < 8 g/dL observed during routine patient management (see section 4.2 of the SmPC for further information). The risk of lymphocytosis is increased in elderly patients with rheumatoid arthritis. Rare cases of lymphoproliferative disorders have been reported. Viral reactivation: Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster, herpes simplex), were reported in clinical studies (see the SmPC for full information). In rheumatoid arthritis clinical studies, herpes zoster was reported more commonly in patients ≥ 65 years of age who had previously been treated with both biologic and conventional DMARDs. If a patient develops herpes zoster, Olumiant treatment should be temporarily interrupted until the episode resolves. Vaccination: Use with live, attenuated vaccines during, or immediately prior to, Olumiant therapy is not recommended.

Prior to initiating Olumiant, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.

Lipids: Dose dependent increases in blood lipid parameters were reported in patients treated with baricitinib compared to placebo (see the SmPC for full information). Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin therapy. Lipid parameters should be assessed approximately 12 weeks following initiation of Olumiant therapy and thereafter patients should be managed according to international clinical guidelines for hyperlipidaemia. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. Hepatic transaminase elevations: Dose dependent increases in blood alanine transaminase (ALT) and aspartate transaminase (AST) activity were reported in patients treated with baricitinib compared to placebo (see section 4.8). Increases in ALT and AST to ≥ 5 and ≥ 10 x upper limit of normal (ULN) were reported in less than 1 % of patients in clinical trials. In rheumatoid arthritis clinical studies in treatment-naïve patients, combination with methotrexate resulted in increased frequency of hepatic transaminase elevations compared with baricitinib monotherapy (see the SmPC for full information). If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, Olumiant should be temporarily interrupted until this diagnosis is excluded. Malignancy: The risk of malignancies including lymphoma is increased in patients with rheumatoid arthritis. Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma. The clinical data are insufficient to assess the potential incidence of malignancies following exposure to baricitinib. Venous Thromboembolism: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving baricitinib.

Olumiant should be used with caution in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of DVT/PE, or patients undergoing surgery and immobilisation. If clinical features of DVT/PE occur, Olumiant treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment. Laboratory monitoring: Please refer to the SmPC for laboratory measures and monitoring guidance. Immunosuppressive medicinal products: Combination with biologic DMARDs, biologic immunomodulators or other Janus kinase (JAK) inhibitors is not recommended, as a risk of additive immunosuppression cannot be excluded. In rheumatoid arthritis, data concerning use of baricitinib with potent immunosuppressive medicinal products (e.g., azathioprine, tacrolimus, ciclosporin) are limited and caution should be exercised when using such combinations (see the SmPC for full information). In atopic dermatitis, combination with ciclosporin or other potent immunosuppressants has not been studied and is not recommended (see the SmPC for full information).

Hypersensitivity: In post-marketing experience, cases of drug hypersensitivity associated with baricitinib administration have been reported. If any serious allergic or anaphylactic reaction occurs, baricitinib should be discontinued immediately.

Diverticulitis: Events of diverticulitis and gastrointestinal perforation have been reported in clinical trials and from postmarketing sources. Baricitinib should be

Olumiant® and Lilly are registered trademarks of Eli Lilly and Company.

PP-BA-GB-1059 May 2021. © 2021 Eli Lilly and Company. All rights reserved.

used with caution in patients with diverticular disease and especially in patients chronically treated with concomitant medications associated with an increased risk of diverticulitis: nonsteroidal anti-inflammatory drugs, corticosteroids, and opioids.

Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation. Interactions See the SmPC for full information on interaction with immunosuppressive medicinal products, potential for other medicinal products to affect the pharmacokinetics of baricitinib, and potential for baricitinib to affect the pharmacokinetics of other medicinal products. Fertility, Pregnancy, and Lactation Pregnancy: There are no adequate data from the use of baricitinib in pregnant women. Studies in animals have shown reproductive toxicity (see the SmPC for full information). Baricitinib was teratogenic in rats and rabbits Olumiant is contraindicated during pregnancy. Breast-feeding: It is unknown whether baricitinib/metabolites are excreted in human milk. Available pharmacodynamic/ toxicological data in animals have shown excretion of baricitinib in milk. A decision must be made whether to discontinue breast-feeding or to discontinue Olumiant therapy. Fertility: The effect of baricitinib on human fertility has not been evaluated.

Studies in animals suggest that treatment with baricitinib has the potential to decrease female fertility while on treatment, but there was no effect on male spermatogenesis. Effects on ability to drive and use machines Olumiant has no or negligible influence on the ability to drive and use machines. Undesirable Effects Summary of the safety profile: In placebo-controlled rheumatoid arthritis clinical trials, for up to 16 weeks, the most commonly reported adverse drug reactions occurring in ≥ 2 % of patients treated with Olumiant monotherapy or in combination with conventional synthetic DMARDs were increased LDL cholesterol (33.6 %), upper respiratory tract infections (14.7 %) and headache(3.8 %).

Infections reported with Olumiant treatment included herpes zoster (1.4 %). In placebo-controlled atopic dermatitis clinical trials, for up to 16 weeks, the most commonly reported ADRs occurring in ≥ 2 % of patients treated with Olumiant monotherapy or in combination with topical corticosteroids were similar to those observed in rheumatoid arthritis, except for increased LDL cholesterol (13.2 %) and herpes simplex (6.1 %). In patients treated with baricitinib in the atopic dermatitis clinical trials, the frequency of herpes zoster was very rare. Very common (≥ 1/10): Upper respiratory tract infection, Hypercholesterolaemia, Common (≥ 1/100 to < 1/10): Herpes zoster, Herpes simplex, Gastroenteritis, Urinary tract infections, Pneumonia, Thrombocytosis > 600 x 109 cells/L, Headache, Nausea, Abdominal pain, ALT increased ≥ 3 x ULN, Rash, Acne, Creatine phosphokinase increased > 5 x ULN. Uncommon (≥ 1/1,000 to < 1/100): Neutropaenia < 1 x 109 cells/L, Hypertriglyceridaemia, Diverticulitis, AST increased ≥ 3 x ULN, Swelling of the face, Urticaria, Pulmonary embolism, Deep Vein Thrombosis, Weight increased. For full details of these and other side-effects, please see the Summary of Product Characteristics, which is available at United Kingdom: http://www.medicines.org.uk/emc/, or Ireland: http://www.medicines. ie/. Legal Category POM Marketing Authorisation Numbers and Holder EU/1/16/1170/002, EU/1/16/1170/010, Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. Cost (UK only) £805.56 per pack of 28 x 2 mg film-coated tablets, £805.56 per pack of 28 x 4 mg film-coated tablets, An Irish price is available on request; please see section below for contact information. Date of Preparation or Last Review: November 2020 Further information is available from Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL. Telephone: UK: + 44-(0) 1256 315000, Ireland: + 353-(0) 1 661 4377, E-mail: ukmedinfo@lilly. com, Website: www.lilly.co.uk; www.lilly.ie.

Adverse events and product complaints should be reported.

Reporting forms and information can be found at UK: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store, or Ireland: www.hpra.ie.

Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000, or Lilly Ireland on 01 664 0446.

Research SKILLS

What are quantitative and qualitative research methods?

A brief introduction Joanne Chalmers, Fiona Cowdell This paper is the second in a series devoted to dermatological nursing research. In the first paper we reported the findings of a national survey conducted to scope dermatology nurses’ current roles in, understanding of, and development needs in relation to research. Our next article addresses critical appraisal skills. In this short article, we first define evidence-based practice and the need for nursing research to contribute to this agenda. We then offer a brief overview of quantitative, qualitative and mixed method approaches to research. Finally, we suggest some key reading.

Chalmers J, Cowdell F. What are quantitative and qualitative research methods? A brief introduction. Dermatological Nursing 2021. 20(2):45-48 The foundation of evidence-based practice (EBP) can be traced back to Florence Nightingale in the 1800s.1 EBP is defined as “a problem-solving approach to clinical decision making that incorporates a search for the best and latest evidence, clinical expertise and assessment, and patient preference values within a context of caring.”2 EBP is grounded in the principle that patient care should be informed by sound evidence and has much in common with evidence-based medicine (EBM).

The founding definition of evidencebased medicine is “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients”.3 EBP is not about research dictating what you should do in clinical practice.

It is about taking the best research evidence available and using it in the context of the individual patient, in combination with your clinical experience and the patient’s views. Using Jo Chalmers is a Senior Research Fellow, Centre of Evidence Based Dermatology, University of Nottingham. Fiona Cowdell is Professor of Nursing and Health Research, Faculty of Health, Education and Life Sciences, Birmingham City University www.bdng.org.uk

EBP means the patient will be getting the best and most appropriate care available. However, it is important that EBP is based on the best quality evidence available, and so being able to identify the difference between good and poorquality research is crucial. An article later in this series will give you some guidance on how to do this by understanding how to critically appraise research.

EBP is not about research dictating what you should do in clinical practice Underpinning all EBP is research.4 All good research starts with a relevant and timely question. The question might come from a long-standing frustration that you do not have the information you need to advise a patient. Or perhaps a patient asks you the basis on which you are giving advice and you are aware that it is not based on any evidence.

Once the question is formed, there are two fundamentally different approaches to answering it: quantitative and qualitative research, or a careful combination of both. Quantitative

research is all about numbers and includes, for example, trials and cohort studies. Qualitative research is descriptive and uses words and language in situations such as discussion groups and interviews to explore participants’ perspectives. All good research has a value, what is important is that the right method is used to answer the question. If you want to know how effective drug A is compared to drug B in a particular skin condition, then you need a quantitative study that will give you a numerical answer to how well a sample population responds to each treatment. A qualitative study, on the other hand, will give a deep understanding of people’s experiences and beliefs about, for example, their condition or healthcare. A good way to think about the two broad approaches is that quantitative research provides the “what” and qualitative research gives insight into the “why” and/or the “how”.

The two different approaches can be used independently, or they can be used together in mixed methods studies to offer a holistic answer to the question. 5 For example, when conducting a randomised controlled trial (quantitative) it can be valuable to to conduct interviews with selected participants to gain a nuanced understanding about

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45

Research SKILLS specific issues, such as adherence or perceived effectiveness.

In the rest of this article, we will look at what different types of quantitative and qualitative research methods are commonly used in clinical research, and some of the advantages and disadvantages of each.

What is quantitative research?

There are several different study designs that all provide numerical data. These include studies such as clinical trials, cohort studies and systematic reviews.

Their objective nature means they are generally well accepted in the clinical and scientific world. However, it is important to remember that different designs provide different levels of certainty of the evidence, known as the evidence pyramid. The evidence pyramid illustrates both quality and volume of evidence available at each level. For example, there are fewer meta-analyses than randomised controlled trials, and since the former synthesises the latter, this evidence may be more useful. The evidence pyramid is problematic in that

the focus is on quantitative research methods and it takes no account of evidence garnered from sources other than research.

