Aesthetics September 2017

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VOLUME 4/ISSUE 10 - SEPTEMBER 2017

PR OU D S PON S OR OF T H E A ES T H ET I C S AWA R D S 2 0 1 7

F I N A L I S T

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Menopause and the Skin CPD Practitioners discuss the literature on the menopause’s effect on skin

I N J EC TA B L E PR OD U C T OF THE Y E A R

Special Feature: Managing Infections Practitioners provide an overview on managing dermal filler infections

Taking a Medical History Jenny O’Neill shares advice on collating a patient’s medical history prior to treatment

Aesthetics Awards: Finalists Announced Finalists are revealed for the Aesthetics Awards 2017

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Contents • September 2017 06 News

The latest product and industry news

14 News Special: Should Dermal Filler be a POM?

Aesthetics investigates how making filler a POM could impact the specialty

CLINICAL PRACTICE 21 Special Feature: Infection Control

Practitioners discuss the risks of infection from dermal fillers and provide tips on prevention and management

29 CPD: Cutaneous Ageing and the Menopause

Special Feature Infection Control Page 21

Dr Michael Barnish and Miss Jonquille Chantrey review literature on the menopause and the effects it can have on the skin

34 Spotlight On: Clinisept+

Aesthetics learns more about a new skin disinfectant

37 Aesthetics Awards: Finalists Announced

The finalists for the Aesthetics Awards 2017 are revealed

42 Case Study: Managing Infection

Dr Michael Aicken details how he successfully treated a patient’s hyaluronic acid infection

46 Sodium Dismutase

Dr Charlene DeHaven provides an overview of the uses of antioxidant superoxide dismutase

49 Stem Cells

Dr Jenna Burton examines the role of topical stem cells in aesthetic medicine and evidence for their use

53 PDO Thread Outcomes

Dr Irfan Mian details what practitioners should be aware of when using PDO cog threads

56 Advertorial: Med-fx

Find out more about the service delivered by Med-fx

58 Advertorial: VANIQA

Treating unwanted facial hair: optimising outcomes in ‘problem patients’

59 Abstracts

A round-up and summary of useful clinical papers

IN PRACTICE 60 Mitigating Risks to Mitigate Costs

Medical malpractice and risk specialist Martin Swann advises on mitigating insurance risks within a clinic

63 Taking a Medical History

Nurse prescriber Jenny O’Neill discusses what to consider when taking a patient’s medical history

67 Consulting Transgender Patients

Dr Helen Webberley details important considerations to make when consulting transgender patients

70 In Profile: The Kings

Dr Martyn King and nurse prescriber Sharon King reflect on their careers and achievements in aesthetics

72 The Last Word

Dr Ifeoma Ejikeme considers how beauty video bloggers can impact patient requests

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In Practice Patient Medical History Page 63

Clinical Contributors Dr Michael Barnish is a graduate of Lancaster University and the associate doctor at Expert Aesthetics by Dr Jonquille Chantrey in Cheshire. He specialises in aesthetic treatments with a focus on skin rejuvenation.

Miss Jonquille Chantrey has more than 14 years’ experience in aesthetics and surgery. An international key opinion leader, she has lectured throughout Europe, Russia, Australia, the US and Asia. She is also a principal investigator in multiple clinical trials.

Dr Michael Aicken graduated in 2006 from the University of Aberdeen with a degree in medicine and a Bachelor of Medical Sciences. Dr Aicken established Visage Academy and has also been involved in the development of an aesthetic clinic management app.

Dr Charlene DeHaven is a board-certified physician in both internal medicine and emergency medicine with an emphasis on age management and health maintenance. She currently lectures at the University of Washington.

Dr Jenna Burton is an aesthetic practitioner who is heavily involved in population health promotion. She has obtained a diploma from the American Academy of Aesthetic Medicine and is currently working towards her American Medical Board Specialist Status.

Dr Irfan Mian is medical director of the Chinbrook Medical Cosmetic Centre in London and has practised medicine for more than 30 years. He is a threadlift and aesthetic medicine trainer and has been a clinical lecturer at King’s College and Guy’s Hospital NHS Trust.

Vote now for the Aesthetics Awards 2017 www.aestheticsawards.com

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Editor’s letter At last, the time has arrived to reveal the finalists for the Aesthetics Awards! Flick to p.37 to find out if you’re a finalist now! As ever, the standard of entries was exceptionally high, making it extremely difficult to create a shortlist.

Amanda Cameron You can book your tickets for the ceremony on Editor December 2 via www.aestheticsawards.com.

This month we are focusing on managing infections in aesthetics; how to recognise them, how to treat them and, most importantly, how to prevent them. We have some great education in all of our articles, comprising the very best business and clinical knowledge.

Hopefully you will never need it but, just in case, we have a great piece on mitigating insurance risks within a clinic on p.60 by insurance consultant Martin Swann, as well as advice on how to take a good medical history by aesthetic nurse prescriber Jenny O’Neill on p.63, which may, in some way, help to avoid complications.

Our September Special Feature on p.21 focuses on infection – what

would you do if a patient presented with this concern, which can often occur months after treatment? Hear from experienced practitioners on how to manage infections following dermal filler injection, as well as their key tips on infection control protocols before and after treatment.

If that isn’t enough to get you thinking about preventing adverse events, check out Dr Michael Aiken’s case study (p.42) focused on when he was tasked with managing a filler complication.

Our In Profile is a double act this month – nurse prescriber Sharon King and Dr Martyn King share their career highlights in medical aesthetics. As you may know, Dr King was instrumental in establishing the Aesthetics Complications Expert (ACE) Group, to be able to offer necessary help and advice in a consistent manner to those that may be in need. Find out more about their work on p.70.

This September issue provides a wealth of information that you cannot afford to miss, so make sure you set some time aside for a good read this month!

Editorial advisory board

We are honoured that a number of leading figures from the medical aesthetic community have joined the Aesthetics journal’s editorial advisory board to help steer the direction of our educational, clinical and business content Mr Dalvi Humzah is a consultant plastic, reconstructive and aesthetic surgeon with over 20 years’ experience. He is an international presenter, as well as the medical director and lead tutor of Medicos Rx. Mr Humzah also runs the multi-award winning Dalvi Humzah Aesthetic Training courses. He is a founding member of the Academy of Clinical Educators at the Royal College of Physicians and Surgeons of Glasgow.

Dr Raj Acquilla is a cosmetic dermatologist with more than 12 years experience in facial aesthetic medicine. In 2015 he won the Aesthetics Award for Aesthetic Medical Practitioner of the Year and in 2012 he was named Speaker of the Year. Dr Acquilla is a UK ambassador, global KOL and masterclass trainer in the cosmetic use of botulinum toxin and dermal fillers.

Sharon Bennett is chair of the British Association of Cosmetic Nurses (BACN) and the UK lead on the BSI committee for aesthetic non-surgical medical standards. She is a registered university mentor in cosmetic medicine and currently a second year student on the Northumbria University Masters course in non-surgical cosmetic interventions.

Bennett has been developing her practice in aesthetics for 25 years.

Dr Tapan Patel is the founder and medical director of PHI Clinic. He has more than 17 years’ clinical experience and has been performing aesthetic treatments for more than 14 years. Recently, he was listed in Tatler’s Top 30 Anti-Ageing Experts. Dr Patel is passionate about standards in aesthetic medicine and ensures that along with day-to-day clinic work he also attends and speaks at numerous conferences.

Mr Adrian Richards is a plastic and cosmetic surgeon with 12 years of specialism in plastic surgery at both NHS and private clinics. He is a member of the British Association of Plastic and Reconstructive Surgeons (BAPRAS) and the British Association of Aesthetic Plastic Surgeons (BAAPS). He has won numerous awards and has written a best-selling textbook.

Dr Maria Gonzalez has worked in the field of dermatology for the past 22 years, dividing her time between academic work at Cardiff University and clinical work at the University Hospital of Wales. Dr Gonzalez’s areas of special interest include acne, dermatologic and laser surgery, pigmentary disorders and the treatment of skin cancers.

Dr Sarah Tonks is a cosmetic doctor, holding dual qualifications in medicine and dentistry. Based in Knightsbridge, London she practices a variety of aesthetic treatments. Dr Tonks has appeared on several television programmes and regularly speaks at industry conferences on the subject of aesthetic medicine and skin health.

Dr Stefanie Williams is a dermatologist with special interest in aesthetic medicine. She is the founder and medical director of the multiaward winning EUDELO Dermatology & Skin Wellbeing in London. She lectures in the Division of Cosmetic Science and has published more than 100 scientific articles, book chapters and abstracts. Dr Williams is also author of Amazon-No-1 Bestseller ‘Future Proof Your Skin’.

Dr Christopher Rowland Payne is a consultant dermatologist and internationally recognised expert in cosmetic dermatology. As well as being a co-founder of the European Society for Cosmetic and Aesthetic Dermatology (ESCAD), he was also the founding editor of the Journal of Cosmetic Dermatology and has authored numerous scientific papers and studies.

Dr Souphiyeh Samizadeh is a dental surgeon with a Master’s degree in Aesthetic Medicine and a PGCert in Clinical Education. She is the clinical director of Revivify London, an honorary clinical teacher at King’s College London and a visiting associate professor at Shanghai Jiao Tong University. Dr Samizadeh frequently presents at international conferences and is passionate about raising industry standards.

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Awards

Talk #Aesthetics

Finalists announced for the Aesthetics Awards 2017

Follow us on Twitter @aestheticsgroup #Henna Dr Anjali Mahto @DrAnjaliMahto Chatting about black henna and its risks this lunchtime for @BSFcharity #dermatology #medicine #EditorialBoard Souphiyeh Samizadeh @drssamizadeh @aestheticsgroup it is a pleasure to be invited to join the Aesthetics editorial board. Looking forward to it. #Aestheticsjournal #Recognition Barbara Jemec @bjemec So honoured to be featured in the WMF centenary publication #equality #women #medicine #ILookLikeAPlasticSurgeon #surgery #honoured

#Training Dr Bawa Aesthetics @drbawaaesthetic Looking forward to learning advanced techniques with @ApulParikh @MATACourses tomorrow…can’t wait! #excited #alwayslearning

After two months of deliberation and careful consideration, the finalists for the Aesthetics Awards 2017 have at last been revealed. A record number of entries were received with a higher standard than ever before. Finalists, which are listed on pages 37-41, will have the chance to be recognised as Commended, Highly Commended or Winners in their respective categories.

The Winners will be presented with trophies on the evening of December 2, at the Park Plaza Westminster Bridge Hotel in London.

The celebratory event will include a networking reception, a threecourse dinner, entertainment from a top comedian, the Awards presentation and music and dancing late into the night. Guests will once again be able to enjoy use of the photo booth, with Church Pharmacy sponsoring it for a second year, which provides guests with the use of props and instantly-printed photographs.

Director of Church Pharmacy, Zain Bhojani, said, “The team at Church Pharmacy are proud to sponsor the Aesthetics Awards once again. For us, it’s a great opportunity to catch up and celebrate with friends. Also, the photo booth was such a hit last year so hopefully guests can enjoy it again and take home some special memories of the best Awards ceremony in the aesthetics specialty.”

To see the full list of finalists, see pages 37-41 of this month’s journal.

To book tickets and to vote, visit www.aestheticsawards.com.

Level 7

#FacialAnatomy LondonMedEdAcademy @LMEDAC Another @BACNurses #facialanatomy course is underway #Clinic S-Thetics @MissBalaratnam Enjoying my Saturday clinic back in #Beaconsfield today #skintreatments #aesthetics #skinanalysis #HydraFacial #ICONlaser #skinwellness #Congress Dr Stephen Lowe @DrStephenLowe Heading back to Sydney after a great few days of learning, amazing food and making new friends. Thanks @MerzAesthetics and @imcascongress

Harley Academy offers Level 7 Fast Track Aesthetic training provider Harley Academy has developed a new Level 7 programme aimed at experienced practitioners, with busy schedules, who are looking to obtain the qualification.

The Level 7 Fast Track in Injectables has been created so that busy practitioners can fit studying around clinical and personal commitments. The programme, which is open to practitioners with three years’ experience or more or those who have delivered a minimum of 100 botulinum toxin/dermal filler treatments (50 for each), can be completed purely through the assessment component.

In order to complete the course, a logbook must be submitted which will detail either; samples of treatment cases delivered over the past three years or more, evidencing at least ten treatments per modality or year, or alternatively; samples of treatment cases delivered within the past three years, evidencing at least 100 treatments in total; 50 per treatment modality. Alongside the logbook submission, practitioners must successfully undertake assessments of practical skills and knowledge prior to certification.

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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Events diary 15th - 16th September 2017 British Association of Cosmetic Nurses Autumn Aesthetic Conference, Birmingham www.bacn.org.uk

23rd September 2017 British College of Aesthetic Medicine Conference, London www.bcam.ac.uk

2nd December 2017 The Aesthetics Awards 2017, London www.aestheticsawards.com

27th - 28th April 2018 The Aesthetics Conference and Exhibition (ACE) 2018, London www.aestheticsconference.com

Veins

ThermaVein introduces new technology

Aesthetics

Training

Dalvi Humzah Aesthetic Training announces Level 7 course dates The first Level 7 Advanced Professional Award in Applied Clinical Facial Anatomy for Cosmetic Interventions course dates have been announced for September and November. King’s College London will host the course, run

by Dalvi Humzah Aesthetic Training and the Medical Aesthetic Training Academy (MATA), on September 11 and 12. Delegates in the north of England and Scotland can attend the Level 7 course at The University of Glasgow’s Clinical Anatomy Skills Centre on November 24 and 25. The course is a recognised postgraduate qualification that is delivered through MATA and awarded by EduQual, which is also endorsed by Training Qualifications UK, an Ofqual-recognised awarding organisation. According to the training providers, the qualification comprises two compulsory units; Anatomical Basis for Cosmetic Interventions, and Preventing and Treating Complications through Advanced Facial Anatomy. It will use wet-tissue specimens for anatomical teaching, together with written assessments, objective structured clinical examination stations and reflective portfolios, in order to gain the Level 7 postgraduate qualification. As part of the qualification, delegates will also complete online knowledge modules, faceto-face teaching and assessments. Consultant plastic, reconstructive and aesthetic surgeon and lead tutor, Mr Dalvi Humzah, said, “We are absolutely thrilled to be able to offer the Level 7 Advanced Professional Award in Applied Clinical Facial Anatomy for Cosmetic Interventions at two prestigious sites – King’s College London and the University of Glasgow in September and November, respectively. This will allow our colleagues to access this unique qualification north and south of the UK.” Standard

Energy device ThermaVein has released the technology upgrade ThermaVein Rapide (TVR) to treat large veins. The TVR is now available in the UK and Europe and aims to deliver a controlled, rapidly repeating pulse to improve the efficacy of treatment for veins whilst improving patient comfort.

The new technology is said to deliver powerful safe pulse bursts between 0.5 to three seconds apart, which, in turn, aims to result in better thermal coagulation, where recanalisation of the vessel is less likely after treatment. The launch coincides with the British company’s fifth birthday and its distribution expansion into five continents. John Fisher, managing director of ThermaVein, said, “We have been working on this system for some time and we are delighted to launch it in the UK for our fifth birthday celebration.

The results are amazing and we cannot wait to show the new device off – we are so confident of the results and it’s a pleasure to take it out and show practitioners in their own clinics.”

ThermaVein is CE certified and FDA registered.

New European Standard on non-surgical aesthetics A new European Standard on non-surgical aesthetics has been published by the British Standards Institution (BSI). The Standard, titled Aesthetic medicine services – Non‑surgical medical treatments EN 16844, was published on July 31 and is available now. It is designed to bring an improvement to aesthetic medicine services, to enhance patient safety and reduce the risk of complications, promote consistently high standards for aesthetic medicine service providers across Europe, and increase patient satisfaction. The Standard covers a vast range of treatments, including chemical peels, botulinum toxin injections, dermal fillers, microneedling, laser and IPL, ultrasound and cryolipolysis. Other topics covered are: competencies, management and communication with patients, facilities, treatments, and code of ethics for marketing and advertising. According to the BSI, the government often draws on standards when putting together legislation or guidance documents. Aesthetic nurse prescriber and chair of the British Association of Cosmetic Nurses (BACN), Sharon Bennett said, “This European Standard represents years of hard work from a wide variety of medical specialists and consumer representatives in non-surgical aesthetic procedures. For both doctors and nurses in the UK, it gives us a sensible benchmark in good practice and may ultimately be used more widely to support other work being carried out nationally. She continued, “Having been part of the committee myself, it has been a challenging journey to enable nurses onto the standard but we are firmly on it.”

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

@aestheticsgroup Hyperhidrosis

miraDry+ launches in the UK Global medical device company Miramar Labs has launched an upgraded version of its miraDry device for treating underarm sweat and odour.

The new miraDry+ is an energy device that uses precisely controlled electromagnetic energy to create a suction action, delivering energy to the skin and glands. The energy heats the glands and aims to permanently eliminate them, while a cooling fluid flows through the device to protect the epidermis from excess heating. According to Miramar Labs, the original device provides long-lasting and permanent results after two treatments, whereas the miraDry+ does this in only one, due to a stronger level of energy. Miramar Labs also claims that the miraDry+ treatment only takes 40 minutes and can be used on all skin types.