Randomised controlled trials The randomised controlled trial (RCT) is considered to be the gold standard research design to answer a clinical question.6 A sample of patients with the disease of interest are randomly allocated to either the intervention or the control group, so they are always interventional studies. Randomly allocating patients to their group removes much of the potential bias and therefore gives a more confident answer. The outcomes in the two groups are then compared to determine which treatment is better. Outcomes can be clinician or patient reported outcomes, but it is important that the patient perspective is considered.

Systematic reviews Ideally there will be multiple RCTs looking at a particular question as one trial alone can provide an erroneous finding, and these trials can be brought

Figure 1.

The Evidence Pyramid 46

Dermatological Nursing, 2021, Vol 20, No 2

together in a systematic review. Metaanalysis can then be used if the trials are similar enough in their design. This statistical technique allows the results of several trials to be combined to provide an overall answer, or “effect estimate”. This is the highest level of evidence on the evidence pyramid for EBP, but a systematic review is only as good as the studies that go into it. A commonly used phrase in the reviewing world is “rubbish in = rubbish out”.

Good quality clinical guidelines are usually based on systematic reviews that integrate evidence and give a clear picture of quality of the evidence base and knowledge gaps. The Cochrane Collaboration reviews are amongst the best sources of evidence to inform clinical guidelines that are available.

Cohort studies Clinical trials are notoriously expensive to deliver and tend to be relatively short in duration, with participants numbering often in the hundreds rather than tens of thousands. Consequently, they are not designed to pick up rare side effects, or side effects that take a long time to develop. Therefore, a long-term prospective cohort study of 10,000+ patients is more likely to be a suitable study design for this type of question. A prospective cohort study is one in which patients are recruited into the cohort and then data is collected on the outcomes of interest from that point onwards. A retrospective cohort is usually considered lower quality because it can be subject to significant bias.

They rely on the recall of patients to remember events and what treatment they had received, or if using preexisting records, the records may not be accurate or contain all the relevant information.

Case control study A case control study is lower on the evidence pyramid because it simply takes people that have the disease and compares them to people that do not, in order to decide whether something is a risk factor or not. There is huge potential for bias in studies of this design, so, whilst they can be good for hypothesis generating, they are less useful for reaching definitive conclusions. www.bdng.org.uk

Research SKILLS Even lower down are case series and case reports in which initial observations on a group of patients, or even just one patient, are reported. Again, these are important in terms of generating research questions but are not good quality evidence for evidence-based decision making.

What is qualitative research?

There are many types of qualitative research, for example, grounded theory, ethnography, case study and phenomenology. Rather than being concerned about specific approaches, it is more useful to understand the underlying principles and core elements of the qualitative approach. The aim in qualitative research is to provide indepth insights and understanding of realworld issues. In contrast to quantitative research, it does not test treatments, manipulate, or quantify variables.7 A fundamental assumption in qualitative research is that reality is a phenomenon constructed by individuals.8 The subjective view of reality explored in this type of research is important and has real consequences for understanding and improving patient care.

Core elements of qualitative research are summarised in Box 1 and some are discussed in more detail below.

Interviews and focus groups Interviews are frequently used to collect qualitative data. These are individual conversations which may be conducted face-to-face or via video or telephone, and generally last between 30-90 minutes. The structure of an interview will vary according to the research question and method. There is a continuum of the degree of structure employed but all use open-ended questions and give participants the opportunity to speak freely. One of the benefits of an interview study is the indepth nature of the data collected. It is also important that the person carrying out the interviews understands how to do them to avoid leading questions or overly influencing the participant.9 Focus groups bring people together for a group discussion, rather than talking individually to participants. Each www.bdng.org.uk

group is usually around eight to 10 participants, lasts one to two hours and will be moderated by a researcher.

Typically focus groups are held in a room face-to-face but the use of online platforms to host the groups is increasing. Focus groups require significant planning and organisation and can be expensive due to travel costs, venue hire and refreshments. There is also a danger that the more confident participants can dominate discussions, but a good facilitator can mitigate against this. A key benefit of focus groups is the production of significant insights from group dynamics and discussions.10 Both interviews and focus groups are, with permission from participant(s), audio or video recorded. Recordings are transcribed word-for-word and systematically analysed by the research team to organise the data and identify themes using an established technique congruent with the research approach being used. Commonly used techniques include thematic, content11 and framework12 analysis.

More recently, researchers have capitalised on the rich source of data on social media and methods have been developed for analysing this pre-existing data. The benefit here is that the data are readily available making it efficient

and relatively low-cost to conduct, but as it was not generated for a specific purpose, there may be limitations in the conclusions that can be drawn.13

The aim in qualitative research is to provide in-depth insights and understanding of real-world issues Observation Observation is a core method of data collection in ethnographic research as it offers the opportunity to view participants’ behaviour in the context of the ‘real world’.14 Data is generally collected in the form of written field notes recorded contemporaneously or soon after periods of observation.

Observation studies are good for understanding a culture because it is based on what the researcher observes rather than people’s opinion or perspective on that culture. A skilled researcher can become “part of the furniture” that participants no longer notice, with practice continuing as usual.

The major advantage of observation is that it reveals day-to-day practice and avoids the potential issue of participants being told what they think you may want

BOX 1.

Core elements of qualitative research The aim is to uncover a deep understanding of individual’s experiences, perceptions, behaviour and processes and the meanings attached to them.

Participants are recruited because of their experience of, or knowledge about, the phenomenon.

The researcher is the instrument of data collection and reflexivity is essential.

The researcher must be transparent about their own preconceived ideas and influence on the study.

Data are generally collected though one or a combination of: interviews, focus groups, observation, or document/artefact review.

Interview/focus group questions are generally open-ended and encourage depth and detail of response.

Data collection and analysis are iterative processes that happen in parallel as the study progresses.

Data are analysed inductively using specific, rigorous techniques and presented in a way that best addresses the research question.

Research method must be transparent, rigorous and well reported.

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Research SKILLS to hear – something that can occur in interviews and focus groups. Depending on the nature of the question, observations can range from weeks or months or, in exceptional circumstances, years. Key informants identified during observation are often invited to participate in interviews, which can deepen the researchers understanding of the culture.

Rigour As with all research, qualitative studies must be rigorous. The researcher must offer a transparent account of the whole research process including: defining the research question, justifying the chosen method, reporting sampling strategy and methods of data collection, explaining the process of data analysis, demonstrating trustworthiness and offering a reflexive account.15

Mixed methods In mixed methods studies researchers collect and analyse both quantitative and qualitative data in the same study.

This approach draws on the strengths of both qualitative and quantitative methods and enables researchers to investigate different perspectives and holistically answer complex research questions. Mixed methods research requires deliberate combination of methods in data collection, data analysis, and interpretation of the evidence and most importantly, to provide the added value, there must be integration or “triangulation” of data to produce a rounded analysis.16

Conclusion In this article, we have explored the meaning of evidence-based practice. We have examined the evidence pyramid and considered its limitations when applied to dermatology nursing. As with other healthcare practitioners, we need to base our practice on a skillful melding of available research evidence applied in the context of the individual patient and their views, in combination with your clinical experience and expertise.

We have briefly introduced quantitative, qualitative and mixed-methods research and highlighted how each may contribute to generating a robust evidence base for practice. DN 48

References 1. Mackey A, Bassendowski S. The history of evidence-based practice in nursing education and practice. Journal of Professional Nursing 2017.

33(1):51-5 2. International Council of Nurses. Closing the gap: From evidence to action. Available at http:// www.icn.ch/publications/2012-closing-the-gapfrom-evidence-to-action/ 3. Sackett DL, Rosenberg WM, Gray JM, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ 1996. 312: 71-72 4. Saunders H, Gallagher‐Ford L, Kvist T, Vehviläinen‐Julkunen K. Practicing healthcare professionals’ evidence‐based practice competencies: An overview of systematic reviews.

Worldviews on Evidence‐Based Nursing 2019.

16(3):176-85 5. Bressan V, Bagnasco A, Aleo G, Timmins F, Barisone M, Bianchi M et al. Mixed‐methods research in nursing–a critical review. Journal of Clinical Nursing 2017. 26(19-20):2878-90 6. Tam W, Lo K, Woo B. Reporting sample size calculations for randomized controlled trials published in nursing journals: A cross-sectional study. International Journal of Nursing Studies 2020.

102:103450 7. Miller WR. Qualitative research findings as evidence: utility in nursing practice. Clinical Nurse Specialist 2010. 24(4):191 8. Creswell J. Research Design: Qualitative & Quantitative Approaches. Thousand Oaks, CA: Sage Publications; 1994 9. Peters K, Halcomb E. Interviews in qualitative research. Nurse Researcher 2015. 22(4):6 10. Jayasekara RS. Focus groups in nursing research: methodological perspectives. Nursing Outlook 2012. 60(6):411-6 11. Vaismoradi M, Turunen H, Bondas T. Content analysis and thematic analysis: Implications for conducting a qualitative descriptive study. Nursing & Health Sciences 2013. 15(3):398-405 12. Ward DJ, Furber C, Tierney S, Swallow V. Using Framework Analysis in nursing research: a worked example. Journal of Advanced Nursing 2013. 69(11):2423-31 13. Golder S, Ahmed S, Norman G, Booth A. Attitudes toward the ethics of research using social media: a systematic review. Journal of Medical Internet Research 2017. 19(6):e195 14. Fetterman DM. Ethnography Step-By-Step.

Third edition. Sage Publications, Thousand Oaks CA. 2010 15. Kalu FA, Bwalya JC. What makes qualitative research good research? An exploratory analysis of critical elements. International Journal of Social Science Research 2017. 5(2):43-56 16. Shorten, A and Smith, J. Mixed methods research: expanding the evidence base. Evidencebased Nursing 2017. 20(3):74-75.

Dermatological Nursing, 2021, Vol 20, No 2

Key points Evidence-based practice is essential to enable you to provide the best possible patient care Two broad types of clinical research that can be used for EBP, qualitative and quantitative Quantitative methods provide the “what” and are numerical studies like clinical trials, whereas qualitative studies give insight into the “how” and “why” and involve methods such as interviews and focus groups.

Webinar Please join us at 7.00pm on Wednesday 14th July for a onehour webinar to further explore how different research methods are used to answer different types of research question. To help make the session relevant to dermatology nursing (and hopefully more fun!) it would be fantastic if some of you could pre-submit research ideas/ questions for discussion during the session, so we have real-world examples from the dermatology nursing community to think about and explore. Please send these (no more than a couple of sentences) to ukdctn@nottingham.ac.uk no later than Mon 12th July. This online session will be facilitated by UK DCTN Network Manager Carron Layfield with research expertise provided by Prof Fiona Cowdell and Prof Kim Thomas and is a relaxed and informal environment.

To register please contact https://bdng.org.uk/research-2 Further reading Harvey M, Land L (2016) Research Methods for Nurses and Midwives: Theory and Practice: Theory and Practice. London, Sage.