Conference

New sponsors announced for ACE 2018 New sponsors have been announced for the Aesthetics Conference and Exhibition (ACE) 2018. Sponsors of sessions within the Expert Clinic agenda will include UK distributor HADerma, laser developer and manufacturer Cynosure, and French medical device company Needle Concept. In addition, aesthetic equipment supplier Cosmetronic has been confirmed as ACE 2018’s Equipment Partner.

Sales and marketing manager of HA-Derma, Iveta Vinklerova, said, “We are delighted to be sponsoring ACE 2018. The conference and exhibition was a huge success last year and we are pleased to be a part of it again. We are looking forward to highly educational content and interesting topics from experts.” She added, “2018 will be a great year for us with some amazing product launches and we will continue to deliver new emerging concepts in antiageing medicine with PROFHILO.” Featuring at ACE will be presentations from clinical and business experts to provide guidance for practitioners, enabling them to further their professional development. Delegates will also be able to discover the latest aesthetic products on the 2,500m2 Exhibition Floor. ACE 2018 will take place on April 27 and 28 and free registration will open in October. To stay updated with the latest news and developments, become a member of the www.aestheticsconference.com.

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Vital Statistics In a survey of 288 dermatologists in the UK, 72% believe reactions to henna tattoos are increasing every year (Skin Health Alliance, 2017)

Out of 41 aesthetic clinics surveyed in the UK, 73% reported an increase in demand for lip filler this year (WhatClinic.com, 2017)

Among 330 current users of sunbeds in Germany, 19.7% screened positive for symptoms of an indoor tanning addiction (British Association of Dermatologists, 2017)

Market research company Forrester reported that including video in an email leads to a 200-300% increase in click-through rate (Forrester, 2016)

According to 2,000 patient records in the UK, on average, women are now opting for cosmetic surgery by the age of 39 – down from the age of 42 in 2012 (Dr Julian De Silva, Centre for Advanced Facial Cosmetic and Plastic Surgery, 2017)

There were 18,489 reported buttock augmentations with fat grafting procedures in the US in 2016, up from 14,705 in 2015 (American Society of Plastic Surgeons, 2017)

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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Level 4

AAA confirms Level 4 courses Aesthetic training provider Academy of Advanced Aesthetics (AAA) has launched 11 new Level 4 courses. The courses will cover topics on high intensity focused ultrasound (HIFU) for the face and neck, cryotherapy-induced lipolysis, ultrasonic lipo-cavitation and radiofrequency. The AAA aims to provide quality medical education for aesthetic practitioners, focusing on a combination of technique, safety, patient care and correct machine operation during training events. Principle of the AAA, Barbara Freytag, said, “I am delighted to announce the launch of our new Level 4 courses. I’m pleased that we are able to offer a huge range of training options that delegates can choose from.” The training will be taking place in Cambridgeshire and dates will be announced shortly.

Skincare

iS Clinical releases new facial treatment Cosmeceutical skincare brand iS Clinical has launched its new treatment, Elements Fusion. The treatment combines iS Clinical’s Fire & Ice peel and the HydraFacial MD facial. According to the company, iS Clinical Fire & Ice is a clinical treatment that combines glycolic acid with retinol, that aims to resurface and treat problematic skin, reduce fine lines and encourage cellular renewal. The cosmeceutical facial peel comprises two treatment masques combined with selected iS Clinical products, aiming to resurface the skin to produce a tighter, brighter and more luminous complexion.

Elements Fusion integrates this with the HydraFacial MD, which, according to the company, provides a youthful glow by removing surface damage, replenishing skin with antioxidants and stimulating collagen production by delivering red LED light. iS clinical states that the hour-long Elements Fusion treatment can be used quarterly to boost existing monthly Fire & Ice and HydraFacial treatments. Alternatively, the company says it can be used as a luxury standalone treatment, aiming to offer the existing benefits of both the Fire & Ice and HydraFacial treatments.

Training

DSL Consulting and Cliniva Cosmetic Training to hold business event Cliniva Cosmetic Training and DSL Consulting have announced details of their new training event, the Aesthetic Business Training Day. The event will cover important business topics for aesthetic clinics, including branding, website development, self-promotion, marketing and sales. The aim of the training will be to help new and existing practitioners who own, or are looking to start their own businesses, providing advice on how to run a successful clinic.

A number of professionals will speak at the event, including insurance and claims manager of Hamilton Fraser, Naomi Di-Scala, managing director of DSL Consulting, Danny Large, and nurse prescriber and trainer Jacqueline Naeini, of Cliniva Cosmetic Training.

Large said, “I’m delighted to be partnering with Cliniva Cosmetic Training on this exciting project. By ensuring group numbers are small, we feel that delegates will get more interaction, not only with speakers but with each other, and having such a fantastic training provider as Cliniva Cosmetic Training will only enhance the day.”

The training will take place on November 11 at Cliniva Cosmetic Training in Barnsley.

BACN UPDATES A roundup of the latest news and events from the British Association of Cosmetic Nurses

BACN PRE-CONFERENCE WORKSHOP DAY: SEPTEMBER 15 There has been a brilliant response from BACN members booking on to the pre-conference workshops the day before the Autumn Aesthetic Conference. We look forward to welcoming a range of different industry leaders to speak about key areas including anatomy, clinical demonstrations, and the changing nature of education and training in aesthetics. The day is then followed by our evening drinks reception sponsored

by Wigmore Medical in the exclusive SkyBar at the Park Regis in Birmingham. BACN members can go to www.bacn.org.uk/events for more information.

AUTUMN AESTHETIC CONFERENCE The BACN Autumn Aesthetic Conference is happening this month (Saturday September 16) at the International Convention Centre in Birmingham. It’s bigger and better than ever, with a whole range of exhibitors and speakers ensuring that the event will be suitable for all nurses working in aesthetics. BACN members can book on for free as part of their membership, and guests are also welcome. It’s something not to be missed!

BACN MEMBERSHIP The BACN is now reviewing its member services to reflect a large growth in membership (25 new members a month are joining). Growth is not only coming from new nurses entering aesthetics but from many experienced aesthetic practitioners looking for support, as regulation, education and training are changing rapidly. The BACN will be launching a number of new programmes in autumn 2017 to reflect the needs of all of its different members.

MEET A MEMBER Allison Roberts qualified as a nurse in Barnsley, South Yorkshire in 1981 and spent 36 years in various nursing roles, including leading an emergency and trauma team, main theatre nursing, and post-op recovery. She is a qualified independent nurse prescriber, as well as an EqIA assessor, sign-off mentor, and Sheffield University link nurse for Barnsley students.

Allison works with her partner, Don McCarron, at Roberts McCarron Skin Clinic, which has busy aesthetic practices in Barnsley and Huddersfield. She said, “I’m excited to be on the BACN board, liaising with members and helping to maintain professional standards.”

This column is written and supported by the BACN

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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Symposium

Vida Aesthetics to hold symposium UK distributor Vida Aesthetics will host a one-day symposium in September to showcase its extensive range of products.

The Vida Symposium will present mesotherapy and homecare products by TOSKANI Cosmetics, the Pistor Mesotherapy Eliance injection gun, dermal fillers, Vida Aesthetics’ range of medical gas machines which includes the new Automatic Patting System (APS), the new polynucleotide biorevitaliser gel Plenhyage and Jalucomplex hyaluronic acid. As well as this, the French depigmentation system UNIQ-WHITE will be launching at the symposium. Delegates will be separated into different sessions throughout the day according to their interests and available time. There will be four separate rooms, each dedicated to a product or procedure, with three presentations. Director of Vida Aesthetics, Eddy Emilio, said, “The Vida Symposium is a fantastic opportunity for practitioners to learn more about the latest products to arrive in the market, ask any questions and to meet colleagues and discuss the latest developments over a coffee. We are also truly delighted to be launching a new French depigmentation system, UNIQ-WHITE, in the UK at the symposium. We’ve seen the before and after pictures and we’re really excited about the positive impact this product could have on patients.” The symposium will be held at Premier Meetings near Heathrow Airport, on September 16. Registration is now open, with limited space available.

Skincare

ZENii London announces UK distributor

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Toby Cooper, Head of Aesthetics & Corrective, Galderma UK & Ireland How do you differentiate your products in such a competitive market?

Galderma is committed to dermatology with an enviable product portfolio, and a long heritage and history in aesthetics. Restylane has been trusted by practitioners for more than 20 years, delivering an established safety profile and high levels of patient satisfaction with over 30 million patient treatments.

You’ve recently launched a portfolio-based approach, why?

Every patient is different and therefore requires an individualised approach. Galderma has a versatile portfolio of products with the broadest range of gel textures to support natural looking results. We have designed a patient-based needs approach, simplifying practitioner choice; Refresh, Restore and Enhance. A key initiative this year is to improve our communication with patients. We’re launching a direct to consumer (patient) communication strategy to assist our customers in communicating the benefits of our high-quality portfolio. Restylane is a well-recognised brand and by integrating the Emervel products under the Restylane name, we can improve consistency across the portfolio to facilitate HCP and patient dialogue.

Going forward, what’s the primary focus for Galderma UK? We will continue to innovate and bring high quality products and services to the industry. We are working hard to ensure that our customer services and offerings are the envy of the industry and are concentrating on key areas:

London-based skincare and supplement company ZENii has signed with Consulting Room Group for UK distribution. ZENii is a new antiageing range that combines cosmeceutical skincare with nutrition and antiageing supplements, aiming to enhance cellular function and optimise cellular health from within. Included in the formulas are ingredients such as liposomal retinol, stem cells, peptides, hyaluronic acid, arbutin, glycolic acid, niacinamide, ferulic acid and salicylic acid. ZENii founder Dr Johanna Ward, who recently launched the range, said, “A skin cream alone is not enough. We have to look at and focus on all the other things that make cells healthy. We need an approach that combines clinically proven skincare with internal cellular micronutrition. This comprehensive approach is what I believe is the future of true antiageing.” Consulting Room director, Ron Myers, said of the distribution announcement, “We are delighted to be working with Dr Ward to launch ZENii. We believe ZENii offers something different and unique because it addresses the real issues that create cellular ageing and dysfunction, it reflects current trends that embrace wellness and nutrition. Very few clinics stock supplements currently, but we see this as a real gap in the market which offers huge potential.”

• Medical Education – The quality of the training will match the quality of our products. We will roll out a programme of supportive and innovative training and our plans will continue to bring improvements and innovation.

• Customer Support – We have some exciting developments to launch that will enhance the experience of our customers and their patients, focussing on natural and safe results.

• Quality & Leadership – We’ll cement our position as market leaders by ensuring high quality products and customer support.

RES17-08-0413

Date of Preparation: August 2017

This column is written and supported by

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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Skincare

Acne treatment launch Dermatological company SkinMed has announced the launch of its new acne treatment system, Acne TripleLock. The treatment system uses three of SkinMed’s products, including the TEBISKIN Cera-Boost, the TEBISKIN Reticap Face and the TEBISKIN OSK Lotion. According to the company, the TEBISKIN Cera-Boost utilises nine key ceramides and fatty acids which aim to build a dense lipid structure to boost the epidermis and control skin moisture levels. The retinol ingredient is then used through TEBISKIN’s Reticap product, which combines acetyl glucosamine and stabilised ascorbic acid to reduce hormonally induced skin thickening and excess keratin deposition. Acne TripleLock also uses the TEBISKIN OSK Lotion to target the visible manifestation of the infected spot. According to the company, the lotion reduces sebum production rates by an average of 53% and effectively targets Propionibacterium acnes, eradicating antibiotic resistant strains and calming inflammation.

Training

Medica Forte releases new training courses Aesthetic supplier Medica Forte has introduced new business and clinical training courses. The courses are in line with the new Health Education England guidelines and the company hopes the training will teach both new and experienced professionals in the aesthetic specialty how to run effective clinics. The CPD-certified courses will include Specialist Train The Trainer, Aesthetics Assertiveness Skills, Aesthetics Presentation Skills, Having A Powerful Impact, Controlling Your Time, Inspiring Your Team as well as clinical courses on Understanding Chemical Peels and Microsclerotherapy. The courses have been developed by CIPD qualified trainer, Jane Seward, who has 17 years’ experience in training and development. Nurse prescriber and clinical lead at Medica Forte, Kelly Saynor, said, “We’ve seen first-hand that there is a skills gap within the industry and talented professionals are simply crying out for advice on how to run their own clinic or practice – from delivering key note speeches at industry events, to being more self-assured in the workplace and getting more out of their teams.” She added, “There is currently nothing like this in the industry and we’ve had an absolutely overwhelming response from new and more established practitioners who are very talented in their field, but need to develop their core business competency skills.” The training will take place at Medica Forte’s training suite in Cheshire and courses will start this month.

Distribution

4T Medical becomes UK distributor for Cebelia Aesthetic product supplier 4T Medical has become the exclusive UK distributor for Cebelia, a skincare range new to the UK. According to the company, the Cebelia range is developed with innovative, patented active ingredients to improve recovery time and help prolong results following aesthetic procedures. Included in the range is the LCE Balm, which aims to accelerate the healing of superficial wounds, bruises and oedema.

Active ingredients within this product include patented laminine 5 active fragment, which aims to accelerate epidermal regeneration, blackcurrant berry extract for bruise reduction; and horse chestnut extract, which aims to reduce oedema. According to the company, the LCE Balm is ideally suited for pre- and post-aesthetic procedures such as dermal filler, PDO threads, blepharoplasty and rhinoplasty treatments. Also in the Cebelia range is the LCE Regard, a care cream that aims to correct dark circles; Reinforced Depigmenting, which is targeted towards correcting hyperpigmentation; and Soothing Milk (Body & Legs), which aims to ease drying, itching and erythema.

News in Brief Survey suggests majority of people think about weight daily Weight is of high concern to 52% of people who feel they are ‘fat’ and think about it every day, according to results from a recent survey by Syneron Candela and OnePoll.

However, despite this number, out of the 2,000 UK respondents, 97% also said they had not tried body contouring solutions, with 28% unaware that a treatment of this type existed. Dianne Burkhill, marketing manager at Syneron Candela, said, “Our survey results highlight that despite extensive media coverage, the general public are as yet largely unaware of the wider options available outside of diet and exercise.”

Valeant to sell Obagi Medical Valeant Pharmaceuticals International is to sell its Obagi Medical business for $190 million in cash, as part of its efforts to cut down its debt. The Canadian pharmaceutical company, which bought skincare brand Obagi Medical for $344 million in 2013, will sell the business to Haitong International Zhonghua Finance Acquisition Fund I,LP. Obagi skincare products will still be available in the UK and Ireland through Healthxchange Pharmacy, which has distributed the products since 2006.

Dermatologists see rise in henna tattoo reactions A survey of 288 dermatologists has suggested that 72% believe patient reactions to black henna temporary tattoos is increasing. Consultant dermatologist Dr Anjali Mahto has been campaigning with The British Skin Foundation to create patient and practitioner awareness on the risks associated with para-phenylenediamine, which is found within black henna tattoos.

Dr Mahto said, “Black henna is well-known to cause skin reactions and should be treated with caution, particularly in children. What might seem like pretty body art can quickly turn nasty with horrific blistering, permanent scars and, in the most severe cases, lifethreatening allergic reactions.”

BAD launches new website The British Association of Dermatologists (BAD) has developed a new website titled Skin Support for both practitioners and patients. The website, which was funded by a grant from the Department of Health’s Innovation Fund, is designed as a hub to provide a wealth of information on various skin conditions, including acne, eczema and rosacea, as well as self-help materials and support services.

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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Aesthetic Clinic Launches A look at the latest clinic openings across the UK

Electiva launches facilities for aesthetic practitioners Hospital group Electiva has launched a new national chain of independent hospitals that provide facilities for aesthetic practitioners. The launch of the new brand follows the acquisition of Transform Medical and The Hospital Group.

Electiva has three purpose-built Care Quality Commission registered facilities in South Manchester, Bromsgrove in Worcestershire and London. According to the company, all three facilities offer state of the art operating theatres, treatment rooms and consultation suites. Tony Veverka, CEO of Electiva, said, “I am really excited to be part of this innovative and exciting opportunity for the independent clinical sector. The launch of Electiva Hospitals will bring about many benefits to clinicians and, ultimately, patients who can be confident in the standards of care and quality of service.” Electiva is currently inviting surgeons and aesthetic practitioners to utilise its facilities.

The Clinic at Newton Place opens A new clinic that allows aesthetic practitioners in West Scotland to practise at a Health Improvement Scotland (HIS) regulated premises has opened.

According to owner and nurse prescriber Michelle Mclean, The Clinic at Newton Place was opened in response to new legislation in Scotland. Under the regulations, doctors, nurses and dentists cannot practise unless they are at a clinic that is registered with HIS and clinics are not allowed to operate without registering.

The space has a dedicated reception area, two waiting rooms and two spacious treatment rooms. All of the staff working on reception have an NHS background and have been fully trained in McLean’s own clinic, Age Refined.

“At a time of uncertainty with the impact of the new regulation in Scotland, I felt there was an opportunity to open The Clinic at Newton Place,” said McLean. She continued, “It’s a first of its kind that allows experienced practitioners to continue to inject and support new practitioners with a mentoring programme in a safe, HIS regulated, environment. In the long term, this protects the aesthetic industry in Scotland and allows it to grow.”

CAREFORSKIN AESTHETICS launches A new aesthetic clinic in Clitheroe, Lancashire, opened its doors to the public at the end of August.

CAREFORSKIN AESTHETICS is run by clinical director and medical aesthetic practitioner Dr Sobia Syed and business director Ali Shah. The clinic will offer a range of aesthetic treatments, including injectable procedures with PROFHILO, chemical peels, platelet-rich plasma, botulinum toxin, dermal fillers, mole and tag removal as well as laser hair removal.

“We have been operating a clinic out of Burnley for the last four years and have identified a demand for advanced aesthetics treatments within Clitheroe and the Ribble Valley area,” said Dr Syed, adding, “All treatments will be provided by myself, and I believe in delivering natural-looking subtle results. Safety and a duty of care is also an important aspect of our practice, ensuring that all patients are given realistic expectations of treatments.”

CAREFORSKIN AESTHETICS will be based in the Clitheroe Business Centre within Clitheroe Town Centre.

Dr Daniel Sister relocates clinic to Westminster Aesthetic practitioner Dr Daniel Sister has relocated from his Notting Hill location to join The Dentist Gallery clinic in Westminster. Dr Sister has been based in Notting Hill for the past 13 years and has decided that the move is the best option to further progress his aesthetics and hormone clinic.

Dr Sister said, “This move is very important to me as I have made the decision that my clinic should move in order to operate from within a medical environment. There is an obvious overlap between aesthetics and dentistry and The Dentist Gallery pushes the boundaries of a conventional dental practice to create an exceptional clinic and a highly dedicated team who share my work ethic and enthusiasm for safe, efficient, results-driven treatments.”

Co-owner of The Dentist Gallery, Dr Jerome Sebah, a dentist who has known Dr Sister for many years, said, “We are very pleased to welcome Dr Daniel Sister to The Dentist Gallery.

Daniel is a pioneer of medical aesthetics and his dedicated approach to researching and developing new, safe, effective treatments sits perfectly alongside our unique, state of the art dental practice.”

If you want to see your clinic featured online or in an upcoming issue of the journal email editorial@aestheticsjournal.com

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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Should Dermal Filler be a POM? Aesthetics looks at the results from a recent survey on whether dermal filler should be classified as a POM and investigates how this could impact the specialty Dermal filler use in the UK has been the subject of significant debate in recent years due to extensive media exposure of complications arising after treatment. This is sparking conversations by medical practitioners on how to reduce such complications, with one question being whether dermal fillers should be classified as prescription-only medicines (POMs) instead of medical devices.

The BMJ (formally the British Medical Journal) recently conducted an online poll to find out if its website users thought that dermal fillers should only be available through prescription. Of the 1,054 votes, 877 (83%) said ‘yes’, while 177 (17%) voted ‘no’.1,2 It should be noted that the survey, which was targeted towards doctors, researchers and other healthcare professionals, was relatively small and is purely creating discussion, not reflecting any actions that are actually taking place by the Department of Health.

However, arguably the results reflect the views of many practitioners in the medical aesthetic specialty, several of whom have shared their views on social media.

So, why have professionals voted so strongly for dermal fillers to be made POMs? And, what would be the likely outcome if they were classified differently?

Dermal filler was once a POM Despite dermal filler only being available on prescription in countries such as the US,3 it is currently classified as a class III medical device in the UK.4 Therefore, it only requires CE marking under the Medical Devices Directive for approval to market and does not require a prescription.4 However, this has not always been the case.

In 1981, bovine collagen was approved by the Food and Drug Administration (FDA) as a filling agent5 and according to Amanda Cameron, who was head of Collagen UK at the time, it was only available through prescription. “I was employed by Collagen Corporation from 1989 and it was licensed as a POM only. The status of fillers changed when the Medical Device Directive came into effect in 1995. The directive was implemented to provide a harmonised regulatory environment for medical devices sold within the EU.6 Since then, all fillers in the UK have been classified as a medical device,” she explains.

Consultant plastic surgeon and clinical director at the Private Clinic and Cosmetic Courses, Mr Adrian Richards, remembers using collagen in his clinic. He explains, “When I began using dermal fillers, the mainstay of treatment was based on collagen. At the time, we were less aware of the potential long-term implications and complications that can occur as a result of filler treatment. Now, most dermal fillers are based on hyaluronic acid and many contain a POM – lidocaine, a local anaesthetic agent.” While some people

Aesthetics aestheticsjournal.com

argue that dermal filler shouldn’t be a POM as some do not contain lidocaine and therefore does not have a pharmacological effect on the body, Mr Richards says, “In my opinion they should all be classified as POMs whether they contain local anaesthetic or not.

This is because they are injected under the skin and have the potential to cause adverse reactions.”

Concerns with filler classification According to practitioners interviewed for this article, the main issue concerning filler being classed as a device, rather than a POM, is that it can enable people without medical training to have access to the products. Sharon Bennett, independent nurse prescriber and chair of the British Association of Cosmetic Nurses, says, “Medical professionals have grave concerns over products being available to anyone. The practice puts patients at risk in terms of not being properly and clinically assessed beforehand, as well as for the management of a complication occurring during or after treatment, such as necrosis, delayed onset nodules, infection or even blindness, as the non-medical practitioner will not be able to manage it.”4,7 A number of official recommendations have also suggested change.

In 2013, the Keogh review stated that, “Legislation should be introduced to classify fillers as a prescription-only medical device,”8 and recently, The Nuffield Council on Bioethics published similar recommendations. It said, “We recommend that the Department of Health bring forward stand-alone legislation to make all dermal fillers prescription-only. The Council believes it is unethical that there is nothing to stop completely unqualified people from providing risky procedures like dermal fillers.”9,10 Along with these concerns, Mr Richards believes that there are

Social media responses to the The BMJ survey Mr Taimur Shoaib “Fillers, once injected, act like devices, but the complications are managed often with prescription drugs. I wonder how the people who are currently prescribers who weren’t prescribers 5 years ago would have voted 5 years ago if the same survey had been run?”

Mr Ahmed Ali-Khan “I agree fillers should be regulated better but they are not a medicine. They have no pharmacological effect on the body.

Currently they are classified as a ‘device’. Not perfect, but accurate in the same respect a ‘breast implant’ is also one.”

Ms Nora Nugent “Nonsensical and dangerous that fillers are not POM. It would at least ensure that people carrying out dermal filler procedures have a medical/healthcare background and some medical knowledge or training.”

Claudia McGloin “I’d love to hear the reasons from the people who voted no as to why they did? Are they non-health professionals or non-prescribers?”

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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“Medical professionals have grave concerns over products being available to anyone” Sharon Bennett

also issues when advertising dermal fillers. He says, “It is illegal to advertise a POM directly to the public in the UK, but as dermal fillers aren’t classified as POMs, they can be advertised. In my opinion, this is a problem because I believe that a medical professional is the best person to advise and discuss with the patient the best solution for them, as opposed to the patient coming to them because they have read about the treatment in the newspaper.”

Although restricting advertising might mean that clinics could have challenges in communicating their services to the public, Bennett says that it could have a positive effect overall for the specialism, “Reducing the advertising of fillers would help in inhibiting the cutprice offers that we see frequently happening, which are regarded as enticement.”

What could happen if filler become a POM? If dermal fillers were to become POMs, Bennett notes that there will be both positive and negative implications that practitioners should consider. “It would place restrictions on non-medical practitioners from accessing and administering filler treatments and patients will be more likely to be counselled correctly, in a more clinical manner.” Mr Richards says another positive is that it could improve the safety of products due to scrutiny in testing as well as reduce the high number of fillers, which can make it hard for practitioners to determine which are the safest to use. “POMs are tested more than devices.11 In the US, there are only a small number of fillers that are approved by the FDA, whereas here all that fillers need is a CE mark and there is much less testing. This means that a new filler can be on the market very quickly,” he says. However, if dermal fillers were to become a POM, Bennett notes that there are other considerations that practitioners should take into account, which may negatively impact the specialty.

“From a nurse’s perspective, it would make working difficult for those who don’t yet have their prescribing qualification and there are many excellent nurses out there who are non-prescribers,” she explains.

Bennett also notes that, “People need to remember that just because you are a prescriber, it doesn’t mean you are an experienced injector or competent. A prescriber can prescribe for anyone who is legally allowed to inject but those who prescribe must be able to evidence their competence in the very procedure they prescribe for. Policing this is exceptionally difficult.” She adds, “The other consideration is that it could open the door to ‘career prescribers’, who will make money from prescribing, and potentially push the practice underground even more if it’s made into a POM. Non-medics will still manage to get hold of it, as we have seen with botulinum toxin.” Finally, Bennett suggests that licensing would also need to be considered, “With a POM, the medication will be licensed for a particular use, so with fillers, I suspect, it would be similar, which would probably mean that it will be used offlicence.” As discussed, this licence is likely to be harder to get, which Bennett says could reflect on the costs of the product. She explains, “It would be economically more challenging for manufacturers – they would need to produce significant evidence to support licensing.

Aesthetics

Of course, it could reduce the number of fillers available to us, and therefore restrict the market, leading to a likely increase in costs to practitioners and then patients.”

Is making filler a POM the answer?

Many medical practitioners agree that there are benefits, but that making filler a POM is not the only answer. Mr Richards says, “I think this whole specialty needs to be more regulated. In the UK it’s like the gold rush, it’s a young industry and it’s growing so quickly that we haven’t had the chance to develop the regulations in proportion. The move towards tougher regulation, with a registry of practitioners and a Level 7 qualification to demonstrate safety, can only be a good thing.”

Bennett agrees that more needs to be done, “I think making filler a POM tidies up a little concern, but it’s not enough. In my opinion, the government should pull their socks up and limit aesthetic practice to those on the General Medical Council, General Dental Council and Nursing and Midwifery Council. Practitioners on these regulatory registers should then equally have to demonstrate evidence of a certain level of accredited training, which again should be within fixed guidelines and regulation. Of course we will have the Joint Council for Cosmetic Practitioners register as well, which will have strict membership criteria, and we do have other voluntary registers too.

Those not on these registers should not be permitted to practice and the public can be directed to specialists.”

Summary Surveys such as those conducted by The BMJ are important in raising awareness and creating discussion amongst the medical community.

Mr Richards says, “My answer to The BMJ survey would mirror the majority of those who responded, in that I think dermal fillers should be POM.” However, Bennett adds, “In a nutshell, I think that we have to be careful what we wish for – making filler a POM isn’t all positive. I think that controlling those prescribing and those who deliver the treatments will be more effective than controlling the medication. So, it ticks a few boxes but it doesn’t tick enough boxes for me, and it won’t address all the problems.” Although for some, there may not be a clear-cut, simple ‘yes’ or ‘no’ answer, others do believe that making dermal fillers available only through prescription could be a step forward in helping to reduce the number of non-medical practitioners performing these treatments. However, until the Department of Health releases any indication of change, this debate remains merely a discussion.

REFERENCES 1. ‘Survey suggests 83% think dermal filler should be a POM’, Aesthetics journal, July (2017), <https:// aestheticsjournal.com/news/survey-suggests-83-think-dermal-filler-should-be-a-pom> 2. The BMJ, ‘Poll Archive’, (2017), <http://www.bmj.com/about-bmj/poll-archive> 3. FDA, Dermal Fillers Approved by the Center for Devices and Radiological Health, (2017), <https:// www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CosmeticDevices/WrinkleFillers/ ucm227749.htm> 4. UK Parliament, ‘HC 163 Regulation of medical implants’, 2013, <https://publications.parliament.uk/pa/ cm201213/cmselect/cmsctech/writev/163/m14.htm> 5. Kontis TC, Rivkin A, ‘The history of injectable facial fillers’, Facial Plast Surg, (2009), 25(2):67-72. <https://www.ncbi.nlm.nih.gov/pubmed/19415573> 6. COUNCIL DIRECTIVE 93/42/EEC, Medical Devices Directive, 1993. <http://www.conformance.co.uk/ adirectives/doku.php?id=medical> 7. Mohammed H.Abduljabbar & Mohammad A.Basendwh, ‘Complications of hyaluronic acid fillers and their managements’, Journal of Dermatology & Dermatologic Surgery, 20:2 (2016), pp.100-106 <http:// www.sciencedirect.com/science/article/pii/S2352241016000050> 8. Keogh, B, ‘Review of the Regulation of Cosmetic Interventions’, Department of Health, (2013), <https:// www.gov.uk/government/uploads/system/uploads/attachment_data/file/192028/Review_of_the_ Regulation_of_Cosmetic_Interventions.pdf> 9. Nuffield Council of Bioethics, ‘Cosmetic procedures practice and promotion cause for serious concern, says ethics think tank’, (2017), <http://www.pressreleasepoint.com/cosmetic-procedurespractice-and-promotion-cause-serious-concern-says-ethics-think-tank> 10. Nuffield Council on Bioethics, Cosmetic procedures: ethical issues (2017) <http://nuffieldbioethics.org/ wp-content/uploads/ Cosmetic-procedures-full-report.pdf> 11. Strouts, P, ‘Medical Devices Vs Pharmaceuticals – A Brief Guide To The Differences’, Hays Life Sciences, <https://social.hays.com/2016/06/21/medical-devices-vs-pharmaceuticals-a-brief-guide-tothe-differences/>

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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Adverse events should be reported. Reporting forms and information for United Kingdom can be found at www.mhra.gov.uk/yellowcard.

Reporting forms and information for Republic of Ireland can be found at https://www.hpra.ie/homepage/about-us/report-an-issue/mdiur.

Adverse events should also be reported to Merz Pharma UK Ltd by email to UKdrugsafety@merz.com or on +44 (0) 333 200 4143.

1. Sundaram H, et al. Comparison of the Rheological Properties of Viscosity and Elasticity in Two Categories of Soft Tissue Fillers: Calcium Hydroxylapatite and Hyaluronic Acid, Derm Surg 2010;1076-0512 2. Instructions for Use (IFU) Radiesse® 3. Schachter D, et al. Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds. Journal of Drugs in Dermatology. August 2016; Volume 15. Issue 8. 1005-1011 4. https://www.accessdata.fda.gov/cdrh_docs/pdf5/p050052s049a.pdf

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Infection Control Practitioners outline the key protocols they follow to restrict the spread of infection and manage any incidents in their clinics following dermal filler injections As dermal filler procedures continue to be regarded as one of the most popular non-surgical aesthetic treatments in the UK, the risk of complications occurring also remains high.

While there are no exact statistics on the number of procedures that take place, or the adverse events that have arisen following filler treatments, numerous media reports and discussions from practitioners suggest that they are not uncommon.

In the space of one week in August, there were two stories describing serious filler complications in Glasgow1 and Barrow2 that hit the national press, as well as reports of a non-medic carrying out aesthetic treatments in a garden shed, which led to debate amongst clinicians on what constitutes suitable premises for injectable procedures.3 In the UK, there isn’t an official protocol on complication management, however there is noteworthy consensus guidance from a number of bodies. The Aesthetics Complications Expert (ACE) Group, established

by Dr Martyn King, has created an evidence-based, peer-reviewed protocol that details the management of acute skin infections,4 while a multi-disciplinary group, supported by Merz Aesthetics, published The Expert Consensus on Complications of Botulinum Toxin and Dermal Filler Treatment, which is detailed further in Dr Michael Aiken’s case study on page 42.5 In addition, consultant, plastic, reconstructive and aesthetic surgeon Mr Dalvi Humzah is in the process of developing a group that will share a consensus on dermal filler complication prevention and management protocols.

According to the practitioners interviewed for this article, along with a lack of appropriate training and understanding of fillers, poor injection technique and not taking a proper medical history, infection is a significant contributing factor to dermal filler complications.

So, Aesthetics asked, what is the safest environment to inject in?

How can a patient’s general health impact their risk of infection? What should you do to prepare the skin prior to treatment? And, how do you manage an infection if it occurs?

Aesthetics

points out that in Scotland, where he practises, improvements are being made to monitor the environment private clinics practise in.

As part of Healthcare Improvement Scotland’s (HIS) regulation of all independent clinics, practices need to adhere to standards that cover decontamination, education on the prevention and control of infections, infection prevention and control policies, procedures and guidance.9 “I think HIS is certainly a way of ensuring that clinics are operating to a good standard of high-quality hygiene – it’s one of the cornerstones of what they’re doing and can only be a good thing for our specialty,” he says.

In England, non-surgical clinics can join the Care Quality Commission (CQC) register, where random inspections will be carried out. However, this is not a requirement for most injectable clinics, apart from those that offer surgical, laser or IPL procedures.10 In addition, practitioners can sign up to private regulation companies where inspections are made and certification given. Baker explains, “They will come and inspect your clinic to ensure you’re adhering to their standards, however there’s no counselling body that is legally bound to come out and routinely inspect clinics.”