Holloway I, Galvin K (2016) Qualitative Research in Nursing and Healthcare. Oxford. Wiley Blackwell.

Saks M, Allsop J (2019) Researching Health: Qualitative, Quantitative and Mixed Methods.

London, Sage. www.bdng.org.uk

Created and developed by LEO Pharma.

This is a promotional advertisement for UK/IE healthcare professionals only.

Learn more at DERMAWorld

Active f lare management and maintenance treatment of adult plaque psoriasis1 Enstilar® is indicated for the topical treatment of psoriasis vulgaris in adults.1

treatment during the active flare…1-4

Prescribing Information for Enstilar® (calcipotriol/betamethasone) 50 micrograms/g + 0.5 mg/g cutaneous foam Please refer to the full Summary of Product Characteristics (SmPC) (www.medicines.org.uk/emc or www.medicines.ie) before prescribing.

Indication: Topical treatment of psoriasis vulgaris in adults. Active ingredients: 50 µg/g calcipotriol (as monohydrate) and 0.5 mg/g betamethasone (as dipropionate). Dosage and administration: Flare treatment: Apply by spraying onto affected area once daily. Recommended treatment period is 4 weeks. If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular supervision. Longterm maintenance treatment: Patients who have responded at 4 weeks’ treatment using Enstilar once daily are suitable for long-term maintenance treatment. Enstilar should be applied twice weekly on two non-consecutive days to areas previously affected by psoriasis vulgaris. Between applications there should be 2-3 days without Enstilar treatment. If signs of a relapse occur, flare treatment, as described above, should be re-initiated. Maximum dose: The daily maximum dose of Enstilar should not exceed 15 g, i.e. one 60 g can should last for at least 4 days of treatment. 15 g corresponds to the amount administered from the can if the actuator is fully depressed for approximately one minute. A two-second application delivers approximately 0.5 g. As a guide, 0.5 g of foam should cover an area of skin roughly corresponding to the surface area of an adult hand. If using other calcipotriol-containing medical products in addition to Enstilar, the total dose of all calcipotriol-containing products should not exceed 15 g per day. Total body surface area treated should not exceed 30%. Safety and efficacy in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. Safety and efficacy in children below 18 years have not been established. Shake the can for a few seconds before use. Apply by spraying, holding the can at least 3 cm from the skin, in any orientation except horizontally. Spray directly onto each affected skin area and rub in gently. If used on the scalp, spray into the palm of the hand then apply to affected scalp areas with the fingertips. See hair washing instructions in the package leaflet. Wash hands after use (unless Enstilar is used to treat the hands) to avoid accidentally spreading to other parts of the body as well as unintended drug absorption on the hands. Avoid application under occlusive dressings since systemic absorption of corticosteroids increases. It is recommended not to take a shower or bath immediately after application. Let the foam remain on the scalp and/or skin during the night or during the day. Contraindications: Hypersensitivity to the active substances or any of the excipients. Erythrodermic and pustular psoriasis. Patients with known disorders of calcium metabolism. Viral (e.g. herpes or varicella) skin lesions, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris,

maintenance treatment for long-term control1,5

acne rosacea, rosacea, ulcers and wounds. Precautions and warnings: Adverse reactions found in connection with systemic corticosteroid treatment, e.g. adrenocortical suppression or impaired glycaemic control of diabetes mellitus, may occur also during topical corticosteroid treatment due to systemic absorption. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. Application on large areas of damaged skin, or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for a referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Due to the content of calcipotriol, hypercalcaemia may occur. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the maximum daily dose of Enstilar (15 g) is not exceeded.

Enstilar contains a potent group III-steroid and concurrent treatment with other steroids on the same treatment area must be avoided. The skin on the face and genitals is very sensitive to corticosteroids. Enstilar should not be used in these areas. Instruct the patient in the correct use of the product to avoid application and accidental transfer to the face, mouth and eyes. Wash hands after each application to avoid accidental transfer to these areas as well as unintended drug absorption on the hands. If lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be discontinued.

When treating psoriasis with topical corticosteroids, there may be a risk of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period. Long-term use of corticosteroids may increase the risk of local and systemic adverse reactions.

Treatment should be discontinued in case of adverse reactions related to longterm use of corticosteroid. There is no experience with the use of Enstilar in guttate psoriasis. Enstilar contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes. Pregnancy and lactation: There are no adequate data from the use of Enstilar in pregnant women. Enstilar should only be used during pregnancy when the potential benefit justifies the potential risk. Caution should be exercised when prescribing Enstilar to women who breast-feed. The patient should be instructed not to use Enstilar on the breast when breastfeeding. Side effects: There are no common adverse reactions based on the clinical studies. The most frequently reported adverse reactions are application site reactions. Uncommon (≥1/1,000 to <1/100): Folliculitis, hypersensitivity, hypercalcaemia, skin hypopigmentation, rebound effect,

application site pruritus, application site irritation, application site pain (including application site burning). Not known (cannot be estimated from available data): Blurred vision, hair colour changes. Calcipotriol: Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, psoriasis aggravated, photosensitivity and hypersensitivity reactions, including very rare cases of angioedema and facial oedema. Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria. Betamethasone: Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia. When treating psoriasis with topical corticosteroids, there may be a risk of generalised pustular psoriasis. Systemic reactions due to topical use of corticosteroids are rare in adults; however, they can be severe. Adrenocortical suppression, cataract, infections, impaired glycaemic control of diabetes mellitus, and increase of intra-ocular pressure can occur, especially after longterm treatment. Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied onto large skin areas, and during long-term treatment. Precautions for storage: Do not store above 30°C. Extremely flammable aerosol. Pressurised container. May burst if heated.

Protect from sunlight. Do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use. Do not spray on an open flame or other ignition source. Keep away from sparks/open flames. No smoking. Legal category: POM. Marketing authorisation number and holder: PL 05293/0008 (UK), PA 1025/5/1 (Ireland). LEO Pharma A/S, Ballerup, Denmark. Basic NHS price (UK): £39.68/60 g, £79.36/2 x 60 g. Last revised: March 2021.

Reporting of Suspected Adverse Reactions Adverse events should be reported.

For the United Kingdom, reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adverse events should also be reported to Drug Safety at LEO Pharma by calling +44 (0)1844 347333 or e-mail: medical-info.uk@leo-pharma.com For the Republic of Ireland, reporting forms and information can be obtained from: HPRA Pharmacovigilance, Earlsfort Terrace, Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie.

Adverse events should also be reported to Drug Safety at LEO Pharma by calling +353 1 4908924 or e-mail: medical-info.ie@leo-pharma.com

References: 1. Enstilar® SPC, UK www.medicines.org.uk / IE www.medicines.ie. Last accessed: April 2021. 2. Leonardi C et al. J Drugs Dermatol 2015;14(12):1468–1477. 3. Koo J et al. J Dermatolog Treat 2016;27(2):120–127. 4. King C and Lowson D. Poster 237 presented at the 5th Psoriasis International Network Annual Meeting, Paris, France, 5–7 July 2016. 5. Lebwohl M et al. J Am Acad Dermatol 2020;doi: https://doi.org/10.1016/j.jaad.2020.09.037.

Further information can be found in the Summary of Product Characteristics or from: LEO Pharma, Horizon, Honey Lane, Hurley, Berkshire SL6 6RJ, UK. E-mail: medical-info.uk@leo-pharma.com LEO Pharma, Cashel Road, Dublin 12, Ireland. E-mail: medical-info.ie@leo-pharma.com ® Registered trademark

Date of preparation: April 2021 UK/IE MAT-43625 V2

Kind to skin. Kind to budgets.

Coming soon!

EPIMAX® Moisturising Cream A daily, all-purpose, replenishing moisturiser to soothe and relieve dry skin.

Everyday moisturisation Keeps dry skin at bay Skin feels soft

Recommend a range that gives your patients the choice they need:

✓ Save up to 61% vs. the best known emollient brands1 ✓ Similar formulations to the best-known emollient brands ✓ Fully recyclable 500g tottles (top-down bottles)* ✓ Free from SLS, parabens and perfumes

® www.epimax.co.uk Economise without compromise Epimax Range Product Information Presentation: Creams and gels available in a 500g Flexi-dispenser or 100g tube, ointments available in a 500g or 125g tub (Epimax Ointment only). Main ingredients: White soft paraffin, light liquid paraffin, anhydrous lanolin, Avena sativa (oat) kernel flour; Isopropyl myristate , yellow soft paraffin, Polyoxyethylene, hydrogenated castor oil. Indications: All products: As an emollient for the relief of dry skin in eczema, psoriasis and other dry skin conditions. Creams: For use as a soap substitute Gels: For the relief of dry or chapped skin which may also be itchy or inflamed. Ointments: Bath additive or soap substitute. Method of use: Adults, Elderly and Children: apply to the skin areas as frequently as required. As a soap substitute: Use as required instead of soap. As a bath additive: melt 4g in hot water and add to the bath. Dosage: Use as required. Warnings: Do not smoke or go near naked flames References:

– risk of severe burns. Fabric that has been in contact with these products burns more easily and is a serious fire hazard. Avoid contact with the eyes. Talk to your doctor or healthcare professional before use if the skin is broken, badly cracked, infected or bleeding. Contraindications: Patients with known hypersensitivity to any ingredient, including: Lanolin, Cetostearyl Alcohol, and Hydroxybenzoates, Phenoxyethanol, Isopropyl Palmitate and Benzyl Alcohol, Triethanolamine; Side effects: Rarely mild reactions such as skin rash can occur. Allergic reactions. Product classification: Class I Medical Devices. Cost: Epimax Moisturising Cream: £2.99 (500g), £1.99 (100g) [NHS Price List]; License holder: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK. Date reviewed: February 2021. Version number: 1010451581 v 6.0.

* Our 500g creams and gel formulations are packaged in tottles and our ointments in 500g tubs 1. https://www.mims.co.uk/ (accessed May 2021)

10104511214 v 1.0 May 2021 Always read the label

ASK THE PHARMACIST

How does crystacide under duoderm work for molluscum contagiosum?

Humans are the only host for molluscum contagiosum (MC), a double-strand DNA virus belonging to the poxviridae family.1 Although there are at least four different genotypes: MCV1, MCV2, MCV3 and MCV4, infection with MCV1 is the most common, accounting for 76-97% of all clinical isolates.2 MC is transmitted either by close contact or indirectly via fomites (i.e. from a contaminated surface) and is a very common skin condition, especially in children, with one UK-based study finding that 90% of cases occurred in children aged 0-14 years with an incidence rate of 1,265/100,000.3 The diagnosis is based on clinical symptoms and MC presents as umbilicated, smooth, flesh-coloured, dome-shaped lesions that occur on areas of the skin such as the trunk, extremities, intertriginous regions, genitals and face. Lesions are largely asymptomatic but can be pruritic, and there is some evidence to suggest that MC is more likely in children with atopic eczema.4 MC is a benign, self-limiting condition with one study including 306 children finding that the mean time to resolution of a lesion was 13.3 months, although in 13% of children, lesions were still present after 24 months. 5

Treatment The need for treatment is controversial given that most cases of MC will spontaneously resolve. In fact, one study of 170 children with MC observed that after 12 – 17 months, the extent www.bdng.org.uk

to which lesions completely cleared was similar between treated (23.9%) and untreated (24.2%) children.6 Nevertheless, many parents seek treatment, largely for cosmetic or social reasons, and interventions can be broadly categorised as either mechanical, e.g. cryotherapy and curettage, or chemical. There are a range of chemical treatments including potassium hydroxide, salicylic acid, tretinoin and cantharidin or immunomodulatory agents such as imiquimod. In a 2017 Cochrane review,7 it was concluded that “no single intervention has been shown to be convincingly effective in the treatment of molluscum contagiosum.”

Treatment with hydrogen peroxide Products containing hydrogen peroxide are available for the treatment and prevention of superficial skin infections.

The drug is used as an antiseptic agent in wound management and releases oxygen in the skin which contributes to its antimicrobial efficacy.8 The reason for the use of hydrogen peroxide as a treatment for MC is based on predominately in vitro evidence, indicating that many viruses such as swine flu, measles, rubella and rabies have been found to be sensitive to it.9 A further reason is the similarity in structure to benzoyl peroxide which, in a single study, was found to clear 90% of MC lesions.10 Moreover, current advice from the NHS recommends the use of benzoyl peroxide as a treatment for MC.11

The use of a twice-daily regime with 1% hydrogen peroxide cream (Crystacide) in MC was first reported in a 2003 study of 12 patients (mean age 18 years).12 After 21 days, eight patients experienced complete clearance of lesions, and in the remaining four a 70% reduction in lesion count was observed.

Additionally, all patients were followedup for six months, during which time there was no recurrence of lesions.

The use of a 1% hydrogen peroxide cream under occlusion was reported in a single case study of an eight-month-old girl with MC lesions in the genital area.13 The parents were advised to apply the hydrogen peroxide cream after every nappy change for at least a week, and this led to a significant improvement in symptoms. While the mode of action of hydrogen peroxide is unclear, the authors suggested that it might be due to blockage of a specific MC protein. For example, it is known that MC encodes for more than 150 proteins, some of which might contribute to prolonged viral replication within the skin. MC66 is a selenocysteine containing protein produced by MC and which protects the virus against peroxide-induced damage.14 It is therefore possible that hydrogen peroxide is able to overcome the activity of MC66, hence resulting in viral death. The use of hydrogen peroxide under occlusion was explored in a more recent study, in which 21 immunocompetent children with a mean age of 5.3 years, applied a 1.8%

Dermatological Nursing, 2021, Vol 20, No 2

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ASK THE PHARMACIST hydrogen peroxide gel twice daily to MC lesions for 21 days.15 Complete remission of lesions only occurred in three patients and lesion counts decreased in the majority of other children, yet the number actually increased in three patients. While in both studies the occlusive agent was not disclosed, duoderm is a hydrocolloid dressing with an outer film which forms a waterproof barrier over a wound and could therefore serve as a suitable covering.

In summary, while there is some, albeit limited, evidence to support the use of hydrogen peroxide in the treatment of MC, especially under occlusion, at the present time, whether or not duoderm represents the most suitable occlusive dressing remains unclear. DN

References 1. Meza-Romero R, Navarrete-Dechent C, Downey C. Molluscum contagiosum: an update and review of new perspectives in etiology, diagnosis, and treatment. Clin Cosmet Investig Dermatol 2019.

12:373-81

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2. Trcko K, Hosnjak L, Kusar B, Zorec TM, Kocjan BJ, Krizmaric M, et al. Clinical, Histopathological, and Virological Evaluation of 203 Patients With a Clinical Diagnosis of Molluscum Contagiosum.

Open Forum Infect Dis 2018. 5(11):ofy298 3. Pannell RS, Fleming DM, Cross KW. The incidence of molluscum contagiosum, scabies and lichen planus. Epidemiol Infect 2005. 133(6):985-91 4. Olsen JR, Piguet V, Gallacher J, Francis NA. Molluscum contagiosum and associations with atopic eczema in children: a retrospective longitudinal study in primary care. Br J Gen Pract.

2016. 66(642):e53-8 5. Olsen JR, Gallacher J, Finlay AY, Piguet V, Francis NA. Time to resolution and effect on quality of life of molluscum contagiosum in children in the UK: a prospective community cohort study. The Lancet Infectious Diseases 2015.

15(2):190-5

and cutaneous biology: Translational applications, benefits, and risks. J Am Acad Dermatol 2019.

81(6):1379-86 9. Caruso AA, Del Prete A, Lazzarino AI. Hydrogen peroxide and viral infections: A literature review with research hypothesis definition in relation to the current covid-19 pandemic. Med Hypotheses 2020. 144:109910 10. Saryazdi S. The comparative efficacy of benzoyl peroxide 10% cream and tretinoin 0.05% cream in the treatment of molluscum contagiosum. Pediatric Dermatol 2004. 21:399 11. NHS. Molluscum contagiosum treatment 2021 [May 2021]. Available from: https://www.nhs.uk/ conditions/molluscum-contagiosum/treatment/ [last accessed June 2021] 12. Bigardi A MM. Successful treatment of molluscum contagiosum skin infection with hydrogen peroxide 1% cream. JEADV 2003. 17:419

6. Basdag H, Rainer BM, Cohen BA. Molluscum contagiosum: to treat or not to treat? Experience with 170 children in an outpatient clinic setting in the northeastern United States. Pediatr Dermatol 2015. 32(3):353-7

13. Semkova K, Palamaras I, Robles W. Hydrogen peroxide 1% cream under occlusion for treatment of molluscum contagiosum in an 8-month-old infant: an effective and safe treatment option. Clin Exp Dermatol 2014. 39(4):560-1

7. van der Wouden JC, van der Sande R, Kruithof EJ, Sollie A, van Suijlekom-Smit LW, Koning S. Interventions for cutaneous molluscum contagiosum. Cochrane Database Syst Rev 2017.

5:CD004767

14. Moss B SJ, Xiang Y et al. Immune-defense molecules of molluscum contagiosum virus, a human poxvirus. Trends Microbiol 2000. 8:473-7

8. Murphy EC, Friedman AJ. Hydrogen peroxide

Dermatological Nursing, 2021, Vol 20, No 2

15. Schianchi R, Nazzaro G, Veraldi S. Treatment of molluscum contagiosum with hydrogen peroxide. Clin Exp Dermatol 2018. 43(1):66-7

www.bdng.org.uk

NOW LICENSED FOR PSORIATIC ARTHRITIS (PsA) AND PSORIASIS (PsO)1

LIFE IS

demonstrated sustained relief in psoriatic arthritis* out to 1 year and psoriasis† out to 5 years2-4

Tremfya® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.1

*Sustained improvements in psoriatic arthritis disease severity (as measured by ACR scores, HAQ-DI scores and resolution of enthesitis and dactylitis). †Sustained improvements in psoriasis disease severity (as measured by PASI 90 scores) Adverse events can be found in the prescribing information below.

Please refer to the Tremfya® Summary of Product Characteristics for the full safety information before prescribing.1

Tremfya® is indicated in the treatment of active psoriatic arthritis in adult patients, alone or in combination with methotrexate, who have had an inadequate response or have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.1 ACR20 improvements in the DISCOVER clinical trials: DISCOVER-2: At Week 24: Full analysis set: 64% for Tremfya® q8w (n=248) vs 33% for placebo (n=246; p<0.0001). At Week 52: NRI population. 74.6% for Tremfya® q8w (n=248). DISCOVER-1: At Week 24: Full analysis set: 52% for Tremfya® q8w (n=127) vs 22% for placebo (n=126; p<0.0001). At Week 52: NRI population. 59.8% for Tremfya®q8w (n=127).3-6 PASI 90 response at Week 252 in the VOYAGE 1 clinical trial (NRI through Week 48, TFR beyond): 84.1% for Tremfya® SC q8w (n=391).2

References: 1. Janssen-Cilag Ltd. Tremfya® Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/medicine/34321. Accessed January 2021. 2. Griffiths C, et al. Maintenance of Response Through 5 Years of Continuous Guselkumab Treatment: Results From the Phase 3 VOYAGE 1 Trial. Presented at the 16th Annual Coastal Dermatology Symposium. October 15-16, 2020 New Jersey, USA. 3. McInnes IB, et al. Arthritis Rheumatol. 2020 Oct 11. doi: 10.1002/art.41553. 4. Ritchlin C, et al. Guselkumab, an IL-23 Inhibitor That Specifically Binds to the IL23p19-Subunit, for Active Psoriatic Arthritis: One Year Results of a Phase 3, Randomized, Double-blind, Placebo controlled Study of Patients who Were Biologic-Naïve or TNFa Inhibitor- Experienced. Presented at EULAR 2020.

5. Mease PJ, et al. Lancet 2020;395:1126-1136. 6. Deodhar A, et al. Lancet. 2020;395:1115-1125.

DISCOVER-1 was a multicentre, double-blind, randomised, placebo-controlled, Phase 3 trial enrolling adults with active PsA. About 30% of study participants could have previously received one or two TNF inhibitors.5 DISCOVER-2 was a multicentre, double-blind, randomised, placebo-controlled, Phase 3 trial in bio-naive patients with active PsA.6 VOYAGE 1 was a multicentre, double-blind, randomised, placebo- and active comparator-controlled study in patients with moderate to severe plaque psoriasis.2 PsO, psoriasis; PsA, psoriatic arthritis; HAQ-DI, Health Assessment Questionnaire Disability Index; TNF, tumour necrosis factor; TFR, treatment failure rules; PASI, Psoriasis Area Severity Index; NRI, non-responder imputation; SC, subcutaneous; ACR20, 20% improvement in the American College of Rheumatology Score.