Medical history As with all clinical consultations, taking a thorough medical history is imperative to safe treatment. Baker says, “Medical history is absolutely paramount. In my opinion, the first thing that’s important is a really thorough and rigorous medical history and consent process.”

She continues, “There’s a lot of divided opinion in the UK about whether you should treat a patient with autoimmune conditions.

Some practitioners do, and some don’t. In my experience, there is an increasing number of people in the UK who are immune suppressed. They may be taking something for rheumatoid arthritis or a polymyalgia condition, which suppresses their immune system but they are otherwise fit and healthy. Personally, if I’ve identified that a patient is immune suppressed, I’d be extremely resistant to giving them a dermal filler treatment as it will be harder for them to fight off infection. Clinicians have to justify their rationale for why they’ve done it if complications do occur.” Aesthetic nurse prescriber Helena Collier says, “It’s so important for the practitioner to identify previous treatments that the patient may have had. It could well be that the infection was caused by the last practitioner who injected the patient and it has lain dormant. Then you treat and have been as sterile as Before

After

Environment “The spotlight is shifting in terms of the standard of the premises people are practising out of and how clean they need to be,” says aesthetic nurse prescriber Anna Baker. She explains, “If a legal complaint was raised, then investigators would want to know about your clinical setup and how the patient felt about where they were treated. It is likely the patient would be asked, did the clinician wash their hands? Was there a sharps bin? Did they use a sterile field?

From the medicolegal perspective, the patient will have to comment on what they saw first-hand.”6-8 Mr Humzah adds, “The environment is very important. It’s not just cleaning the skin and rolling the sleeves up. Carpeted areas have a higher bacteria count, so you therefore get more bacteria in the air. It is also more difficult to clean, whereas a hard floor is easy to mop down.” Consultant plastic surgeon Mr Taimur Shoaib also mentions that good lighting is important. In addition, he

Figure 1: Before and after images of a female patient who self-referred for treatment of a nodular, inflammatory lesion which appeared several weeks after hyaluronic acid injection to treat the tear trough. The lesion was preceded by non-inflammatory, tender nodules. Culture was positive for coagulase-negative Staphylococcus aureus. The patient was treated with hyaluronidase injections, antibiotic ciprofloxacin 500 bd for two weeks, followed by surgical incision and drainage, as well as LED lamp treatment.

Images courtesy of Dr Ewa Kaniowska – dermatogolist and founder of Derma Pulse in Wroclaw, Poland.*

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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possible, but you could reactivate a previous contamination in the tissue.” Mr Shoaib details the types of questions practitioners should ask their patients. “As well as asking them if they’ve had any aesthetic treatments before, you should find out whether any complications arose, and what they thought of the results. You should also find out if they suffer from cold sores, which are caused by the herpes simplex virus that can spread,12 and shouldn’t inject through active acne due to the risk of spreading bacteria,” he advises. Baker notes that in her practice, she always asks patients if she can inform their GP of the aesthetic treatment they have undergone. She says, “In my consent form I have a section that asks if we can contact their GP to let them know that they’ve had treatment. Half the time we don’t know what people are taking and they may not disclose everything.

It’s so important that we do know in case we have to start prescribing concurrent treatment to the patient.”

In Baker’s experience, GPs have got in touch to advise her of other medication their patient is on, which can help to form her treatment plan for an infection. However, she notes, “It must be consensual – if someone’s not comfortable with informing their GP, then we should respect that.”

Avoiding contamination Personal preparation Nurse prescriber Cheryl Barton says, “I’m a great advocate of going back to basics. As doctors and nurses, we are taught that hand contamination is the primary source of pathogens. Since 2012, guidance has informed us of the ‘bare below the elbow’ mantra – which means exactly that – we need to be bare below the elbows.

Practitioners should be in scrubs, cover cuts and abrasions with waterproof dressings, have short nails, with no nail polish and no jewellery. Most importantly, we should be washing our hands before and after direct patient contact.” The ‘bare below the elbow’ guidance was first outlined in National Institute of Health and Care Excellence (NICE) guidance on healthcare-associated infections in 2012. Barton emphasises that all practitioners should be familiar with its suggestions, which provide advice on, amongst others, hand decontamination, use of personal protective equipment, safe use and disposal of sharps, and general waste disposal.11 Significantly, Barton points out that it is likely to be a disciplinary offence if an NHS practitioner was found to be not adhering to NICE guidance, so questions why an aesthetic practitioner should be exempt.

She emphasises, “Do you know how many pathogens are sitting on somebody’s watch? It’s likely to be hundreds of thousands.

Practitioners should keep hair short and tied back. In addition, they should wear clean scrubs and shouldn’t travel back and forth from work in the same clothing. I have scrubs that I keep here in clinic.”

Treatment preparation To begin treatment, Baker says, “I purposely get the product and sterile pack out in front of the patient – it gives an air of professionalism; it sounds like it’s just for show but it does make an impact.” Mr Humzah adds that practitioners should use an aseptic, non-touching technique, on a clean surface, with a sterile field. He emphasises that areas should not be mixed up as you would be at risk of causing cross contamination. Baker says, “I use a sterile pack for everything, whether it’s a filler or a toxin. Initially I put one pair of sterile gloves on to clean the face. Then, when I’m about to start the procedure and start picking stuff up, I put a new sterile pair on top.

This is so if, for whatever reason, I’ve got to take the sterile pair off,

Aesthetics

I’ve got another pair underneath. The minute you start touching and syringing, you’re ready to go – you should be sterile at that point.”

Collier notes that during treatment, practitioners should be wary of the areas they are touching. “The hair is one of the most contaminated areas; it is full of bacteria and should be covered with a hair net,” she says, adding, “The other thing worth mentioning is the mouth is full of bacteria, so if you put your glove in the patient’s mouth when you’re injecting a lip, you’re really at risk of contamination. You’ve got to stop straight away, remove your gloves, clean your hands, and put fresh gloves on. For me, when I’m working in the perioral area, I don’t massage until the very end and the gloves are disposed of as soon as I’m done – I don’t ever do it in the middle of a procedure.”

Skin preparation All the practitioners interviewed agree that the first thing that needs to be done to prepare the skin for dermal filler treatment is to remove the patient’s makeup. “You have to remove every trace of makeup – not just in the area where you’re injecting, but the whole face,” says Collier.

Mr Shoaib says that a really good disinfectant that kills all known bacteria is needed, before the needle enters the tissue. “There are several topical agents that we use as antiseptic agents. These include chlorhexidine, which can be in a water-based solvent or an alcoholic based solvent. 12 We can also use alcohol solutions such as isopropyl alcohol,” he explains.

While chlorohexidine is acknowledged by this panel of practitioners as the most commonly-used antiseptic solution, Collier says that chlorohexidine can be an irritant to some patient’s skin,13 so has been using the new skin preparation agent Clinisept+ since its release earlier this year. Clinisept+ is a product that contains a stabilised version of hypochlorous (HOCI) acid, which has displayed positive results for disinfection.17 She explains, “It can be used pre, during and post treatment – if someone’s had a filler procedure, cleansing the skin with this reduces the risk of infection hugely.”

Baker agrees, noting, “I’ve come away from using chlorohexidine – I’ve gone over to Clinisept+ because I haven’t found another skin preparation solution out there that’s bactericidal, sporicidal and fungicidal. I’ve yet to find any patient that’s sensitive to it.”

Post treatment Following a dermal filler procedure there are additional protocols that practitioners can follow to continue to reduce the risk of infection. Mr Humzah says that one of the key considerations post treatment is the application of makeup. “Patients often will want to immediately cover the hole made by the cannula with makeup,” he says, continuing, “I’m actually in the process of developing a spray plaster that you can literally spray on top of the hole you’ve made, sealing it off immediately so you can put makeup over it. The idea came from a technique I saw when I was in the Asia – it’s a clear spray that you can wash off and stays on for about a day or so.”

In Baker’s practice, she advises patients not to apply any makeup for the first 24 hours. She also says that she will always spray a patient’s hands with a skin disinfectant before they get off the couch. “Although we tell people not to touch their face, they will!” she says, explaining, “I give them a good spray and tell the patient to rub their hands together until it dries. It leaves their hands, for the best part, as clean as they’re going to be. At least in the clinic room you can say you’ve done everything you can to protect the patient from the risk of infection and they’ve watched you putting disinfectant on their hands.”

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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Diagnosis “Recognition of an infection is the first stage of treatment,” says Mr Shoaib, adding, “Infections can occur early, so within the first few days, or can be late, several weeks or months later. Usually an infection will present as a red, hot, swollen, tender nodule or area.”

Mr Humzah agrees, emphasising that the most important thing to do if a patient presents with an infection is to get it adequately diagnosed.

“The best thing to do is to get a sample and ask a microbiologist to tell you exactly what’s growing in there so you can treat the patient with the right antibiotic or other relevant treatment,” he says. Baker adds, “If a patient presented with an infection, I’d want to get my baseline photographs out, and photograph it there and then. I’d also want a really thorough history of everything they’ve done, everywhere they’ve been – if they’ve been on holiday or out of the country – I will need to get as much information and detail from them as I possibly can.” After she has collated this information, Baker will then look at the infection itself. “If there’s something that’s obviously discharging, I’d swab it and send it off for a histopathology report. Ultimately, I’d always want to link up with an expert – someone who’s got a great deal of expertise in complications,” she explains.

Of course, for practitioners who are working independently, this could be difficult. Baker advises, “Practitioners should strike up a relationship with a local lab, microbiologist or histopathologist within a hospital. It’s likely that they would have to come to some sort of discretionary commercial agreement for doing the culture, analysis and report.”

Mr Humzah explains that it is fairly easy to take a sample of an infected area, saying, “You can literally just put a needle in the area to take some fluid out. It’s whether the practitioner actually has all the necessary microbiology kit that may be challenging.” However, he notes that a lot of GPs will have the kits to do it. “If you can liaise with your local GP, they can probably take the sample. It may mean you need to go with the patient, but it’s relatively easy to get the sample to send to the microbiologist,” he says.

Recognition and management Bacterial infection “For every square inch of the human body, there are approximately 32 million bacteria.14 They’re on our body all the time and most of them don’t cause us problems, but if you take some of those bacteria into an environment where it’s not their home, that’s when they can cause problems,” says Collier.

She explains that one in every three people carry the staphylococcus bacteria harmlessly on their skin; however, if the skin is compromised, for example, through a cut or injection, then the bacteria can get into the body and cause an infection.15 “When we’re injecting filler deep into the dermis, we’re dragging that bacteria right into the body,” says Collier. According to the practitioners, in a healthy person, an infection can lie dormant without the knowledge of the patient or practitioner.

Collier says, “It will sit there quietly, not causing much of a problem, however, a common cause of reactivation is repeat injection, which causes further trauma to the skin. It can be a month, six months, a year or more and suddenly the patient can develop an abscess or hard and thick nodule.”

There are a variety of staphylococcus infections that can occur, which would be most likely to present locally as an abscess, redness, swelling, pain and pus following dermal filler injections and generally respond well to antibiotic treatment.16 However, the

Aesthetics

practitioners agree that it is imperative to correctly diagnosis the problem prior to antibiotic prescription, as it could be more serious than empirical observation suggests.

Biofilms and granulomatous response A biofilm is formed when bacteria joins with other microorganisms such as protein, polysaccharide and DNA.17 As Collier explained in her peer-reviewed paper on biofilms from 2014,18 a biofilm can cause local infection, systemic infection, or a granulomatous or inflammatory response. In her paper, Collier highlighted a study from Narins et al., which suggested that lips may be the highest risk for potential biofilm formation because of the proximity to more than 500 species of bacteria.19 Baker says that biofilms are probably the most feared type of infection because they’re very difficult to diagnose and treat. “There’s no real consensus on how they come about,” she says, explaining, “They can manifest sometimes years after treatment, meaning it can be difficult to pinpoint exactly what’s caused it – especially in patients who’ve had many different fillers and gone to many different establishments as you don’t know what they’ve had done.”

The injection of dermal fillers can also disturb a dormant biofilm, which, in turn, can trigger a granulomatous response.20 Mr Humzah explains, “A granuloma is the reaction of your body, known as a foreign body reaction, where specific cells called giant cells accumulate. A foreign body could be anything – and in the case of aesthetics, is generally filler.” Collier adds, “Your body naturally forms a capsule around the foreign body to protect you, because it doesn’t want the infection to spread anywhere. This then usually presents as a hard nodule in the skin.”21,22 Like biofilms, granulomas are extremely difficult to recognise without a histological diagnosis. “A true granuloma needs to be scientifically diagnosed. It isn’t enough to say it’s probably a granuloma – the only way to say it’s definitely a granuloma is to take a biopsy at a laboratory,” emphasises Collier.

Viruses Mr Shoaib explains that infection can be either bacterial or viral, and one of the most common viral infections is herpes simplex virus, which often presents as cold sores.12 Barton emphasises that in her practice, she tells patients that they should be free of a cold sore for at least two weeks before commencing treatment. She says that practitioners should find out if the patient has a history of herpes simplex virus, explaining, “If it is recurrent, we generally don’t treat them with filler.

Sometimes we give prophylactic antibiotics, which can help prevent a cold sore occurring, but if they’re having recurrent outbreaks then

The injection of dermal fillers can also disturb a dormant biofilm, which, in turn, can trigger a granulomatous response

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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we advise that they see their GP for treatment.” Baker notes that if a viral response is not managed properly, it can escalate. “Herpes in a very severe, aggressive presentation can mask as different things as well, so practitioners should ensure they make a correct diagnosis,” she says.

Treatment Once a diagnosis has been made, only then should clinicians proceed with treatment, according to the practitioners interviewed. “For me, I don’t believe in blind empirical prescribing antibiotics or steroids,” says Baker, explaining, “The danger is, you could just be stalling something that might need to be treated quite urgently.”

As well as potentially masking something that may need alternative treatment, the practitioners are concerned that prescribing antibiotics unnecessarily could build patients’ resistance to the drugs. “I am an antibiotic guardian,” says Barton, who notes that GPs are reducing the amount of antibiotics they prescribe23 and emphasises that aesthetic practitioners should be following suit where appropriate.

Mr Humzah adds, “I’m all for giving people antibiotics if they really need it, but you’ve got to know which antibiotic to give. I always say get an accurate diagnosis before you start a patient on antibiotic treatment so you know exactly what you’re doing.”

Of course, many infections will respond well to antibiotics. Mr Shoaib says that practitioners will often prescribe antibiotics such as clarithromycin or clindamycin for a bacterial infection, while Baker notes that biofilms will usually require long-term antibiotic therapy.

According to Fuente-Núñez et al., there are no approved drugs that specifically target biofilms,24 however research by Dayan et al., suggested that the successful management of biofilm complications includes broad spectrum antibiotics.25 If a granuloma has formed, practitioners recommend using oral or intralesional steroids to reduce the inflammation and reaction around the foreign body. “You should then remove the offending body if possible – so if it’s hyaluronic acid (HA) filler, you can try dissolving the HA with hyaluronidase,” says Mr Humzah. Viruses, on the other hand, generally respond well to antiviral agents such as acyclovir, says Mr Shoaib. As an experienced plastic surgeon, filler infection complications are often referred to Mr Humzah, who sees, on average, one serious infection every other month. He says, “I see them at a much later stage than most people would, I tend to see the ones that haven’t responded or have had a very late diagnosis, when the infection is fairly horrible.” Mr Humzah explains that he treats patients who may have developed a major abscess, where the infection has got really out of control and is affecting a large area of their face. “I get people with lots of fat loss in the face, so we literally have to take them into theatre to remove the filler and let all the pus out. We then test the pus again to ensure there’s nothing growing in there,” he says, adding, “The important thing for practitioners to take away from this is that good, early diagnosis and prompt treatment will often save a patient from having to see me.”

Summary If an infection does present, it can be an unsettling time for both the practitioner and the patient. Collier explains that when consulting patients prior to treatment, she details the risk of an infection and tells patients that, in the event of one occurring, the good news is that they usually respond well to treatment. “It’s very unusual for it not to respond once we’ve identified what it is and know how to treat it appropriately,” she says, adding, “Infection control doesn’t have to be complicated –

Aesthetics

it’s really just about the practitioner understanding their responsibility for safety and taking accountability. It isn’t rocket science – it’s simple infection control at the time of injecting.” Barton adds, “The complacency of practitioners can be pretty worrying – pathogens don’t dabble, they win every time I’m afraid. My role as a healthcare professional is to keep my patients safe and to do that I abide by policies for infection control.”

Baker agrees, emphasising that so many infections could be avoided if just the most basic precautions were taken. For Mr Humzah, raising awareness of the complications that can occur following filler treatment for them is essential. He says, “I think we’ve gone a long time thinking that fillers are something that can be injected and forgotten about. Fillers last a long time; sometimes a year or two years – so we should start treating them like proper implants that we’re putting into the body and being aware of the risks of doing so.” Mr Shoaib agrees, “Especially with the higher volume we’re injecting nowadays – we need to be very careful about maintaining strict hygiene control.”

REFERENCES 1. Salon owner could face prosecution after botched treatments (UK: Glasgow Evening Times, 2017) <http://www.eveningtimes.co.uk/news/15455342.Salon_owner_could_face_prosecution_after_ botched_treatments/> 2. Barrow woman left with unsightly lump on her face following botched cosmetic procedure by family GP (UK: The Mail, 2017) <http://www.nwemail.co.uk/news/barrow/Barrow-woman-left-with-unsightlylump-on-her-face-following-botched-cosmetic-procedure-by-family-GP-03091f43-2426-4bc0-b85c08e74b7a3762-ds> 3. Unregistered DIY Botox clinic exposed operating out of a garden shed (UK: Mirror, 2017) <http://www. mirror.co.uk/news/uk-news/unregistered-diy-botox-clinic-exposed-10977156> 4. Dr Martyn King, Emma Davies RN NIP, ‘Management of acute skin infections’, Aesthetics Complications Expert Group, Reference available upon request.

5. Dr Michael Aiken, ‘Case Study: Managing Infection’, Aesthetics (September 2017), p.42.

6. GMC, Investigating concerns (UK: General Medical Council, 2017) <http://www.gmc-uk.org/concerns/ the_investigation_process/investigating_concerns.asp#GMCinvestigation> 7. NMC, Gathering Information (UK: Nursing & Midwifery Council, 2017) <https://www.nmc.org.uk/ ftplibrary/investigations/our-approach-to-investigating/gathering-information/> 8. GDC, What we investigate (UK: General Dental Council, 2017) <https://www.gdc-uk.org/professionals/ ftp-prof/what-we-investigate> 9. HIS, Summary of Inspection (UK: Healthcare Improvement Scotland, 2017) <http://www. healthcareimprovementscotland.org/our_work/inspecting_and_regulating_care/hei_grampian_ reports/woodend_hospital_aug_17.aspx> 10. CQC, The scope of registration (UK: Care Quality Commission, 2015) <http://www.cqc.org.uk/sites/ default/files/20150428_scope_of_registration_independent_medical_practitioners_working_in_ private_practice.pdf> 11. Dr Cormac Convery, Aesthetic Treatments and Hepres Simplex Virus (UK: Aesthetics, 2017) <https:// aestheticsjournal.com/feature/aesthetic-treatments-and-herpes-simplex-virus> 12. NICE, Healthcare-associated infections: prevent and control in primary and community care (UK: NICE, 2017) <https://www.nice.org.uk/guidance/cg139/chapter/1-Guidance#standard-principles> 13. Antiseptics (US: Encyclopedia.com, 2004) <http://www.encyclopedia.com/medicine/drugs/ pharmacology/antiseptics> 14. Chlorhexidine topical (US: Drugs.com, 2017) <https://www.drugs.com/mtm/chlorhexidine-topical.html> 15. Shannon Kilgariff, ‘Spotlight On: Clinisept+’, Aesthetics (September 2017), p.34.

16. Marianne Neighbors, Ruth Tannehill-Jones, ‘Human Diseases 4th Edition’, Cenage Learning (2005), p.63. <https://books.google.co.uk/books?id=l8oTCgAAQBAJ&pg= PA62&dq=32+million+bacteria+square+inch&hl=en&sa=X&ved=0ahUKEwi65cG_2DVAhXsI8AKHVl6DVkQ6AEINjAC#v=onepage&q=32%20million%20bacteria%20square%20 inch&f=false> 17. Staphylococcal infections (UK: NHS Choices, 2017) <http://www.nhs.uk/conditions/Staphylococcalinfections/Pages/Introduction.aspx> 18. Helena Collier, ‘The role of bacterial biofilms in aesthetic medicine’, Journal of Aesthetic Nursing (December 2014).

19. Narins RS , Coleman WP, Glogau RG, ‘Recommendations and treatment options for nodules and other filler complications’, Dermatol Surg 35 Suppl 2 (2009), pp.1667-71.

20. Anitha B Sadashivaiah, Venkataram Mysore, ‘Biofilms: their role in dermal fillers’, Journal of Cutaneous Aesthetic Surgery (2010), p.20-22. <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2890130/> 21. Jeong Min Lee, Yu Jin Kim, ‘Foreign body granulomas after the use of dermal fillers: pathophysiology, clinical appearance, histologic features and treatment’, Archives of Plastic Surgery (2015) pp.232.239. <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4366708/> 22. Dr Beata Cybulska, ‘Granuloma Management’ Aesthetics (March, 2016). <https://aestheticsjournal. com/feature/granuloma-management> 23. Helping GPs to cut antibiotic prescriptions by 2.6m in just one year (NHS Improvement, 2016) <https:// improvement.nhs.uk/news-alerts/helping-gps-cut-antibiotic-prescriptions/> 24. Fuente-Núñez C de la, Reffuveille F, Haney EF, Straus SK, Hancock REW, ‘New broad spectrum peptide antibiotic targets biofilms’, (2014) <http://tinyurl.com/p9ac2ma> 25. Dayan SH, Arkins JP, Brindise R, ‘Soft tissue fillers and biofilms’, Facial Plast Surg 27(1) (2011), pp.23-8.

Further reading *For more information on this case study and the formation of granulomas, see: Dr Beata Cybulska, ‘Granuloma Management’, Aesthetics (March 2016).

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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Bocouture® (Botulinum toxin type A (150 kD), free from complexing proteins) 50/100 unit vials. Prescribing information:M-BOCUK-0067. Please refer to the Summary of Product Characteristics (SmPC) before prescribing. Presentation: 50/100 units of Clostridium Botulinum Neurotoxin type A, free from complexing proteins as a powder for solution for injection. Indications: Temporary improvement in the appearance of moderate to severe upper facial lines (glabellar frown lines, crow’s feet lines, horizontal forehead lines) in adults ≥18 and <65 years when the Xseverity of these lines has an important psychological impact for the patient. Dosage and administration: For intramuscular use only. Unit doses recommended for Bocouture are not interchangeable with those for other preparations of Botulinum toxin. Bocouture may only be used by physicians with suitable qualifications and proven experience in the application of Botulinum toxin. The intervals between treatments should not be shorter than 3 months. Reconstitute with 0.9% sodium chloride.

Horizontal Forehead Lines: The recommended total dose range is 10 to 20 units; a total injection volume of 0.25 ml (10 units) to 0.5 ml (20 units) is injected into the frontalis muscle in five horizontally aligned injection sites at least 2 cm above the orbital rim. An injection volume of 0.05 ml (2 units), 0.075 ml (3 units) or 0.1 ml (4 units) is applied per injection point, respectively. Glabellar Frown Lines: Total recommended standard dose is 20 units. 0.1ml (4 units) into 5 injection sites (2 injections in each corrugator muscle and 1 injection in the procerus muscle). May be increased to up to 30 units. Injections near the levator palpebrae superioris and into the cranial portion of the orbicularis oculi should be avoided. Crow’s Feet lines: Total recommended standard dosing is 12 units per side (overall total dose: 24 units); 0.1ml (4 units) injected bilaterally into each of the 3 injection sites. Injections too close to the Zygomaticus major muscle should be avoided to prevent lip ptosis.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome). Infection or inflammation at the proposed injection site. Special warnings and precautions: It should be taken into consideration that horizontal forehead lines may not only be dynamic, but may also result from the loss of dermal elasticity (e.g. associated with ageing or photodamage). In this case, patients

may not respond to Botulinum toxin products. Should not be injected into a blood vessel. Not recommended for patients with a history of dysphagia and aspiration. Caution in patients with amyotrophic lateral sclerosis, peripheral neuromuscular dysfunction, or in targeted muscles displaying pronounced weakness or atrophy. Bocouture should be used with caution in patients receiving therapy that could have an anticoagulant effect, or if bleeding disorders of any type occur. Too frequent or too high dosing of Botulinum toxin type A may increase the risk of antibodies forming. Should not be used during pregnancy unless clearly necessary. Should not be used during breastfeeding.

Interactions: Concomitant use with aminoglycosides or spectinomycin requires special care. Peripheral muscle relaxants should be used with caution. 4-aminoquinolines may reduce the effect. Undesirable effects: Usually, undesirable effects are observed within the first week after treatment and are temporary in nature. Undesirable effects independent of indication include; application related undesirable effects (localised pain, inflammation, swelling), class related undesirable effects (localised muscle weakness, blepharoptosis), and toxin spread (very rare exaggerated muscle weakness, dysphagia, aspiration pneumonia).

Hypersensitivity reactions have been reported with Botulinum neurotoxin products. Upper Facial Lines: very common: Headache.

Common: Hypoaesthesia, injection site haematoma, application site pain, eyelid ptosis, dry eye, facial asymmetry, sensation of heaviness, nausea. Glabellar Frown Lines: Common: Headache, Muscle disorders (elevation of eyebrow). Crow’s Feet Lines: Common: Eyelid oedema, dry eye, injection site haematoma. For a full list of adverse reactions, please consult the SmPC. Overdose: May result in pronounced neuromuscular paralysis distant from the injection site. Symptoms are not immediately apparent post-injection. Legal Category: POM. List Price: 50 U/vial £72.00, 50 U twin pack £144.00, 100 U/vial £229.90, 100 U twin pack £459.80. Product Licence Number: PL 29978/0002, PL 29978/0005 Marketing Authorisation Holder: Merz Pharmaceuticals GmbH, Eckenheimer Landstraße 100,60318 Frankfurt/Main, Germany.

Date of Preparation: February 2017. Further information available from: Merz Pharma UK Ltd., 260 Centennial Park, Elstree Hill South, Elstree, Hertfordshire WD6 3SR. Tel: +44 (0) 333 200 4143

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1. Bocouture® 50 units Summary of Product Characteristics (SmPC).

March 2016. Available from: https://www.medicines.org.uk/emc/ medicine/23251.

2. Bocouture® 100 units Summary of Product Characteristics (SmPC).

September 2016. Available from: https://www.medicines.org.uk/ emc/medicine/32426 3. Kerscher M, et al. Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results From a Randomized, Double-Blind, Placebo-Controlled, Phase III study. Dermatol Surg 2015;41:1149-1157 Bocouture® is a registered trademark of Merz Pharma GmbH & Co, KGaA. M-BOC-UK-0107 Date of Preparation July 2017

1 oint

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for the purpose of this article, this hormone is the main focus.5 Oestrogen is synthesised from the androgens androstenedione and testosterone by the enzyme aromatase.6 The main role of oestrogen is to bind to specific cellular oestrogen receptors to control gene expression.7 Oestrogen is responsible for regulation of the menstrual cycle, thickening of the endometrium and the development of secondary sex characteristics in females, such as breast development.5 There are three main types of oestrogen, these are oestrone, oestradiol and oestriol.8,9 In non-pregnant, premenopausal women it is oestradiol that is the most abundant and fluctuates during the menstrual cycle;4 it is the biologically active form of oestrogen.5 Oestrone and oestriol are weaker oestrogens in comparison with oestradiol.10 Compared with oestradiol, oestrone has poorer binding capacity to the sex hormone binding globulin that aids transport of oestrogens around the body and this explains its weaker effect.9 It can, however, be metabolised to form oestradiol.9 Oestriol can act as an antagonist and agonist on oestrogen receptors.9 Oestriol levels in non-pregnant women are barely detectable in the blood and it is not secreted or produced by the ovaries. It is a metabolite of both oestrone and oestradiol.11 Reference ranges for oestradiol in the UK differ only slightly, depending on local guidance. South Dr Michael Barnish and Miss Jonquille Tees Hospitals NHS Foundation Trust, for example, Chantrey discuss the literature surrounding states that levels should be 72-529pmol/L during the the effect of the menopause on skin follicular phase. They then rise to 235-1309pmol/L periovulation and subsequently fall to 205-786pmol/L Background and objectives during the luteal phase.5 For postmenopausal individuals the The menopause is defined as a cessation of menstruation for a period reference range is <118pmol/L.11 This is lower than that expected in of 12 months, and the several years leading up to the menopause children (<130pmol/L) and men (<146pmol/L).11 1 are known as the perimenopause. The age women experience the In premenopausal women, who have not experienced the symptoms menopause is variable, with the average usually falling between 50 of the perimenopause, oestrogens are synthesised in the ovary.12 2 and 53 years in Europe. Research has suggested that ethnicity and During the perimenopausal years, the ovarian activity slows and this socioeconomic status may have a role to play on the average age of results in a decrease of hormone production, including oestrogen. menopause, however more research into these factors is required.2 These peri and postmenopausal women, however, still synthesise This age group often makes up a large proportion of patients for some oestrogen in the peripheral tissues, but at much lower levels medical aesthetic practitioners. It is therefore extremely important to as discussed above.13 understand the physiological changes that occur as a result of the menopause in relation to patientsâ&#x20AC;&#x2122; aesthetic needs.

The decrease in oestrogen production from the ovaries leads to This article will review the processes and effects that occur during the many symptoms associated with the menopause, including the menopause on the cutaneous tissues. Exploring the literature, the those on the cutaneous tissue. These include dryness, atrophy, article proposes to help practitioners understand the relationship of fine wrinkling, poor healing, altered fat distribution and hot flushes.7 menopausal hormonal changes and the skin.

Other symptoms that can arise from these hormone changes include dizziness, heart palpitations, insomnia, anxiety and backache.14 The Oestrogen and the menopause majority of women (85%) experience some of these symptoms, The menopause is the result of a decline and change in hormone usually with an onset that occurs prior to the menopause.8 The levels. The duration of menopause is again very specific to an duration of these symptoms is variable amongst individuals, but can individual, but symptoms of the perimenopause average four last for at least several years after the menopause.8 3 to five years. There are four major hormones that are involved in the regulation of the menstrual cycle, these are oestrogen, Surgical or â&#x20AC;&#x2DC;forcedâ&#x20AC;&#x2122; menopause can occur secondary to surgery, progesterone, luteinising hormone and follicle stimulating chemotherapy or pelvic radiation therapy; it may be due to cancer hormone.4 The latter two hormones are involved in negative treatment or gynaecological surgery.15 In the case of chemotherapy feedback pathways to regulate the oestrogen, progesterone and or pelvic radiotherapy, the resulting menopausal symptoms can testosterone levels.4 be a temporary or permanent.15 These patients are more at risk of The skin changes that begin to appear during the perimenopausal rapid symptoms and signs of the menopause, as onset can occur as years are mainly from a reduction in oestrogen levels and therefore quickly as days or weeks after the surgery.8 Several of the symptoms

Cutaneous Ageing and the Menopause

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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that Nelson et al. studied in a summary of menopausal symptom management included vaginal dryness, mood symptoms, vasomotor symptoms, sleep deprivation, amongst several others.8 They found that these symptoms were more marked during the menopausal years and specifically that vaginal dryness and vasomotor symptoms were the most consistently seen in their study cohort.8

Cutaneous ageing The menopause is an example of intrinsic ageing. This is ageing that occurs as a result of physiological changes that arise over a predetermined period of time.16 Ageing of the skin manifests with atrophy of the epidermis, dermis and subcutaneous fat.10 Within the epidermis, ageing results in a decrease in epidermal thickness, flattening of the dermal papilla and a decrease in melanocyte and Langerhans cell density.17 The ageing dermis has reduced fibroblast activity and a reduction in collagen and hyaluronic acid content.

Combined with elastin fibre fragmentation and decreased blood flow, the dermis atrophies and the cell turnover rate is affected.10 Extrinsic ageing, or environmental influences, including sun exposure, excessive alcohol intake, poor diet, smoking, pollution and sleep, can also affect the rate of skin ageing.9 It is therefore important to take note of a patientâ&#x20AC;&#x2122;s lifestyle, particularly if they are menopausal. The reduction in extrinsic ageing factors can help reduce the cutaneous ageing rate.9

Oestrogen reduction and the cutaneous response Skin dryness Oestrogen plays a role in the growth and repair of dermal capillaries, which carry essential nutrition to the skin, including the epidermal basal layers and the stratum germinativum, also known as the stratum basale.18 A menopausal-induced reduction in oestrogen results in a less adequate blood supply to the skin and this results in a slower cell turnover rate.18 The epidermal barrier function is compromised by the slower cell turnover rate and increased transepidermal water loss. This manifests as drier skin, and has an impact on the appearance of the skin, particularly with the visibility of fine lines and wrinkles.4 Although the skin of a menopausal woman is likely to become drier, in some individuals, sebaceous congestion can occur, and this is down to a change in the level of oestrogen.19 In a premenopausal woman, oestrogen stimulates sebaceous glands to secrete a thinner type of sebum. This is less likely to cause congestion within the pores of the skin and is commonly known as the anti-acne effect.19 With the reduction of oestrogen during the menopause, testosterone levels rise as a result of a lack of inhibition from the oestrogen.19 Testosterone stimulates sebaceous glands that secrete a thicker sebum, which can also lead to congestion within the skin. This, in turn, may prompt potential acne in some women.19 Skin thickness Skin atrophy is another consequence of reduced oestrogen levels.

Brincat et al. looked at the skin of 66 postmenopausal women, who had not previously received any treatment and the decline in thickness following the menopause. They state that the thickness of the skin decreases by 1.13% per year following the menopause.