TREMFYA® ▼ 100 mg solution for injection in pre-filled pen PRESCRIBING INFORMATION ACTIVE INGREDIENT(S): Guselkumab Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S): Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Treatment of active psoriatic arthritis in adult patients, alone or in combination with methotrexate, who have had an inadequate response or have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. DOSAGE & ADMINISTRATION: For use under guidance/supervision of physician experienced in diagnosis and treatment of conditions for which Tremfya is indicated. Subcutaneous injection. Avoid areas showing psoriasis. Adults: For both indications,100 mg at weeks 0 and 4, followed by maintenance dose every 8 weeks. In the case of psoriatic arthritis, for patients at high risk for joint damage according to clinical judgement, consider a dose of 100 mg every 4 weeks. Consider discontinuation if no response after 16 weeks of treatment for plaque psoriasis and after 24 weeks for psoriatic arthritis. Children: No data available in children/adolescents <18 years. Elderly: No dose adjustment required, limited information in subjects aged ≥ 65 years, very limited information > 75 years. Renal & Hepatic impairment: Not studied. CONTRAINDICATIONS: Serious hypersensitivity to active substance or excipients; clinically important, active infection. Refer to SmPC for full list of excipients. SPECIAL WARNINGS & PRECAUTIONS: Infections: Potential to increase risk. If signs/symptoms of clinically important chronic/acute infection occur, monitor closely and discontinue Tremfya until resolved. Tuberculosis: Evaluate patients for TB pretreatment; monitor for

Job code: CP-211964 Date of preparation: February 2021

signs/symptoms of active TB during and after treatment. Consider anti-TB therapy prior to Tremfya if past history of latent/active TB and adequate treatment course not confirmed. Serious hypersensitivity reaction: Includes anaphylaxis. Some serious hypersensitivity reactions occurred several days after treatment and included urticaria and dyspnoea. If occurs, discontinue Tremfya immediately and initiate appropriate therapy. Hepatic Transaminase Elevations: An increased incidence of liver enzyme elevations has been observed in patients treated with Tremfya q4w compared to patients treated with Tremfya q8w or placebo. When prescribing Tremfya q4w in psoriatic arthritis, consider evaluating liver enzymes at baseline and thereafter according to routine patient management. If increases in ALT or AST are observed and drug-induced liver injury is suspected, Tremfya should be temporarily interrupted until this diagnosis is excluded. Immunisations: Consider completing all appropriate immunisations prior to Tremfya. Do not use live vaccines concurrently with Tremfya; no data available; before live vaccination, withhold Tremfya for at least 12 weeks and resume at least 2 weeks after vaccination. SIDE EFFECTS: Very common: Respiratory tract infection. Common: headache, diarrhoea, arthralgia, injection site reactions, transaminases increased. Other side effects: hypersensitivity, anaphylaxis, rash, gastroenteritis, herpes simplex infections, tinea infections, neutrophil count decreased, urticaria. Refer to SmPC for more detail on side effects. PREGNANCY: Avoid use of Tremfya; no data. Women of childbearing potential should use effective contraception during and for at least 12 weeks after treatment. LACTATION: It is unknown whether guselkumab is excreted in human milk. A decision should be made to discontinue, or abstain from initiating treatment with Tremfya taking

© Janssen-Cilag Limited 2021

into account the benefit of breast-feeding to the child and the benefit of Tremfya therapy to the woman. INTERACTIONS: No dose adjustment when co-administering with CYP450 substrates. Concomitant immunosuppressive therapy or phototherapy not evaluated. Refer to SmPC for full details of interactions. LEGAL CATEGORY: Prescription Only Medicine (POM) PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S) & BASIC NHS COSTS PRESENTATIONS

PACK SIZES

MARKETING AUTHORISATION NUMBER(S)

BASIC NHS COSTS

Pre-filled pen (100mg)

X1

EU/1/17/1234/002

£2250

MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK. Prescribing information last revised: November 2020 This medicinal product is subject to Adverse events should be reported. additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com.

Clear the way to a bright future

EASY CHOICE, LASTING CHANGE 5 reasons to make ILUMETRI® your IL-23 of choice for patients with moderate-to-severe psoriasis 4x

CONFIDENCE IN SUSTAINED EFFICACY for up to 5 years.1

IMPROVED QUALITY OF LIFE with more than 50% of patients (W28 responders) reporting that psoriasis no longer affected their lives after just 3 injections (DLQI 0/1 in 52% of n=299 patients).2

CONSISTENT, FAVOURABLE SAFETY PROFILE confirmed by 5-year data, with low rates of AEs of special interest,* including severe infections, malignancies and MACE.1

CONVENIENT DOSING SCHEDULE with only 4 injections per year during maintenance and flexible dosing to adapt to patient needs.3

MORE COST EFFECTIVE than other biologics,4† with flat pricing across doses.5

ILUMETRI®: UP TO 5 YEARS OF PROVEN PSORIASIS CONTROL FROM AN IL-231 AE, adverse event. DLQI, Dermatology Life Quality Index. IL, interleukin. MACE, major adverse cardiovascular events. W, week. *AEs of special interest also included malignancies, non-melanoma skin cancer, injection site reactions and drug-related hypersensitivity reactions.1 † When assessed at Week 28, compared with other targeted treatments that are usually assessed between 12 weeks and 16 weeks (such as brodalumab, guselkumab, ixekizumab, infliximab and secukinumab).4 Prescribing Information Please consult the Summary of Product Characteristics (SmPC) before prescribing. ▼ ILUMETRI® 100 mg solution for injection in pre-filled syringe.

Active Ingredient: Each pre-filled syringe contains 100 mg of tildrakizumab in 1 ml. Tildrakizumab is a humanised IgG1/k monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Indication: ILUMETRI is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Dosage and Administration: The recommended dose of ILUMETRI is 100 mg by subcutaneous injection at weeks 0, and 4 and every 12 weeks thereafter. In patients with certain characteristics (e.g. high disease burden, body weight ≥ 90 kg) 200 mg may provide greater efficacy. Consideration should be given to discontinuing treatment in patients who have shown no response after 28 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 28 weeks. Injection sites should be alternated. Elderly: No dose adjustment is required. Paediatric population: No data available. Renal or hepatic Impairment: No dosage recommendations can be made. Consult SmPC and package leaflet for full method of administration. Contraindications, Precautions and Warnings: Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in SmPC section 6.1. Clinically important active infection, e.g. active tuberculosis. Precautions: In order to improve traceability always record the batch number of the administered product. ILUMETRI may have the potential to increase the risk of infections. If a patient develops a serious infection, the patient should be closely monitored and treatment with ILUMETRI should not be administered until the infection resolves. Exercise caution in patients with a chronic infection or a history of recurrent or recent serious infection. Instruct patients to seek medical advice if signs or symptoms of an infection occur. Patients should be evaluated for tuberculosis (TB) prior to initiation of treatment and monitored for signs and symptoms of active TB during and after treatment. In patients with a past history of latent or active TB, consideration for anti-TB therapy should be given. Discontinue use if a serious hypersensitivity occurs. All appropriate immunisations should be completed prior to start of treatment with ILUMETRI. Patients treated with ILUMETRI should not receive live vaccine during treatment and for at least 17 weeks after treatment. Consult SmPC and package leaflet for more information. Fertility, pregnancy and lactation: Women of childbearing potential should use effective methods of contraception during treatment and for 17 weeks after treatment. As a precautionary measure, it is preferable to avoid the use of ILUMETRI during pregnancy. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ILUMETRI therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for

the woman. The effect of ILUMETRI on human fertility has not been evaluated. Consult SmPC and package leaflet for more information. Adverse Reactions: Very common (≥1/10):Upper respiratory tract infections, including nasopharyngitis. Common (≥1/100 to <1/10): Headache, gastroenteritis, nausea, diarrhoea, injection site pain, back pain.

Consult SmPC and package leaflet for further information. Legal Category: Ireland: Subject to prescription which may not be renewed (A). United Kingdom: POM Price: United Kingdom: UK NHS Cost: (excluding VAT). 1 x 100 mg solution in a pre-filled syringe - £3,241 2 x 100 mg solution in a pre-filled syringe - £3,241 Marketing Authorisation Number(s): EU/1/18/1323/001 EU/1/18/1323/002 Further information available from: Almirall Limited, Harman House, 1 George Street, Uxbridge, Middlesex, UB8 1QQ, UK. Date of Revision: 05/2020 Item code: IE-ILU-2000011

UK-Adverse events should be reported.

Reporting forms and information can be found at MHRA https://yellowcard.mhra.gov.uk Adverse events should be also reported to Almirall Ltd. Tel. 0800 0087 399

IE-Adverse events should be reported.

Reporting forms and information can be found at HPRA Website: www.hpra.ie, email: medsafety@hpra.ie Adverse events should be also reported to Almirall Ltd. Tel. +353 (0) 1431 9836 References 1. Thaçi D, et al. Br J Dermatol 2021;10. DOI: 10.1111/bjd.19866. 2. Reich K, et al.

Lancet 2017;15:276–288. 3. ILUMETRI® Summary of Product Characteristics.

Almirall. 4. NICE. Tildrakizumab for treating moderate to severe plaque psoriasis.

Available at: https://www.nice.org.uk/guidance/ta575. 5. ILUMETRI® MIMS. Available at: https://www.mims.co.uk/drugs/skin/psoriasis-seborrhoeaichthyosis/ilumetri.

Discover more at almirallmed.co.uk

February 2021 UK-ILU-2100006

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PATIENT VOICE

Ichthyosis during a pandemic Amy Probert

A

s a brief introduction, I’m Amy and I live with my partner Mark, who is the daddy of our three children, Kaydon (8), Isabella (5) and Poppy-Rose (4). Poppy made her dramatic entrance to the world at 32+5 weeks and has harlequin ichthyosis.

As you can imagine, life with three children close in age is more than hectic at times, especially factoring in appointments and the skin care regime that is part of being an ‘ichthy family’.

For many of us, life changed dramatically back in March 2020, so I’d like to give an insight into what life has been like for our family over during the COVID-19 crisis.

Initially, my concern was medical supplies. So many worries about being unable to receive prescription items as everybody began to stockpile and GPs were inundated with requests. And let’s not forget the great toilet roll shortage of 2020, which just so happened to coincide with when Poppy decided that she would toilet train herself overnight!

We also had moments where we needed access to urgent medical care from our GP and dermatology team – both of which were managed via telephone and were reassuringly very effective. At this point, I’d love to extend my enormous thanks to our dermatology team and GP/pharmacy.

Another hurdle was the shortage of PPE, as we use gloves as part of our care regime. This was a stressful time as Poppy had suffered a skin infection prior to lockdown and gloves for us were part of infection control. Thank you to family and friends who pulled together to donate or help us to source gloves.

Moving on from the worries surrounding daily care came the overwhelming anxiety and fear of the www.bdng.org.uk

Not everything about lockdown was difficult. It gave us time as a family to pause and spend time together unknown; something that a lot of parents of children with ichthyosis are more familiar with than most. From the day our children were born, we were often told the words: “We just don’t know”.

Coupling that with the unknowns from a global pandemic increased anxiety in many parents whose children have ichthyosis I had spoken to.

Poppy’s prematurity meant that her lungs were not as developed as children born full term. Although her sevenweek neonatal unit stay was relatively uneventful, her exposure to viruses preCOVID meant that her first three years were spent in and out of hospital due to respiratory infections. Poppy required support via oxygen, feeding tubes and

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PATIENT VOICE

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treatment for extreme fevers which has left her with anxiety in everyday life.

For me as a parent, COVID-19 raised a lot of past trauma and it wasn’t long before we noticed this had affected Poppy’s anxiety too. The period at home was also when she realised that she is different and started to talk to us about this.

However, not everything about lockdown was difficult. It gave us time as a family to pause and spend time together. We no longer had to juggle school runs and appointments at hospitals far away. Appointments could be done at home, which also gave Poppy respite from her medical anxieties, allowing time for her confidence to grow.