Alongside this is a 2% collagen loss per year.20 Another study by Affinito et al. found that collagen levels could decrease by up to 30% in the initial five years following the onset of the menopause.21 It is interesting to note that according to Brincat et al. the decrease

Aesthetics

Affinito et al. found that collagen levels could decrease by up to 30% in the initial five years following the onset of the menopause in skin collagen and the reduction of bone mass occur at similar rates throughout the perimenopausal years.13 Oestrogens have a role in the synthesis and maintenance of skin proteins, collagen and elastin.16 The reduction in oestrogen production therefore impacts on the formation and repair of collagen and elastin within the dermis of the skin, resulting in thinner, less elastic skin.16 Facial fat loss Another role of oestrogen is to stimulate the deposition of fat evenly throughout the female body.22 Following the menopause and the reduction of oestrogen levels, these fat deposits are redistributed in a high concentration on the abdomen, buttocks and thighs.22 This explains the loss of facial fat and fat from the breast tissue during this time period. The underlying reason for this is not fully understood.23 This distribution results in the loss of fat that supports the face, neck, upper limbs and breasts. The resulting outcome is that of wrinkled, lax skin that has lost its underlying supporting fat, which reduces facial volume.15 Selective reduction of the deep fat pads with normal ageing leads to descent of the overlying superficial fat, contributing to the ptotic appearance in ageing.24 This includes the nasolabial fold and other folds in the lower facial third. These signs are generally amongst the most concerning signs of ageing for patients and they often seek aesthetic procedures to manage these changes through the administration of facial fillers or surgery.

Skin pigmentation Oestrogen has a role within the regulation of skin pigmentation, alongside a multitude of other hormones.25 It does this by maintaining the melanocytesâ&#x20AC;&#x2122; structure and function, as well as being involved in regulating the secretion of melanin.25 There is also an increase of cutaneous pigmentation and worsening of melasma during pregnancy or after the administration of the oral contraceptive pill, when there are elevated ovarian and pituitary hormones.25,26 Maintenance of melanocyte structure and function is affected by oestrogen deficiency and this correlates with a reduction in quality and quantity of melanocytes.25 With fewer melanocytes, there is a reduction in melanin production, the skin appears lighter and it is more vulnerable to UV damage.27 This highlights the importance of wearing a high skin factor sunscreen, particularly following the menopause.

Following decline in oestrogen levels, the remaining unregulated melanocytes can produce melanin at an uncontrolled rate and distribution, so this manifests on the skin as age spots and small areas of hyperpigmentation.28 UV exposure can further enhance this.28 Controversially, there are suggestions of a possible relationship

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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between oestrogen deficiency and malignant melanoma, given the hormonal actions on melanocytes.28 Durvasula et al. hypothesise that the mean age of presentation of malignant melanoma in the female population is in the early 50s and this age correlates with the onset of menopause. This is yet to be fully understood and there is little evidence to suggest this link.28

Treatment option overview Aesthetic practitioners routinely manage the effects of ageing on the face and, generally, a large proportion of work is with menopausal patients. There are several options for patients who want to avoid surgery to improve their appearance during the perimenopausal years and the postmenopausal years that follow.

Non-surgical management includes the use of dermal filler injections that support facial tissues and replenish volume from fat loss and thinning skin. Injection of platelet rich plasma (PRP) into the skin can implant growth factors, such as platelet-derived growth factor, transforming growth factor and vascular endothelial growth factor.29 These factors regulate cell proliferation, differentiation and help accumulate the extracellular matrix.30 This can counteract the cell and collagen loss, as discussed previously, that occurs after the menopause by promoting skin rejuvenation.30 Non-invasive techniques using radiofrequency and high intensity focused ultrasound are growing in popularity and aim to promote skin remodelling, collagen production and skin tightening.31 Obviously, hormone replacement therapy (HRT) is in widespread use as a mainstay in menopausal symptom management. A discussion around HRT is beyond the remit of this paper, however HRT has been shown to increase epidermal hydration, skin elasticity and skin thickness.32 It has also been shown to reduce skin wrinkles.33 Furthermore, the content and quality of collagen and the level of vascularisation is enhanced.20 Topical treatments With the ever-changing hormonal fluctuations that can occur during the peri or postmenopause period, the professional challenge is to address each patientâ&#x20AC;&#x2122;s skincare needs. Revision of the home skincare regimen and professional treatment remedies can help to support the skin and control the effects of fluctuating hormones. Antioxidants, pigment regulators, growth factors and DNA repair enzymes are all key ingredients that should be considered in the management of menopausal skin. These ingredients aim to manage and correct the issues of menopausal skin ageing, as discussed earlier. Growth factors have a similar role to those found in PRP and aim to reverse the structural impact of ageing following reduction in oestrogen.

Similarly, DNA repair enzymes help to maintain the cells of the skin to counteract damage occurred from the withdrawal of oestrogen.34 Pigment regulators, such as hydroquinone, can help to reduce the impact from pigmentation associated with changes to hormonal levels.35 It works by inhibiting melanogenesis and therefore reducing the amount of melanin that can pigment the skin.36 The basis of antioxidant skin therapy is to reduce the number of free radicals within a cell that are believed to contribute to ageing.

Topically applied antioxidants have been shown to improve skin appearance.37 When more than one antioxidant is applied to the skin then this appears to have better outcomes.38 When a topical antioxidant and an oral antioxidant are applied simultaneously this also seems to show better outcomes, from local and systemic response.38 It is important to note that there is a lack of human-based

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controlled clinical trials researching the effects of topical antioxidants and ageing, which raises concerns regarding the efficacy of them.38 Despite this, research has not shown to have detrimental side effects following administration of topical antioxidant formulations.38 Topical oestrogen and managing pigmentation Despite oestrogen decline having such an impact on the skin, there is little evidence of topical oestrogen being effective for the reduction in pigmentation. Studies that have explored the relationship between photoaged skin and the application of topical oestrogen have found little or no improvement of pigmentation.37,38 Schmidt et al. actually reported increased pigmentation on the face, following topical applications.37,38 Therefore, it is not a practised procedure within the aesthetic industry. The common use of oestrogen topical agents is currently controversial because it has been suggested that it may lead to increased risks of contracting certain hormonerelated diseases, such as some breast cancers, following years of literature on hormone replacement therapy and such diseases.33 Ultimately the use of topical oestrogen requires further research to determine whether this can be a safe and effective management of pigmentation or other signs of ageing.

Lifestyle advice It is also vital to manage preventative measures with peri and postmenopausal patients. Lifestyle advice to minimise the impact on extrinsic ageing should be fully discussed and advice on avoiding such factors as sun exposure and smoking given. Such advice should include the promotion of high factor sunscreen, cessation of smoking, excessive consumption of alcohol and reduction of nutritionally poor diets.

Conclusion Menopause can be a distressing time and many female patients do not expect many of the described symptoms as they are often ill informed. This is where aesthetic practitioners have an opportunity and responsibility to support this group of patients. There is clear evidence to suggest that menopause has a significant impact on the cutaneous tissues. We can advise our patients at the perimenopausal stage, discussing prevention through the modification of extrinsic ageing factors. There are several treatment options for the patients that would aesthetically support to correct the signs of ageing that occur in the perimenopause period and beyond.

Dr Michael Barnish, a graduate of Lancaster University, is the associate doctor at Expert Aesthetics by Dr Jonquille Chantrey in Cheshire. He specialises in aesthetic treatments with focus on skin rejuvenation and antiageing.

Dr Barnish is also the medical director for REVIV UK. He teaches internationally on micronutrition and IV Therapy. Miss Jonquille Chantrey has more than 14 yearsâ&#x20AC;&#x2122; experience in aesthetics and surgery. An international key opinion leader she has lectured throughout Europe, Russia, Australia, the US and Asia. As a principal investigator in multiple Phase 2 and 3 trials, she has coauthored peer reviewed papers in Plastic and Reconstructive Surgery and The Lancet.

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

Aesthetics REFERENCES 1. Soules MR, Sherman S, Parrott E, Rebar R, Santoro N, Utian W, et al. Executive summary: Stages of Reproductive Aging Workshop (STRAW) Fertil Steril. 2001;76:874–8.

2. N. Siseles, D. Tan & P. Villaseca, Age of menopause and impact of climacteric symptoms by geographical region S. Palacios, V. W. Henderson, Climacteric pp. 419-428 | Received 26 Jan 2010, Accepted 27 Jun 2010, Published online: 07 Aug 2010 3. Nananda F, Guthrie, Janet R, Mary & Dennerstein, Lorraine, Duration of vasomotor symptoms in middle-aged women: a longitudinal study Col, Menopause: May/June (2009) - Volume 16 - Issue 3 - pp 453-457 4. B M Sherman and S G Korenman, Hormonal characteristics of the human menstrual cycle throughout reproductive life. J Clin Invest. (1975) Apr; 55(4): 699–706.

5. South Tees Hospitals, NHS, Oestradiol, (2017) <https://www.southtees.nhs.uk/services/pathology/ tests/oestradiol/> 6. Nelson LR, Bulun SE, Estrogen production and action. J. Am Acad Dermatol. (2001) 45 (3 Suppl): S116–24.

7. Lessey et al. Immunohistochemical Analysis of Human Uterine Estrogen and Progesterone Receptors Throughout the Menstrual Cycle. The Journal of Clinical Endocrinology & Metabolism, Volume 67, Issue 2, 1 August (1988), pp. 334–340 8. Heidi D. Nelson, Commonly Used Types of Postmenopausal Estrogen for Treatment of Hot Flashes Scientific Review, MPH JAMA, (2004);291(13):1610-1620. doi:10.1001/jama.291.13.1610 9. Simon P Newman and Michael J Reed, The role of cytokines in regulating estrogen synthesis: implications for the etiology of breast cancer. Atul Purohit, Breast Cancer Research (2002)4:65 10. Katzenellenbogen et al. Molecular mechanisms of estrogen action: selective ligands and receptor pharmacology. The Journal of Steroid Biochemistry and Molecular Biology Volume 74, Issue 5, 30 (2000), pp. 279-285 11. Tulchinsky et al. Plasma estrone, estradiol, estriol, progesterone, and 17-hydroxyprogesterone in human pregnancy: I. Normal pregnancy. American Journal of Obstetrics and GynecologyVolume 112, Issue 8, 15 April (1972), pp.1095-1100 12. Michael J Reed, Regulation of estrogen synthesis in postmenopausal women AtulPurohit.

Steroids. Volume 67, Issue 12 November (2002), pp. 979-983.

13. Hall G, Phillips TJ, Estrogen and skin: The effects of estrogen, menopause and hormone replacement therapy on the skin. J Am Acad Dermatol. 2005 Oct;53(4):555-68 14. National Institutes of Health State-of-the-Science Conference Statement: Management of Menopause-Related Symptoms. National Institutes of Health. Annals of Internal Medicine; Philadelphia 142.12 (Jun 21, 2005): 1003-13.

15. Elyse E. Lower, Robbin Blau, Paula Gazder, and Rambabu Tummala, The Risk of Premature Menopause Induced by Chemotherapy for Early Breast Cancer Journal of Women’s Health & Gender-Based Medicine. September 1999, Vol. 8, No. 7: 949-954 16. Bergfield WF, The aging skin, International journal of fertility and women’s medicine (1997);42:5766 17. Ashcoft GS, Horan MA, Ferguson MW, The effects of aging on cutaneous wound healing in mammals. Journal of Anatomy. (1995);187:1-26 18. Sator P-G, Schmidt JB, Rabe T, Zouboulis ChC, Skin aging and sex hormones in women – clinical perspectives for intervention by hor- mone replacement therapy. Exp Dermatol (2004): 13 (Suppl.

4): 36–40. Ó Blackwell Munksgaard, 2004 19. Brincat MP. Muscat Baron Y, Galea R, Estrogens and the skin. CLIMACTERIC (2005);8:110–123 20. Brincat et al. Skin collagen changes in postmenopausal women receiving different regimens of estrogen therapy. (1987) Obstet Gynecol. 1987 Jul;70(1):123-7.

21. Affinito P, Palomba S, Sorrentino C, et al., Effects of postmenopausal hypoestrogenism on skin collagen. Maturitas. (1999);33:239–47.

22. C J Ley, B Lees, and J C Stevenson, Sex- and menopause-associated changes in body-fat distribution. (1992) Am J Clin Nutr. 1992 May;55(5):950-4.

23. Toth MJ, Tchernof A, Sites CK, Poehlman ET, Menopause-related changes in body fat distribution.

Ann N Y Acad Sci. (2000) May;904:502-6.

24. Rohrich RJ, Pessa JE, Ristow B, The youthful cheek and the deep medial fat compartment, Plast Reconstr Surg. (2008) Jun; 121(6):2107-12 25. Biology of estrogens in skin: implications for skin aging, Exp Dermatol. (2006) Feb;15(2):83-94.

26. Verdier-Sévrain S, Bonté F, Gilchrest B. Newcomer V D, Lindbert MC, Stenbert T H, Melanosis of the face (‘chloasma’). Arch Dermatol (1961): 83: 284–297.

27. Michaela Brenner and Vincent J. Hearing, The Protective Role of Melanin Against UV Damage in Human Skin Volume 84, Issue 3 May/June (2008) pp. 539–549 28. Durvasula R, Ahmed SM, Vashisht A, et al. Hormone replacement therapy and malignant melanoma: to prescribe or not to prescribe? Climacteric. (2002);5:197–200.

29. Dae Hun Kim et al. Can platelet rich plasma be used for skin rejuvenation? Evaluation of effects of platelet rich plasma on human dermal fibroblast, Ann Dermatol. (2011) Nov;23(4):424-431 30. Freymiller EG, Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg (2004);62:1046.

31. Haim Kaplan & Andrea Gat, Clinical and histopathological results following TriPolla radiofrequency skin treatments, Journal of Cosmetic and Laser Therapy. pp.78-84 Volume 11, (2009) 32. Sator PG, Schmidt JB, Sator MO, Huber JC, Hönigsmann H Maturitas, The influence of hormone replacement therapy on skin ageing: a pilot study, (2001) Jul 25; 39(1):43-55.

33. Phillips TJ, Demircay Z, Sahu M, Hormonal effects on skin aging, Clin Geriatr Med. (2001) Nov; 17(4):661-72, vi.

34. Joi A. Nichols. Santosh K. Katiyar, Skin photoprotection by natural polyphenols: anti-inflammatory, antioxidant and DNA repair mechanisms. Archives of Dermatological Research. March (2010), Volume 302, Issue 2, pp. 71–83 35. Effect of the ethyl ethers of hydroquinone on pigmentation and on the cells of Langerhans.

Dermatologica. 134. 1967. pp:125-128.

36. Kenneth A. Arndt, MD; Thomas B. Fitzpatrick, Topical Use of Hydroquinone as a Depigmenting Agent, JAMA. 1965;194(9):965-967.

37. Creidi P, Faivre B, Agache P et al. Effect of a conjugated oestrogen (Premarin) cream on ageing facial skin. A comparative study with a placebo cream. Maturitas 1994: 19: pp.211–223.

38. Schmidt J B, Binder M, Macheiner W, Kainz C H, Gitsch G, Bieglmayer C H. Treatment of skin ageing symptoms in perimenopausal females with estrogen compounds. A pilot study. Maturitas 1994: 20: pp.25–30.

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Aesthetics Journal

Spotlight On: Clinisept+ Aesthetics explores the use of a new skin disinfectant for aesthetic procedures As an aesthetic practitioner, limiting the risk of infection in patients should be a fundamental focus of delivering treatment. Employing an aseptic technique with the use of an effective topical sterilising agent is one way to support this.1,2

high purity version that gives a shelf life of two years, whilst retaining an optimum pH of 5.2-5.8 for ideal skin compatibility.

It does not contain alcohol, is non-irritant, non-cytotoxic and is not susceptible to causing resisitance.7,10

Common skin disinfectants used in aesthetics include aqueous chlorhexidine and 70% isopropyl alcohol solutions,1-3 however, according to surgeon and cosmetic doctor, Miss Sherina Balaratnam, there are potential side effects to these.4,5 Miss Balaratnam explains, “Whilst I know that I am getting great skin disinfection when using something like isopropyl ethanol, what you can expect as a side effect is irritated skin, especially with inflamed or sensitive skin.” She adds, “When it comes to skin disinfection, practitioners are trying to find the best product that will efficiently disinfect and cleanse the skin before any procedure, while, at the same time, not causing irritation.”

Miss Balaratnam, who is on the Clinisept+ advisory board and has been using it since February, explains, “What you have is a widely researched hypochlorous solution that is bactericidal, virucidal, sporicidal, and has anti-inflammatory effects. Furthermore, it allows wound healing to occur more quickly, reduces facial redness in sensitised skin and is non-cytotoxic. This is important for me in my clinic as I see and treat a large number of facial injectable patients who struggle with facial redness, sensitised skin and rosacea, which will become irritated and inflamed following skin disinfection using alcohol-based skin preparation solutions.”