Video consultations led to moments I wanted to crawl into a pit and hide as Poppy discovered a real chance to show off some colourful language and tell stories of what she saw on TikTok. One of my favourites was when I had to explain to a CAMHS representative who Joe Exotic and Carole Baskin were whilst sugar-coating the whole story!

Poppy also does a great impression of Eastenders’ Phil Mitchell and is generally hilarious in her one-line replies and nicknames for our neighbours, including “Noisy Turds” and “Smokey Man”. If you are on my social media, you will know Poppy’s personality…

We had summer days filled with baking, painting, crafts and days in the paddling pool; you name it, we tried it. One of the nicest things to see was the relationship between the children.

Kaydon and Isabella are so understanding of Poppy’s needs and anxieties. For example, they helped her when she was struggling to climb onto the trampoline or in and out of the pool, but before long, she had mastered it herself.

Isabella and Poppy often disappeared together and Poppy emerged with a new hairstyle and nail varnish. Kaydon play fights with Poppy and I always know where they are in the house from the ridiculously loud squeals and laughter.

Then there’s our dog, Skye, who helps the children in ways she will never know.

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She is best friend to all three and helps them all with the various emotions being a ‘different’ family can bring. She was always by their side getting covered in paint, cake mix and loved a water fight in the garden.

and more applications of emollients (although this could all have been due to the weather conditions, as these also affect her skin cycle). This also made the decision for her to return to her nursery setting a little bit easier for us.

Fast forward to February this year, we all caught COVID. Thankfully, however, we all recovered at home.

As there is still much curiosity and concern for those with severe skin disorders, I thought it would be useful to mention that Poppy coped very well, as did her brother and sister in terms of symptoms. The biggest tell-tale sign that she was ill was the extremely dry and flakey skin. Afterwards, it did take a while for her skin to recover, and she required a longer bathing routine

Before the pandemic, Poppy attended a nursery placement, but because of her crippling anxiety it did not go well for her. She was so scared to be away from me that she would be physically sick – even at two years old she was experiencing panic attacks and extreme anxiety.

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When COVID arrived in the UK, we made the decision to pull Poppy out of nursery until we felt it was safer, and she returned in March this year. This www.bdng.org.uk

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PATIENT VOICE

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begin to accept herself for who she is and to grow the confidence to realise her self-worth.

Poppy is so effortlessly funny without even realising, and her lack of a filter makes her even funnier. Things that most of us think but don’t say will come out of her mouth. She announced to nursery that she can’t share her Easter chocolate with her dad because his tummy is too big already, and also happily shouted out of the window at our neighbour to ‘shut up’ when they were yelling in the street!

She loves toilet humour and is always making up her own songs – although I’m not sure her most famous one is appropriate to mention here. Also, now part of our vocabulary are the terms ‘badheart’ and ‘goodheart’ – whether someone has annoyed you or not and you like/dislike them in that moment. break has done wonders for Poppy’s confidence and has far exceeded any potential expectations we might have had. We have been fortunate to find a (mainstream) nursery who have embraced Poppy and her quirks, and have supported her and enabled her to grow. They have involved us in everything and invited me to their staff meeting to give a talk to staff and answer any questions they had. This was so important for us and helped them to see Poppy beyond her skin whilst helping them to feel confident in her care too.

The year out also prompted the start of Poppy’s journey of selfacceptance of having ichthyosis. She often told us that she doesn’t want ichthyosis and was frequently rejecting elements of her care. As members of the fabulous Ichthyosis Support Group (ISG) we have met and spoken to

As members of the fabulous Ichthyosis Support Group (ISG) we have met and spoken to people with ichthyosis from the UK, Australia and America, and Poppy loves to see people who are like her people with ichthyosis from the UK, Australia and America, and Poppy loves to see people who are like her. Social media has been an amazing tool to help show her that she is not alone, and that other people have ichthyosis too; they grow up and have friends, jobs and families. She now wants to work with dogs when she’s older. We have also become great friends with other families, and we all offer advice and support to one another in our times of need. All this seems to have helped her

All in all, we are a relatively ‘normal’ family with some beautifully exceptional children. There will always be good and bad days, which can be said for any family. Perhaps sometimes our experiences from ichthyosis can bring more challenges, but as long as you can enjoy the little moments together, you will always have amazing memories. Life as an ichthy family is beautiful and we are so very blessed to be a part of such a great community.

Take care of yourselves and as Poppy would say, ‘smell ya later!’ DN More information about the Ichthyosis Support Group can be found online at: www.ichthyosis.org.uk.

Alternatively, you can call 0845 602 9202 or email isg@ichthyosis.org.uk.

Our premium, silky smooth menthol in aqueous cream SKIN DEEP SOOTHE ABILITY Request your free Menthoderm® sachets from menthodermsachets.co.uk www.bdng.org.uk

MEN/135/0520 Date of Preparation: May 2020

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BDNG NEWS

UK DCTN update Carron Layfield Update on recruiting trials All studies below are funded by National Institute for Health Research (NIHR) funding streams.

SAFA Only 110 more participants needed by end of August 2021 for this adult female acne study The SAFA (Spironolactone for Adult Female Acne) randomised controlled trial (RCT) has now recruited 288/398 participants, including 161 since the first clinic post lockdown in July 2020.

Advertising through social media remains crucial in identifying potential participants quickly. Ten secondary care sites are actively involved in recruitment (Birmingham, Bristol, Cardiff, Epsom, Harrogate, Nottingham, Swansea, St Mary’s London, Poole, and Portsmouth) and the study team are optimistic the new target of 398 participants (revised down from 434) will be met by the recruitment end date of 31st August 2021. Please see the study website for a full update: https://www.southampton. ac.uk/safa/index.page.

THESEUS HS study recruits 100+ patients with recruitment end date extended to June 2021 THESEUS – a prospective cohort study aiming to identify the best treatment options for hidradenitis suppurativa (HS) when first line treatment fails – has recruited robustly despite the pandemic, and has now reached 109/150 recruits.

Ten sites are now open (Stoke Mandeville, Oxford, Forth Valley, Chelmsford, Newcastle, Cardiff, Barnsley, Guy’s and St Thomas, Salford and Brighton), with the recruitment period extended to the end of June 2021.

Interviews with study participants about their experiences are going well, 58

and the de-roofing procedure video has now had over 475,000 views.

For further information please see the new study website at: https://www. nottingham.ac.uk/research/groups/cebd/ projects/5rareandother/theseus.aspx.

ALPHA Just 20 more patients needed for this hand eczema study ALPHA, an RCT comparing the effectiveness of alitretinoin and PUVA for the treatment of severe hand eczema, now needs just 20 patients to meet the final target of 455 participants.

Patients can self-refer – please see the website https://ctru.leeds.ac.uk/ alpha (which includes a list of the 20+ recruiting centres) for full details.

Other news UK DCTN 2021 Themed Call – Paediatric Dermatology, closing date Mon 19th July This year, three themed call awards of up to £10,000 each are available thanks to co-funding from the British Society of Paediatric Dermatology (BSPD) and the National Eczema Society (NES).

The closing date for applications is Monday 19th July, with full information available at http://www.ukdctn.org/ funding-awards/ukdctn-funding-awards. aspx. Nurse-led applications are welcomed, and if you would like to discuss informally before submitting please get in touch with Network Manager at carron. layfield@nottingham.ac.uk.

Exploring training and development needs Many thanks to those BDNG members who joined us at the online meeting on 14th April to explore clinical research training and development needs in dermatology nursing. Following these discussions, a research section has been

Dermatological Nursing, 2021, Vol 20, No 2

added to the resources area of the BDNG website, and as a starting point this includes links to further websites and free of charge online courses.

The next webinar, which will discuss the article in this edition exploring different approaches to clinical research, will be held on Wednesday 14th July at 7.00pm – please do join us to discuss and find out more about why different types of clinical research are used to answer different research questions.

UK DCTN Nurse or Pharmacist Fellowship Award After a pause due to COVID-19, the UK DCTN Fellowship Awards are back this year. The nurse fellowship is now a joint award (with pharmacists) and the eligibility criteria has been changed to open it out to a wider range of dermatology nurses (you no longer need to be involved in research to apply).

The two-year award has £1,750 allocated to cover expenses for several activities including: the BEES Better Evaluation of Evidence and Statistics course, spending time at the UK DCTN Co-ordinating Centre in Nottingham, working on critical appraisal skills with Prof Hywel Williams (UK DCTN Chair) and joining our Steering Committee.

It’s easy to apply for the Fellowship Award, with the process consisting of a short application form and there are no interviews. All awards are judged solely on the applications received. The closing date is Monday 25th October. For more information see http://www.ukdctn.org/ ukdctn/awards-and-training/index.aspx.

Membership of the UK DCTN is free.

If you have an interest in dermatology research sign up at www.ukdctn.org. DN Corresponding author: Carron Layfield. Tel 0115 8468625, e-mail carron.layfield@nottingham.ac.uk www.bdng.org.uk

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PODCAST

Taking the BDNG into the world of podcasts Emmanuel Toni, Aisling Clery

O

ne of the innumerable lessons the recent COVID pandemic has taught us is that we must be adaptive in our approach to nursing education and how we disseminate information. Podcasts are an audio format which allow people to listen and learn in their own time. They are now widely available on most audio platforms including Spotify, iTunes, YouTube, and more. The COVID pandemic has forced much historic face-to-face teaching online, and so podcasts represent a viable bridge to this educational need.

Additionally, some estimate that around 38.7 million of the British public have listened to at least one podcast over the last year with projections showing increasing numbers over the coming years. This shows a growing potential demand for such resources.

The BDNG approached us to help establish a podcast given our previous experience with DermatologyUKThePodcast. We are both Dermatology Clinical Nurse Specialists; Aisling Clery at Guys and St Thomas’s NHS Foundation Trust and I (Emmanuel Toni) at The Royal Free NHS Foundation Trust.

We had numerous questions prepared for our initial meeting. To begin with, who was the target audience?

When developing digital content, it is vital to know who will be listening as this

strongly influences your approach. The BDNG expressed they were keen to create a viable podcast that could be used by healthcare professionals with an interest in dermatology to access highquality and reliable information.

We established what the expectations were around the tonal approach (formal vs informal); what topics we were going to cover and how long each episode would last. It was decided that the podcast would have a more formal approach and achieve an average 30-minute duration per episode.

Though we had initial concerns around crossover with our own podcast, it was clear that the approach was different and so it was felt that there would be no conflict of interest.

In addition, we discussed logistical issues such as which platforms the podcast would be available on and who would have access. Another key consideration was content, and we have recorded – and are in the process of recording – episodes with a huge variety of professionals throughout the UK.

projects such as the Dermatology Nursing Role Descriptions Project.

We hope this episode will empower nurses to use this resource to benefit their career progression and to act as a useful tool during discussions with colleagues/management on current roles.

Furthermore, we discussed visions for the future for dermatology nursing, a topic we hope the listeners will find riveting.

Another episode we had the pleasure of recording was with Julia Wheeler, Educational Development Nurse for the BDNG, and Holly Nagle, a member of the nursing support team, about being redeployed during the COVID-19 pandemic. We reflect on their personal experiences and the strengths they brought to their deployed role. In addition, we touch on the impact of stress and what new skills they have brought back to their department with them.

The final episode we will mention is with Consultant Nurse Lucy Moorhead and Dermatology Service Team Lead for Sirona Care and Health Lynne Skrine. Here we discuss the impact of COVID-19 on services.

DermaExchange

For example, we were given the opportunity to talk with Consultant Nurse Karina Jackson regarding the collaborative BAD and BDNG education nursing work stream. Karina was able to share context on the workstream’s goals and we were able to discuss exciting

DermaExchange

We hope you find the podcasts enjoyable to listen to and educational at the same time.

DermaExchange

Happy Listening!

DN

The space for new ideas in dermatology DermaExchange

At DermaExchange, you can discover high-quality educational content from leading dermatologists and enjoy open discussions with fellow professionals.

Register for the latest webinars and catch up with recorded events from our archive.

Start exploring today at dermatology.almirallmed.co.uk/dermaexchange feel the science

www.bdng.org.uk

Website contains promotional material

IE-NOP-2100049 June 2021

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BDNG NEWS

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Annual Conference The BDNG is delighted to be holding our postponed 30th Annual Conference on 21 – 23 September 2021 in Harrogate Convention Centre.

Programme

(Please note: this programme is subject to change.)

Tuesday 21 September 11:00 – 13:00

BADBIR session

13:00 – 14:00

Lunch and Exhibition

14:00 – 17:00

Innovations in dermatology nursing

17:00 – 18:00

Welcome drinks reception

Wednesday 22 September Workshop

Foundation Stream

Advanced Stream

09:00 – 10:30 Communication skills

08:45 Welcome

08:45 Welcome

09:00 Immunology and biologics 09:00 What is advanced practice?

09:45 Lower leg dermatology

09:45 The Nurse Consultant journey

14:45 Introduction to allergy

14:45 Making your case for advanced nurse role

10:30 Coffee and Exhibition 11:00 AGM 12:10 Sponsored symposia 12:55 Lunch and Exhibition 13:55 Sponsored symposia 14:45 Appraisal of evidence workshop

15:15 Nurse Registrar role 15:45 Career development

15:45 Education in advanced practice

Workshop

Foundation Stream

Advanced Stream

09:15 Lesion recognition workshop

09:15 Welcome

09:15 Welcome

19:30 BDNG 30th birthday party

Thursday 23 September

09:30 Communicating with adolescents 09:30 Skin and gut microbiome 10:00 Blistering conditions

10:00 Cases in contact dermatitis

11:00 Photodermatoses

11:00 Oncology and melanoma

14:15 Treating scalp conditions

14:15 New developments in Biologics

10:30 Coffee and Exhibition 11:50 Sponsored sympsosia 12:35 Lunch and exhibition 13:25 Sponsored symposia 15:15 Conference close

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BDNG NEWS

Sponsors of

Registration fees

Awards Full conference

One day

Before 20 August

After 20 August

BDNG member

£199

£249

£99

£149

Non member

£249

£299

£149

£199

A £6 booking fee will apply to all registrations

Registrations are now open at: https://bdng.org.uk/bookings/ Members will have received an email with a discount code to secure the above rates. If you haven’t received this, please contact us at admin@bdng.org.uk or 02890511402

Conference Awards To mark our 20th Annual Conference, we are offering 30 Conference Awards of £500 each. You need to have been a member for at least one year and not have received a BDNG award in the last two years. These awards can only be used to attend the BDNG Annual Conference. Apply online at https://bdng.org.uk/awards/conference/ You will need to include a summary of 300 words outlining: Which elements of the programme interest you How this will impact on your practice/professional development giving examples How will you share information with your team/colleagues giving examples

Stone Achievement Award We invite nominations for our prestigious Stone Achievement Award. This Award is the BDNG’s way or recognising the work of an individual who have made a consistently great contribution in the field of dermatological nursing. More information is available at https:// bdng.org.uk/awards/stone/ Closing date is 20 August 2021.

Team of the Year Award The last two years has taught us all about the importance of teamwork.

Self-nominate your team for the Team of the Year Award at https:// bdng.org.uk/awards/team/ Closing date is 20 August 2021.

Accommodation HotelMap will be dealing with your hotel accommodation needs.

Booking can be made online at https://bdng.org.uk/annualconference-hotels-2021/

The closing date for applications is 6 August 2021

Call for abstracts The BDNG invites healthcare professionals to submit abstracts for oral and poster presentations. We would be particularly interested in submissions on all aspects of how COVID-19 has affected your clinical and professional practice.

Submit your abstract at https://bdng.org.uk/annual-conference-abstracts/ Closing date is 31 July 2021

Social events We will be holding a welcome drinks reception on Tuesday evening immediately following the end of the educational sessions. Come along to meet with colleagues old and new. No ticket is required for this event.

To celebrate our 30th Annual Conference we will be holding a birthday party on Wednesday evening. Following feedback this will be an informal event and the cost is included in your delegate fee. Food and drinks will be served and there will be entertainment.

Please note, COVID-19 restrictions may alter these events.

www.bdng.org.uk

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THE WATERPROOF STEROID TAPE Effectively treats inflammatory dermatoses, including hand eczema and finger tip fissures1. Good news for patients especially with increased handwashing situations.

Previously called Haelan tape

Easy to use on joints and awkward areas to allow patient mobility without disturbing the dressing.

Fludroxycortide Tape S T E R O I D I M P R E G N AT E D TA P E

For both children and adults

UNIFORM METERED DOSE AVAILABLE IN 2 PACK SIZES

Scan the QR code to view the application video.

Alternatively visit typharm.com or call 01603 722480 for more information Typharm Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk, NR13 6LH. UK

1/FT/12/2104/506 Date of preparation: May 2021

1. Layton A. Reviewing the use of Fludroxycortide tape (Haelan Tape) in Dermatology Practice. Typharm Dermatology.

Abridged Prescribing Information Fludroxycortide 4 micrograms per square centimetre Tape See Fludroxycortide Tape Summary of Product Characteristics (SmPC) prior to prescribing. Presentation: Transparent, plastic surgical tape impregnated with 4 µg/cm2 fludroxycortide. Indications: Adjunctive therapy for chronic, localised, recalcitrant dermatoses that may respond to topical corticosteroids and particularly dry, scaling lesions. Posology and Method of Administration: Adults and the Elderly: For application to the skin, which should be clean, dry and shorn of hair. In most instances the tape need only remain in place for 12 out of 24 hours. The tape is cut so as to cover the lesion and a quarter inch margin of normal skin. Corners should be rounded off. After removing the lining paper, the tape is applied to the centre of the lesion with gentle pressure and worked to the edges, avoiding excessive tension of the skin. If longer strips of tape are to be applied, the lining paper should be removed progressively.

Children: Courses should be limited to five days and tight coverings should not be used. If irritation or infection develops, remove tape and consult a physician. Contra-indications: Chicken pox; vaccinia; tuberculosis of the skin; hypersensitivity to any of the components; facial rosacea; acne vulgaris; perioral dermatitis; perianal and genital pruritus; dermatoses in infancy including eczema, dermatitic napkin eruption, bacterial (impetigo), viral (herpes simplex) and fungal (candida or dermatophyte) infections.

Special Warnings and Precautions for use: Not advocated for acute and weeping dermatoses. Local and systemic toxicity of medium and high potency topical corticosteroids is common, especially following long-term continuous use, continued use on large areas of damaged skin, flexures and with polythene occlusion. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitaryadrenal (HPA) axis suppression. Long-term continuous therapy should be avoided in all patients irrespective of age. Application under occlusion should be restricted to dermatoses in very limited areas. If used on the face, courses should be limited to five days and occlusion should not be used. In the presence of skin

infections, the use of an appropriate antifungal or antibacterial agent should be instituted. For children, administration of topical corticosteroids should be limited to the least amount compatible with an effective therapeutic regimen. Children may absorb proportionally larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity. Pregnancy and Lactation: Use in pregnancy only when there is no safer alternative and when the disease itself carriers risks for mother and child. Caution should be exercised when topical corticosteroids are administered to nursing mothers. Undesirable Effects: The following local adverse reactions may occur with the use of occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acne form eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, miliaria, striae and thinning and dilatations of superficial blood vessels producing telangiectasia. Transient HPA axis suppression. Cushing’s syndrome. Hyperglycaemia. Glycosuria. Adrenal suppression in children may occur. Local hypersensitivity reactions. Stop treatment immediately if hypersensitivity occurs. Precautions for Storage: Store in a dry place, below 25°C. Pack size and price: Polypropylene dispenser and silica gel desiccant sachet in a polypropylene container, with a polyethylene lid, packed in a cardboard box, containing 20cm or 50cm of translucent, polythene adhesive film, 7.5cm wide, protected by a removable paper liner. 7.5cm x 20cm £12.49. 7.5cm x 50cm £18.75. Legal Category: POM Marketing Authorisation Number: PL 00551/0014 Marketing Authorisation Holder: Typharm Ltd. 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH. Tel: 01603 722480, Fax: 01603 263804. Date of Revision of Text: February 2021.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

Adverse events should also be reported to Typharm Limited on 02037 694160.

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BDNG NEWS

Sponsors of

Ann Davies, BDNG President 2012-13, retires Bev Gambles

A

fter 46 years of nursing in dermatology, Ann Davies has decided to retire.

many happy moments meeting other members at conferences when numbers of members were less than 50. She has witnessed the BDNG’s growth from a small group of enthusiastic dermatology nurses who share the same ideals, to a large organisation of a few thousand members with ties internationally.

This is a very sad time for all of us who have worked closely with Ann and we wish her a well-deserved, happy, and healthy retirement. Ann is well known throughout dermatology nursing and has been an inspiration to many junior nurses who wished to pursue a career in dermatology.

Ann’s commitment to dermatology and the care of her patients has ensured that she has a valuable relationship with them, enhancing their treatment significantly. The dermatology nursing community will miss Ann greatly.

Ann’s reputation as a dedicated professional spread far and wide Ann joined South Glamorgan Health Authority in 1974 as a student nurse, and upon qualifying commenced her dermatology career. Ann quickly became ward sister and then Clinical Nurse Specialist in the dermatology clinic. Throughout, Ann has been passionate about delivering high-quality care and is a committed dermatology nurse. Her pride in her speciality has ensured that she has remained at the forefront of dermatology nursing.

Ann’s reputation as a dedicated professional spread far and wide. For many years, her involvement in delivering nurse education diploma and degree

www.bdng.org.uk

level distance learning courses with Cardiff University and Aneurin Bevan Heath Board took her across the country to mentor and support students.