Studies A new solution Clinisept+, launched by distributor AestheticSource in June 2017, is a product that contains a stabilised version of hypochlorous acid (HOCI), which has displayed positive results for disinfection.6-9 Professor J Lorrain Smith et al. first publicised the benefits of HOCI in the British Medical Journal in 1915, stating that ‘the fundamental practical difficulty in the use of hypochlorous is that, in solution, they rapidly lose their strength by decomposition’.6 Due to the challenge of maintaining storage of HOCI in its natural form, it has not previously been commercially available.7 However, the UK manufacturer of Clinisept+, Clinical Health Technologies Ltd, has managed to create a stabilised,

Although no clinical studies have been conducted on Clinisept+ in the aesthetics specialty to date, according to the manufacturer, the technology has been used for several years in the piercing sector, where more than four million procedures have been conducted without post-treatment infection.11 There are also several studies that demonstrate the disinfecting and dermatological benefits of HOCI.6-9, 12,13 In 2007, a paper by Wang et al. studied stabilised HOCI in the form of a physiologically-balanced solution in 0.9% saline at a pH of 3.5-4.0.7 Results suggested that stablised HOCI exerts rapid, concentration-dependent activity against gram-negative and gram-positive bacteria, yeast, and fungal pathogens, as long as the pH range is maintained. There was

Aesthetics aestheticsjournal.com

no evidence of ocular irritation following single installation of HOCI in rabbits and no reports of dermal sensitisation or reaction in guinea pigs.7 Part two of this study by Martin et al. used a standard rodent model of a chronically infected granulating wound to test various preparations of a stabilised form of HOCI.8 Results suggested that 0.01% of the stabilised HOCI with a pH of 3.5-4.0 was an effective topical antimicrobial. Compared to other antimicrobials investigated in this animal model, HOCI was shown to control the tissue bacterial bioburden without inhibiting the wound healing process. It was also associated with improved wound closure.8 In a 2006 study looking at the effects of HOCI on the healing of leg ulcers, Selkon et al. observed 30 patients receiving compression treatment.9 After three weeks, 10 patients achieved a 44% ulcer reduction.

The remaining 20 patients were given HOCI washes for a further 12 weeks; of this, 45% healed and 25% reduced in size by 60%, with all patients reporting to be pain free.

The authors concluded that HOCI washes, as an adjacent therapy, increases healing and rapidly relieves pain.9 According to Clinical Health Technologies, Clinisept+ has been accepted by independent laboratory testing to approved British Standard European Norm (BS EN) standards, where it passed tests to denote its suitably as a skin disinfectant.14 Its safety has also been demonstrated in several papers.15

Use of Clinisept+ in clinic There are two products within the Clinisept+ range, Clinisept+ Prep & Procedure and Clinisept+ Aftercare. Miss Balaratnam explains that in her clinic she uses Clinisept+ across all stages of her patient journey, “This includes skin preparation for preskin imaging to remove make up and oil without causing irritation to sensitised or inflamed skin, compared to standard skin wipes. It is essential to prepare skin for injectable dermal filler treatment to reduce the risk of bacterial infection and potential biofilm formation. I also use it pre-laser and skin resurfacing procedures to disinfect the skin pre-treatment as well as post-treatment to encourage a faster wound healing, to speed up recovery time and minimise posttreatment erythema,” she says.

In addition, Miss Balaratnam recommends applying Prep & Procedure after the treatment, “When I finish a procedure, I apply Clinisept+ across the face with a swab, and this not only cleanses the skin

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

Aesthetics

immediately post-procedure, but also reduces the redness that comes following any post-injection trauma and the redness postlasers, which is very beneficial. For post-laser and skin resurfacing procedures, in my experience, the solution has shown to reduce post-treatment erythema and reduce microbial activity without slowing down the wound healing process.” Miss Balaratnam says that the Aftercare cleanser also helps to achieve this, “I give patients a sample of the cleanser and I advise them to use it for up to 48 hours post treatment.”

Clinisept+ for skin conditions As well as skin cleansing and disinfecting, Miss Balaratnam has also been trialling Clinisept+ to treat skin concerns such as resistant pustular rosacea. “As part of a small in-clinic trial, we took six patients off their existing skincare and put them on Clinisept+ Aftercare twice a day, morning and night, followed by a broad spectrum SPF,” she explains, adding, “After just seven days we can see excellent results with the skin imaging system, showing an improvement in pustular rosacea, facial redness and an overall improvement in patient satisfaction.”

Summary Miss Balaratnam says that skin disinfection is an integral part of all aesthetic pre-procedure care, and praises the fact that Clinisept+ can support this. She concludes, “I would definitely advise all colleagues to place focus on preparing skin for cosmetic procedures. You want to use the best product that is going to deliver the best results, with the best recovery time, in order to minimise the risk of infection, transmission of infection. This product represents an evolution and is a game changer to skin disinfection here in the UK.” REFERENCES 1. David Funt & Tatjana Pavicic, ‘Dermal fillers in aesthetics: an overview of adverse events and treatment approaches’, Clin Cosmet Investig Dermatol, 2013; 6: 295-316.

2. Mohammed H Abduljabbara, Mohammad A Basendwh, ‘Complications of hyaluronic acid fillers and their managements’, Journal of Dermatology & Dermatologic Surgery, 20:2, 2016, pp.100-106.

3. Davies, E, ‘Management of Acute Skin Infections’, Aesthetic Complications Expert Group, <http:// acegroup.online/wp-content/uploads/2016/01/Acute-Skin-Infection-v1.1.pdf> 4. Drugs.com, ‘Chlorhexidine topical Side Effects’, 2017 <https://www.drugs.com/sfx/chlorhexidinetopical-side-effects.html> 5. FDA, ‘FDA Drug Safety Communication: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate’, 2017. <https://www.fda.gov/Drugs/DrugSafety/ ucm530975.htm> 6. Lorrain Smith, A. Murray Drennan, Theodore Rettie and William Campbell, ‘Experimental Observations on the antiseptic action of Hypochlorous Acid and its application to wound treatment,’ Br Med J, Jul 1915; 2:129 – 136.

7. L. Wang et al. ‘Hypochlorous Acid as a Potential Wound Care Agent: Part I. Stabilized Hypochlorous Acid: A Component of the Inorganic Armamentarium of Innate Immunity, Journal of Burns and Wounds, April 2007.

8. Martin C, Robson et al, ‘Hypochlorous Acid as a Potential Wound Care Agent: Part 2. Stabilized Hypochlorous Acid: Its Role in Decreasing Tissue Bacterial Bioburden and Overcoming the Inhibition of Infection on Wound Healing’, Journal of Burns and Wounds, April 2007.

9. Selkon JB, Cherry GW, Wilson JM, Hughes MA., ‘Evaluation of hypochlorous acid washes in the treatment of chronic venous leg ulcers’, J Wound Care, 2006 Jan;15(1):33-7.

10. Consulting Room, ‘Introducing Clinisept...The Ultimate Skin Disinfectant?’, The Consulting Room Member Magazine, June 2017.

11. Data on file at Medical Health Technologies and AestheticSource.

12. Serhan Sakarya, Necati Gunay, Meltem Karakulak, Barcin Ozturk, Bulent Ertugrul, ‘Hypochlorous Acid: An Ideal Wound Care Agent With Powerful Microbicidal, Antibiofilm, and Wound Healing Potency’, Wounds, 2014;26(12):342-350.

13. Mimi Mekkawy & Ahmed Kamal, ‘A Randomized Clinical Trial: The Efficacy of Hypochlorous Acid on Septic Traumatic Wound’, Journal of Education and Practice, 2014, 5:16.

14. Data on file at Medical Health Technologies and AestheticSource. BS EN efficacy testing include, but not limited to, BS EN1040 – Bactericidal, BS EN13727 – Bactericidal, BS EN1276 – Bactericidal, BS EN1650 – Fungicidal, BS EN14476 Virucidal, BS EN13704 – Sporicidal 15. Data on file at Medical Health Technologies and AestheticSource. Human Repeat Insult Patch Testing AMA Laboratories New York, USA & Non-Toxicity and Non-Mutagenicity Testing.

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THE FINALISTS ARE ANNOUNCED! Once again, the time has come to reveal the leading aesthetic individuals, teams, companies, products and innovations that have made it to the prestigious finalist stage of the Aesthetics Awards. As always, it was extremely difficult to whittle down the entries as the standard of applications was exceptionally high.

The voting and judging process is open from September 1 and will close on October 31, with winners announced at the Park Plaza Westminster Bridge Hotel in London on December 2. Commended and Highly Commended finalists will also be honoured at the ceremony, which will play host to approximately 700 guests from the medical aesthetic profession.

CHO O S I NG TH E W I N NE R S JUDGING More than 50 esteemed aesthetic professionals form the Aesthetics Awards judging panel. Six judges will be assigned to each category, chosen specifically for their knowledge and expertise in that area, as well as to ensure that conflicts of interest are avoided. The full list of judges can be found on the Aesthetics Awards website.

VOTING â&#x20AC;&#x201C; HAVE YOUR SAY! As always, Aesthetics readers are encouraged to take part in the winner selection process for certain categories. Login to www.aestheticsawards.com to view all the finalists and cast your votes today!

Select categories will be decided upon by reader votes and a judging panel, while others will be decided by judges alone. Please see details under each category for clarification.

Voting and judging will close on October 31 and there will be no opportunity to vote after this date. Voting is IP address monitored and individuals can only vote once. Multiple votes under the same name will be discounted from the final total.

Multiple votes from within organisations will also be monitored.

B O OK N OW TO AVO I D D I SAP POI N T M EN T ! WWW.A ES T HET I CS AWA R DS.COM

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COMPANY FINALISTS

THE HEALTHXCHANGE AWARD FOR SALES REPRESENTATIVE OF THE YEAR

BEST CLINIC SUPPORT PARTNER

Paula Dene (Merz Aesthetics) Karen Houlihan (Merz Aesthetics) Nik Kane (Beamwave Technologies) Kerry Lavin (Merz Aesthetics) Deirdre MacMahon (Merz Aesthetics) Lorraine McLoughlin (Med-fx) Julie Purdy (Galderma UK Ltd) Kelly Tobin (Med-fx)

Aesthetic Response Blank Canvas Cosmetic Insure EBWPR IMAGE BOX PR Kendrick PR Lucy Dartford Public Relations RKM Communications

WHOLESALER OF THE YEAR

BEST UK SUBSIDIARY OF A GLOBAL MANUFACTURER

Church Pharmacy Med-fx Wigmore Medical

ABC Lasers Lipoelastic LTD. Lumenis Merz Aesthetics Syneron Candela Venus Concept UK

DISTRIBUTOR OF THE YEAR ABC Lasers AestheticSource Church Pharmacy Consulting Room Harpar Grace International Healthxchange Pharmacy Med-fx Medical Aesthetic Group Naturastudios

BEST UK-BASED MANUFACTURER 3D-lipo Ltd Clinical Health Technologies Lynton

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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PRODUCT FINALISTS COSMECEUTICAL/SKIN TREATMENT OF THE YEAR Dermaceutic Laboratoire Elizabeth Arden Pro Epionce H.A. Intensifier HydraFacial NeoStrata Obagi Medical Oxygenetix ZO Skin Health

THE HARLEY ACADEMY AWARD FOR INJECTABLE PRODUCT OF THE YEAR Belotero® Juvéderm® VOLITE Princess® Dermal Fillers PROFHILO Radiesse RRS® Xela Rederm

ENERGY TREATMENT OF THE YEAR

THE BARRY KNAPP AWARD FOR PRODUCT INNOVATION OF THE YEAR, SUPPORTED BY MEDICAL AESTHETIC GROUP

Accent Prime CoolSculpting™ Dermalux LED Dermapen™ ENDYMED HydraFacial Non-Surgical Blepharoplasty – Plexr Ultherapy® ULTRAcel

3DOSE Unit Dose Injector Biofibre Hair Implant Clinisept+ Novoxel Tixel ProLon UK

TRAINING PROVIDER FINALISTS

THE ENHANCE INSURANCE AWARD FOR BEST INDEPENDENT TRAINING PROVIDER

Enhance Insurance

|

Advice

|

Support

BEST SUPPLIER TRAINING PROVIDER

Acquisition Aesthetics Aesthetic Training Academy Cosmetic Courses Dalvi Humzah Aesthetic Training Harley Academy Inspired Cosmetic Training MATA Oculo-Facial Aesthetic Academy

AestheticSource Healthxchange Pharmacy Lynton Lasers Skinbrands Wigmore Medical

REGIONAL CLINIC FINALISTS

THE COSMEDIC PHARMACY AWARD FOR BEST CLINIC MIDLANDS & WALES Air Aesthetics Cellite Clinic Limited Harley Skin and Laser Outline Clinic SPECIALIST SKIN CLINIC The Grove Skin Clinic

THE JOHN BANNON AWARD FOR BEST CLINIC IRELAND Ailesbury Clinic Amara Aesthetics ClearSkin Medical Skin Clinic Dundrum Cosmetic Clinic Elite Aesthetics Clinic Renew Aesthetic Clinic The Laser and Skin Clinic

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THE DERMALUX AWARD FOR BEST CLINIC LONDON

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BEST CLINIC NORTH ENGLAND

Dr Leah’s Cosmetic Skin Clinics Health & Aesthetic Clinic Juvea Aesthetics LINIA Skin Clinic London Professional Aesthetics Medicetics The Cadogan Clinic

DIANE NIVERN CLINIC LTD Discover Laser Good Skin Days LoveSkin Sarah White Laser & Aesthetics Ltd Surface Clinic The ESHO Clinic

THE IS CLINICAL AWARD FOR BEST CLINIC SOUTH ENGLAND

BEST CLINIC SCOTLAND

Aspire Clinic Barstable Medical Clinic Bella Vou Cosmedica Beauty Medical Aesthetics Cosmex Clinic HARPENDEN SKIN CLINIC health + aesthetics Medikas Medispa Perfect Skin Solutions S-Thetics Ltd

Age Refined Medical Cosmetic Clinic Clinetix dermalclinic Frances Turner Traill Skin Clinic Innocent Aesthetics Ltd La Belle Forme RENU SKIN CLINIC LTD Temple Medical

OTHER CLINIC FINALISTS

THE AESTHETICSOURCE AWARD FOR BEST NEW CLINIC UK & IRELAND Chester MediSPA Cliniva Medispa Dr Mayoni Dr Nestor’s Medical Cosmetic Centre Emma Chan Ltd River Aesthetics The Clinic Newton Place Yuva MediSpa

THE PROFHILO AWARD FOR BEST CLINIC GROUP UK & IRELAND (3 CLINICS OR MORE) La Belle Forme Premier Laser & Skin The Laser and Skin Clinic The Women’s Health Clinic VIVA SKIN CLINICS

THE ALUMIER LABS AWARD FOR BEST CLINIC GROUP UK & IRELAND (10 CLINICS OR MORE) Courthouse clinics National Slimming & Cosmetic Clinics sk:n clinics The Harley Medical Group The Private Clinic Therapie Clinic

THE CONSENTZ AWARD FOR CLINIC RECEPTION TEAM OF THE YEAR Cliniva Medispa Cosmex Clinic Dr Nestor’s Medical Cosmetic Centre Frances Turner Traill Skin Clinic Health & Aesthetic Clinic Outline Clinic Select Medical Group Temple Medical

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CLINIC, COMPANY OR ORGANISATION FINALISTS

THE PHI CLINIC AWARD FOR INDUSTRY INITIATIVE OF THE YEAR Aesthetic Complications Expert Group Aesthetic Nursing Revalidation Mentor Programme AIIVL Consensus Group BCAM Academy DH Aesthetic Training & MATA Level 7 Fast Track The Esho Initiative

INDIVIDUAL PRACTITIONER FINALISTS

THE INSTITUTE HYALUAL AWARD FOR AESTHETIC NURSE PRACTITIONER OF THE YEAR Anna Baker Michelle McLean Jacqueline Naeini Jackie Partridge Simone Sansom Lou Sommereux Karen Urquhart Libbie Wallace

THE SCHUCO INTERNATIONAL AWARD FOR OUTSTANDING ACHIEVEMENT IN MEDICAL AESTHETICS The exceptional accomplishments and significant contribution to the profession by an individual with a distinguished career in medical aesthetics will be recongised with the trophy for Outsanding Achievement in Medical Aesthetics. The winner of this category will be announced at the ceremony and is not open to entries.

THE SKINCEUTICALS AWARD FOR MEDICAL AESTHETIC PRACTITIONER OF THE YEAR Miss Sherina Balaratnam Dr Miguel Montero Garcia Dr Kate Goldie Dr Steven Harris Dr Beatriz Molina Mr Marc Pacifico Dr Tapan Patel Dr Sam Robson Mr Taimur Shoaib Dr Daniel Sister Dr Patrick Treacy

D O N’ T M I SS YO U R C H AN CE TO AT T EN D T HE M OS T PR ES T I GI OUS AWAR D S C ER EM ON Y I N M EDI CA L A ES T HET I CS…

BOOK NOW! Individual ticket: £275 +VAT Table of 10: £2,600 +VAT

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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It is thought that a late presentation of infection is likely due to the formation of a biofilm around the dermal filler implant. A biofilm is an aggregate of microorganisms that are joined together and usually form on solid surfaces, which are exposed or submerged in water. Unfortunately biofilms protect the bacteria within them from oral antibiotics, meaning that antibiotic regimens will often need to be extended in duration.