A particularly proud moment was when Ann became President of the British Dermatology Nursing Group in 2012. During this time Ann was responsible for overseeing the transition of the BDNG from a charity affiliated to the British Association of Dermatologists to fully independent status.

Ann was one of the founding members of the BDNG and recalls

From all of us Ann: enjoy your welldeserved retirement. Plenty of time now for you to relax and enjoy your hobbies of cooking, travel, and WI! DN

BDNG Annual

Conference The BDNG is delighted to be holding our postponed 30th Annual Conference on 21 – 23 September 2021 at the Harrogate Convention Centre.

Dermatological Nursing, 2021, Vol 20, No 2

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*Max daily dose 6 plasters, Max treatment period 30 days

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BDNG NEWS

Sponsors of

Introducing the BDNG App We are delighted to introduce the BDNG App. This will give members year-round access to membership benefits conveniently on your phone or tablet.

Step 1

Step 4

Step 6

Download the Engagefully App for the App Store or Play Store.

Allow notifications. We promise that we won’t bombard you with endless notifications and you can disable this at any time. You can change your preferences by clicking on your account and selecting the ‘Manage’ button in the organisational preferences section.

Setting up your account:

Step 2 Enter BDNG into the search bar and tap on our name to select.

1. Click on the account icon and enter your emails address (that you can access from your phone/tablet).

You will receive an email to activate your account.

2. BDNG website login. Login into you BDNG account in the normal way.

Don’t worry there are links to reset your password or contact us directly if you have forgotten your details.

That’s you all set up to access the member’s only content through the BDNG App as well as any events that you have registered for.

Step 3 Customise the App by switching it to the BDNG logo. This will change the icon on your phone/tablet.

www.bdng.org.uk

We hope you enjoy using the BDNG App. If you have any comments or questions about it or would like to suggest other content to add to it, please contact us at admin@bdng.org.uk. DN

Step 5 Click on the menu button to get started.

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BDNG NEWS

Sponsored by

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Looking to the future Julia Wheeler

A

s lockdown three slowly comes to an end, the BDNG are now starting to look forward to face-to-face events, with our postponed Skin Surgery and Phototherapy courses scheduled to take place on 24th June in Birmingham. Whilst these courses are fully subscribed, we very much hope to repeat them soon. Please register your interest if you would like to attend at the next available opportunity.

Conference planning is also well underway, with registration now open for the event which is taking place on 21st-23rd September at Harrogate Convention Centre. This will be our 30th Annual Conference, and as well as it being a great learning opportunity for delegates, we very much want it to be a celebration marking the significant progress made within the dermatology nursing profession during this time.

Dermatology nursing has evolved to encompass broader scopes of clinical practice and increased professional opportunities. These changes correlate with increasing expectations of patient care and improvements in their quality of life. It is remarkable to consider how much of this progress can be attributed to the direction and support offered by the BDNG to its members.

In my clinical role, the last few months have been more busy than usual as I have strived to balance my own professional development with the expectations of my day jobs. I have been studying Advanced History Taking and Assessment Skills at Oxford Brookes University, which was identified as a requirement by my employer before 66

embarking on the prescribing course.

I thought I was done with study, but over the last few months I have had to purchase a stethoscope, learn to recognise heart sounds, palpate livers and spleens, and revise the muscular skeletal system like never before.... I’m exhausted!

It was a demanding course culminating with an OSCE assessment which involved much mumbling and dithering as I struggled to diagnose my mock patient’s cardiac concerns. Still, it’s always good to learn new things and it has inspired me to look at how we, as dermatology nurses, approach the assessment of skin disease. It has challenged me to think more about the wider implications of the patient’s health before jumping to conclusions based solely on the visual appearance of the lesion or rash.

I have been working on developing some new case studies for our e-learning platform With this in mind, I have been working on developing some new case studies for our e-learning platform. I hope you will look at these new resources and let me know your thoughts on ways they could be improved. I hope they will be supportive in guiding you with the process of assessment as well as introducing you to the features of some specific skin conditions.

Since the start of the pandemic, many of us have spent longer periods of time in front of a computer screen.

Many members have opted to receive a digital copy of the journal and this can be beneficial for many reasons, not least of all from an environmental perspective.

Dermatological Nursing, 2021, Vol 20, No 2

However, it is sometimes refreshing to move away from a screen and for this reason, the BDNG has decided to embark on the use of podcasts to offer accessible and alternative approaches to professional development. The series of podcasts – which will be released in June – aim to highlight new initiatives and promote interest and debate in a range of subjects relevant to the dermatology nursing profession. There will be calls to participate and contribute in some of these recordings and we hope that many of you will seize the opportunity to share your views, perspectives, and specialist knowledge if the opportunity arises.

One of the key attributes for advancing practice in Dermatology Nursing is a strong understanding and engagement with research. This was clearly highlighted in the recently published Role Descriptors document (BDNG 2020) which outlines the potential scope of clinical research throughout the stages of career progression. For many nurses, the retrieval of research and the vocabulary used in scientific papers can be a significant barrier to their development in this area. For this reason, we are collaborating with the UK DCTN to establish a research nursing group which we envisage will encourage members to gain the confidence to participate in research projects and eventually support them to lead future clinical trials. Webinar meetings led by the group are scheduled to take place from mid-June. Research opens the huge potential for promoting patient care and future improvements in dermatology services. I very much hope that you will consider joining the group to learn more about the opportunities available in this exciting branch of dermatology nursing.

Keep your eyes out for email alerts or contact education@bdng.org.uk for more information. DN www.bdng.org.uk

The British Dermatological Nursing Group Corporate Sponsors

The BDNG would like to thank all our corporate sponsors for their support and continued investment with the BDNG

IN THESE UNPRECEDENTED TIMES, YOU HAVE A CHALLENGING ROLE.

Do you have a backlog of patients and increased waiting times?

Are you having to manage patients’ fears during a pandemic?

Prescribing SKYRIZI®

Have you had to redesign your service?

Do virtual consultations carry technical challenges?

Is there increased pressure to get it right first time?

(risankizumab) for moderate to severe plaque psoriasis* offers:

Durability

Simplicity

Safety profile

85% of patients achieved PASI 90 through to 3.3 years †1

Every 12 week maintenance dosing after initial starter dosing 2

Consistent safety profile through to 4 years **1

* SKYRIZI® (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.2

† Data from LIMMitless; an ongoing phase 3, single-arm, multicentre, international, open-label extension in which all patients receive SKYRIZI (150 mg) every 12 weeks.

The 172 week analysis included patients who were initially randomized to receive SKYRIZI (150 mg) in 1 of 5 base phase II/III studies. Results from 172 week interim analysis including integrated data from five phase 2/3 studies (UltIMMA-1, UltIMMa-2, SustaIMM, IMMvent, and NCT03255382)2-5 and the LIMMitless study. Efficacy was assessed every 12 weeks by PASI 90, PASI 100, sPGA 0/1, mean PASI percent improvement. Quality of life was assessed every 24 weeks by DLQI 0/1. LOCF (last observation carried forward): used completed evaluation from the most recent visit to impute missing data at later visits. PASI 90 = 90% improvement in Psoriasis Area and Severity Index. ** Long term safety included patients in LIMMitless who were initially randomized to receive SKYRIZI (150 mg) in 1 of 5 base Phase II/III studies (patients with continuous SKYRIZI use). The 208 week interim analysis includes integrated data from the five Phase 2/3 studies (UltIMMA-1, UltIMMa-2, SustaIMM, IMMvent, and NCT03255382) and the LIMMitless study.

PRESCRIBING INFORMATION (PI) SKYRIZI™(risankizumab) 75 mg solution for injection in pre-filled syringe Refer to Summary of Product Characteristics (SmPC) for full information before prescribing.

PRESENTATION: Each pre-filled syringe contains 75 mg risankizumab in 0.83 ml solution.

INDICATION: For treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

DOSAGE AND ADMINISTRATION: Intended for use under guidance and supervision of a physician experienced in diagnosis and treatment of psoriasis. Dosage: The recommended dose of Skyrizi is 150 mg (two 75 mg injections) by subcutaneous injection at weeks 0, 4, and every 12 weeks thereafter.

Consider discontinuation of treatment in patients showing no response after 16 weeks of treatment.

Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. Special Populations: Elderly: No dose adjustment required. Renal or hepatic impairment: No dose adjustment required. Paediatric Population: No data available.

CONTRAINDICATIONS: Hypersensitivity to any of the active substances or excipients. Clinically important active infections.

SPECIAL WARNINGS AND PRECAUTIONS: See SmPC for full details. Skyrizi may increase the risk of infections. In patients with a chronic infection or history of recurrent infections, or known risk factors for infection, Skyrizi should be used with caution. Treatment with Skyrizi should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients should be evaluated for tuberculosis infection prior to initiating treatment. Anti-TB therapy should be considered prior to initiating Skyrizi in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Completion of all appropriate

immunisations should be considered prior to initiating therapy. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with Skyrizi.

Patients treated with Skyrizi should not receive live vaccines during treatment and for at least 21 weeks after treatment. Skyrizi contains 68.0 mg sorbitol and less than 1 mmol sodium (23 mg) per 150 mg dose.

INTERACTIONS: The safety and efficacy of Skyrizi in combination with immunosuppressants, including biologics or phototherapy have not been evaluated.

PREGNANCY AND LACTATION: Women of Childbearing potential: An effective method of contraception during treatment and for at least 21 weeks after treatment should be used. Pregnancy: Limited data available. It is preferable to avoid the use of Skyrizi during pregnancy as a precautionary measure. Lactation: It is not known whether Skyrizi is excreted in breast milk. Skyrizi may be used during breast-feeding if clinically needed. Fertility: The effect of Skyrizi on human fertility has not been evaluated.

ADVERSE REACTIONS: See SmPC for full details on adverse reactions. Very common adverse reactions (≥1/10): Upper respiratory infections. Common adverse reactions (≥1/100 to <1/10): Tinea infections, headache, pruritus, fatigue and injection site reactions.

LEGAL CLASSIFICATION: POM MARKETING AUTHORISATION NUMBERS/PRESENTATIONS/NHS LIST PRICE: EU/1/19/1361/001: Skyrizi 75 mg solution for injection in pre-filled syringe (Pack of 2 pre-filled syringes): £3326.09 LOCAL REPRESENTATIVE: AbbVie Ltd, Maidenhead, SL6 4UB DATE OF REVISION: April 2019 PI-Skyrizi-001

Adverse events should be reported. Reporting forms and information can be found at: https://yellowcard.mhra.gov.uk.

Adverse events should also be reported to AbbVie on GBPV@abbvie.com

References: 1. Papp K, et al. Poster 1366, presented at European Academy of Dermatology and Venereology (EADV) Congress, October 2020. 2. SKYRIZI Summary of Product Characteristics.

UK-RISN-210041 Date of preparation: February 2021