Treatment can therefore be difficult.3

Case study A female in her 50s (Patient A) was referred to me for management of a complication which occurred following a full facial treatment with a popular non-volumising HA two months previously. On the same day, she had also received botulinum toxin injections and treatment of the nasolabial folds with a different HA dermal filler. This case study will Dr Michael Aicken details his successful treatment document, in chronological order, what the patient experienced thereafter, as well as of a patient for a HA-related infection provide details of how she was successfully Hyaluronic acid (HA) dermal filler treatments are very popular managed for a delayed dermal filler-related infection, presumed to aesthetic procedures,1 therefore it is important that practitioners are be due to the formation of a biofilm. The treatment protocol is based aware of how to handle related complications, however rare. One upon the Expert Consensus.2 such complication is infection, which may require antibiotic treatment.

This article will share a case study that describes the management of a Day 28 post treatment complication following treatment with HA filler.

After 28 days, Patient A had developed an itchy red rash over her whole face. Not wanting to divulge to her GP that she had received an Classification of infection aesthetic treatment, she informed them that she had reacted to a ‘new The most common bacteria to cause HA dermal filler-related cream’ that she had purchased over the counter. Her GP prescribed infection is Staphylococcus aureus.2 Because this is a common skin hydrocortisone cream (a steroid cream), which helped with the itch, so commensal, it is likely that the infection is introduced either at the much so, that the patient decided to stop using the cream after three time of treatment or immediately thereafter, on the early application of days, before switching to an emollient cream. Patient A continued to makeup or other facial treatments. see a recovery of this rash for the following seven days as she applied The Expert Consensus on Complications of Botulinum Toxin and the emollient cream daily.

Dermal Filler Treatment,2 which was published in 2014 and funded

by Merz Aesthetics, was put together by a multi-disciplinary group Day 60 post treatment comprising experienced aesthetic practitioners. It recommends an Patient A then saw the return of an even angrier red rash to both lower aseptic technique for the application of any type of HA injection, cheeks (Figure 1), 60 days following the initial treatment. whether it is a traditional dermal filler or non-volumising HA. With I reviewed the patient and diagnosed her with a delayed HA-related the relatively higher number of injection sites normally required to infection. Due to the pattern of the presenting rash, it appeared that administer non-volumising HA, the risk of infection is likely to be greater the reaction was likely related to the non-volumising HA. During her compared to dermal filler treatments. To avoid infections and other consultation, I took photographs of her face so that I could monitor complications, these steps are suggested by the Expert Consensus: her progress.

• Avoid treating patients with signs of current infection The Expert Consensus guideline suggests that if the infection • Remove makeup or hypersensitivity reaction presents more than two weeks after • Clean the skin with an antiseptic such as chlorhexidine, then allow to dry for 20-30 seconds • Keep needles and syringes sterile throughout treatment • Use clean gloves. Avoid touching non-sterile surfaces during treatment e.g. clinic waste/sharps bucket, treatment couch, computer, outer packaging of dermal filler, fridge door • If using a cannula or long needle, avoid touching it on gloves

Case Study: Managing Infection

Early and delayed infections HA-related infection is generally classified into early (within two weeks of treatment) and delayed (more than two weeks following treatment).2

Figure 1: Patient A presenting with an angry, itchy red rash 60 days after her initial aesthetic treatment.

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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treatment, inflammatory markers should be used to guide response to antibiotics.2 As Patient A’s reaction was localised to the patient’s face and she was systemically well, blood samples were not sent. Instead, a trial of first-line antibiotics were initiated. If she was systemically unwell, I would have referred her to Accident and Emergency for intravenous fluids and urgent blood tests to guide antibiotic treatment.

Based upon this guideline, the advice and management I provided was as follows: 1. Avoid using steroids (oral or topical).

2. Prescribe antibiotics (clarithromycin 500mg twice per day and moxifloxacin 400mg once per day for 14 days). As this patient was allergic to penicillin, I reassured her that neither of the recommended antibiotics was a penicillin.

3. I told Patient A that the affected area would need to be reassessed (ideally, this should include comparison with the photos taken initially) on day three of antibiotics. As the clinic was closed on day three, we arranged a review consultation on day five instead.

If there was an improvement after five days, the treatment plan was to continue with that regimen for another nine days and then it would need to be reviewed again. If the response was still incomplete, antibiotics may have been needed to be continued for up to four weeks in total. If the response wasn’t good after the first five days of antibiotics, I advised that we would need to switch to an alternative antibiotic regimen (clindamycin and tetracycline for two to four weeks), as per protocol (Figure 2).2 Day 65: five days following antibiotic treatment After five days of antibiotics, both Patient A and myself agreed that there had been a significant improvement since day 60. She had tolerated the clarithromycin and moxifloxacin well. She agreed to complete the 14-day course and I prescribed these antibiotics for a further nine days. I also advised her to contact me if the redness returned, became worse or if it did not fully resolve on completion of the full 14-day course of antibiotics. I also reiterated the importance of completing the full course.

Aesthetics

This patient found herself in a vicious cycle, whereby the application of makeup to cover the adverse reaction she had suffered appeared to be making the inflammatory response worse Together we faced a difficult decision at this stage. Our only three options seemed to be: • Break protocol for the infection and stop antibiotics early. This risked the return of an infection that was now contained.

• Switch to another antibiotic for at least 14 days, however we were very close to completing the current course. Also, with this option, there was a risk that the alternative regimen might not be as effective.

• Put up with the generalised skin irritation and complete the course.

The protocol states 10-14 days for this course. This review was on day nine, so finishing it the following evening would technically be a completion of the recommended treatment.

The patient agreed to continue with the antibiotics for 36 hours and thereby complete the full, recommended course. We discussed the following steps as a method of hopefully seeing an improvement in the dermatitis reaction: 1. Continue to keep makeup as minimal as possible.

2. Stop using non-prescribed moisturisers until the symptoms settle as they can contain additives, which might further irritate her skin.

Instead use a simple emollient.5 3. If, following the course of antibiotics, the dermatitis does not begin to resolve, she should consider seeing her GP. I also reiterated that Patient A should be vigilant in case there is a return of the initial rash. We discussed that this occurrence could suggest incomplete treatment of the infection, where she was advised to return to me rather than her GP.

Day 69: nine days following antibiotic treatment Unfortunately, at this review appointment, the patient appeared to have developed dermatitis on her face and on both of her wrists, probably due to her medication.4 This rash was quite different from the previous rash as it was less defined, with a dry looking surface, and was more in keeping with dermatitis than infection. At this stage, understandably, the patient was becoming very frustrated and upset by the symptoms she was experiencing.

I advised the patient that this was a likely side effect of the Redness, heat, pain, swelling, itch antibiotics, but was probably being exacerbated by her application of Clarithromycin 500mg per day (oral) plus makeup and various creams to her moxifloxacin 400mg once per day (oral) face, even though I had advised her not to do this. This seemed to be a Good response at Poor response at day 3, switch to vicious cycle, as the more redness day 3, continue for clindamycin 600mg twice per day (oral) plus she developed, the more makeup another 11 days tetracylin 500mg x 2 (oral) for another 11 days she applied to camouflage it, resulting in even more redness and Poor response – refer to a specialist. Your Complete recovery – stop Partial recovery – irritation. Thankfully, there was no hyaluronic acid provider should be able antibiotics. Consider removing filler extend course of using hyaluronidase if one localised antibiotics to a total of to guide you to a suitably experienced return of the dark red spots on both area of infection 28 days then reassess practitioner, such as a microbiologist sides of the lower face, associated with the initial infection (Figure 1).

Figure 2: Treatment protocol for dermal filler-related infection. This protocol has been adapted from the Expert Consensus from Merz Aesthetics 2

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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to be making the inflammatory response worse, necessitating the application of higher volumes of • Skin infection related to HA is rare2 but is likely to become more common makeup to cover up an even more erythematous with the overall increase in use of HA as a dermal filler and skin rejuvenation face. It’s important in these cases for the practitioner treatment1 to be aware of this possibility. We agreed in this • If infection occurs, you can follow the advice contained within the Expert case that the patient could wear some makeup for Consensus2 and of that described within this case study an important event she was attending, but was to • If unsure, contact someone with more experience – being part of an wear it for the shortest duration possible and avoid association where you can meet fellow practitioners with different levels of wearing any on the days before and after the event. experience can help By saying simply, ‘you must not wear any makeup’, • Reduce the risk of infection occurring by following an aseptic technique the patient may have had to either miss out on the • Ensure that your patients are aware that they must not apply makeup for at significant event or, ignoring the practitioner’s advice, least 12 hours after receiving a treatment with any HA and limit the use of ended up deeper into the vicious cycle. makeup whilst treating infection As well as adequately dealing with any aestheticinduced complaint, it’s important to take steps to reduce the chances of such an event occurring Day 74: 14 days following antibiotic treatment again in future. In this case, the clinic where the initial treatment was Patient A reported that her makeup, which she was still applying carried out already had an aseptic technique protocol in place. It is occasionally, was no longer stinging. important to realise that even with satisfactory aseptic technique, infection can still occur, but it makes sense to remind all staff of Day 76: 16 days following antibiotic treatment this importance and to inform the patient who has been adversely After 76 days from her initial aesthetic treatment, Patient A reported affected, of what steps have been taken to reduce the chances that the generalised redness (which I had diagnosed as dermatitis of this happening again in the future. Clinics should also consider and not HA-related infection) had reappeared. Again, I recommended handing out aftercare sheets that highlight the need to avoid that the patient to avoid makeup and advised that a GP seeing applying makeup to the face for at least 12 hours post procedure in her without knowing her full history may be tempted to prescribe order to reduce the chances of developing a skin infection.2 We also steroid cream. I explained that this misunderstanding should not be agreed to have some further explanation of this risk added to the allowed to take place as a result of the GP not being aware of the consent form used in the clinic where the treatment took place. true diagnosis. I recommended the avoidance of steroid cream as this might suppress the symptoms of infection, whilst conversely Summary suppressing her immune system from eliminating the infection, until Thankfully, the incidence of HA-related infection is relatively low, but one month after the infection had settled. with many practitioners performing these treatments, it is important that medical professionals are aware of how to utilise correct techniques Day 81: 21 days following initial treatment and know how to treat complications. As with any complication, Patient A reported that all rashes were fully resolved and there were medical aesthetic professionals should be quick to ask for advice no reoccurring rashes thereafter. from a colleague with more experience, should they be unsure as to how to proceed. Referral pathways for HA-related complications are Discussion unfortunately unclear; it is advisable that professionals liaise with either The patient in this case was adamant not to divulge her true history their aesthetic training academy or their local product specialist/sales to the GP due to the stigma of receiving an aesthetic treatment. representative for the product causing concern.

This level of perceived stigma will vary, but needs to be taken Therefore, practitioners should be well informed as to how to manage into account whenever considering how our aesthetic patients this should it occur, and if they are without a prescribing license so will potentially interact with other specialties; particularly if those to prescribe antibiotics, they need to maintain an active professional specialties are unfamiliar with the products that we use in aesthetics. relationship with a prescriber so that access to treatment for such This patient found herself in a vicious cycle, whereby the application complications can be obtained without delay. of makeup to cover the adverse reaction she had suffered appeared

Learning points

As with any complication, medical aesthetic professionals should be quick to ask for advice from a colleague with more experience

Dr Michael Aicken graduated in 2006 from the University of Aberdeen with a degree in medicine and a bachelor of medical sciences. Dr Aicken established Visage Academy and has also been involved in the development of an aesthetic clinic management app called Flourish.

REFERENCES 1. American Society of Plastic Surgeons, ‘2016 National Plastic Surgery Statistics, Cosmetic & Reconstructive Procedure Trends, <https://d2wirczt3b6wjm.cloudfront.net/News/Statistics/2016/2016plastic-surgery-statistics-report.pdf> 2. Christopher Inglefield, Fiona Collins, Marie Duckett, Kate Goldie, et al., Expert Consensus on Complications of Botulinum Toxin and Dermal Filler Treatment, Aesthetic Medicine Expert Group, 2(2014).

3. Samizadeh, S ‘Biofilms’, Aesthetics, 2016, <https://aestheticsjournal.com/cpd/module/biofilms> 4. Joint Formulary Committee, British National Formulary, BMJ Publishing Group Ltd and Royal Pharmaceutical Society, 73(2017).

5. National Eczema Association (US), ‘Controlling Eczema by Moisturizing’, <https://nationaleczema.org/ eczema/treatment/moisturizing/>

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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Superoxide Dismutase Dr Charlene DeHaven provides an overview of the antioxidant superoxide dismutase Superoxide dismutase (SOD) is a powerful antiageing ingredient and one of three intrinsic antioxidants that evolved naturally in the human body to lessen free radical damage.

The processes used to manufacture these substances within the human body are the same metabolic processes used to produce other molecules composing body tissues and active molecules. In addition to SOD, the other molecules in this group of enzymatic antioxidants1 are catalase (CAT) and glutathione peroxidase (GPx). Each of these differs in its molecular structure but all are powerful antioxidants used by the human body to neutralise various forms of free radicals. SOD possesses the property of neutralising the superoxide free radical while CAT and GPx each neutralise other specific free radical types.2 SOD is a powerful antioxidant and animal evidence suggests that boosting levels of SOD may help prevent disease and increase life span.3 Due to such research data, SOD has been a desirable antiageing treatment but, prior to about 20 years ago, could only be given intravenously, due to the molecule being destroyed in the gastrointestinal tract.4 More recent research has suggested that SOD values within the body are higher in physiologically younger and healthier individuals.6 Administration of SOD may also improve diseases related to free radical damage and oxidative stress.5, 7 Around 20 years ago, techniques were first developed that allowed for oral absorption3 but topical absorption remained elusive until recently. Because of formulating innovations, it is now possible to incorporate SOD into cosmeceuticals. Several formulating modifications have been investigated and improve topical absorption – including liposomal encapsulation, complexing with other molecules, or direct injection.8 SOD, CAT and GPx form a group of powerful antioxidants and are unique from other antioxidants that are classed as non-enzymatic in two important ways: 1) They are manufactured inside the body 2) Only very tiny amounts are required for powerful antioxidant effects9

SOD and free radicals In skin, the production of free radicals occurs from solar exposure and energy production inside cells. The majority of the skin’s free radical damage – at least 85% – is from photo-exposure and most of the remainder is from excess free radical production during intracellular energy production. There may be other sources in certain individuals, such as pollution for city dwellers and smoking for tobacco users. Free radicals from all these sources will damage cells and tissues over the course of a lifetime and lead ageing. Visible ageing occurs after physiologic reserve declines and functional capacity diminishes during progressive and cumulative free

Oxidative stress Oxidative stress is a condition where more radical damage occurs within cells than is being neutralised by antioxidants within the body. Our cells are always in a state of oxidative stress because damage always exceeds the body’s protective abilities.22 There are never enough antioxidant mechanisms to fully neutralise free radical generation. With topical SOD, cell products associated with free radical damage and/ or protection can be measured. Improvements occur in these markers of oxidative stress23 – lactic dehydrogenase (LDH), malondialdehyde (MDA), and prostaglandin E2 (PGE2). The formation of PGE2, one of the key inflammatory molecules in the arachidonic acid cascade, is completely prevented. PGE2 has been implicated in all types of pro-inflammatory processes, ranging from sunburn to skin cancer development.24 Topical SOD has been shown to decrease MDA formation and protects cell membranes as well as protecting against fragmentation from free radical damage to Type I Collagen.25 MDA levels are good markers of ongoing free radical damage26 and these are decreased with topical SOD.

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radical damage.10,11,12 Only tiny amounts of enzymes are required in chemical reactions and these compounds are not consumed – in other words they are not ‘used up’ in the process and remain to act again.9 Even after a chemical reaction involving SOD, this antioxidant remains intact and can again participate in further free radical neutralisation.

This contrasts to other important antioxidants, such as vitamin C and vitamin E, which are consumed in the process of neutralising free radicals. Much larger amounts of nonenzymatic antioxidants are required to absorb free radicals.

SOD exists in two forms – SOD1 and SOD2.

SOD2 is found in mitochondria, the energy production factored within all cells.13 Since energy generation is a free radical process, it is not surprising that large numbers of free radicals are formed within mitochondria. SOD1 is found in locations other than mitochondria, such as the cytoplasm of cells.14

The use of SOD in ageing A study with fruit flies (Drosophila melanogaster) by Shen et al. indicated that increasing SOD levels can improve ageing.

Lifespan in fruit flies increased by up to 26% when the substance curcumin, which causes higher SOD levels, was given.15 Caloric restriction is also thought to increase the average human lifespan.

Animal groups, including mammals, have greater gene expression of SOD with caloric restriction.16 Mean animal lifespan has been increased by 10-20% with caloric restriction/energy restriction.17 Caloric restriction is a technique verified to cause increases in average lifespan for many organisms – including rodents, yeasts, fruit flies, worms and primates.18 With caloric restriction, sometimes called energy restriction, calories eaten are decreased by 30-50% while maintaining high nutritional value of foods.19 In other words, very little food is eaten and weight loss is severe, although the nutritional quality of food is kept high. And, even though average lifespan may increase, quality of life is difficult due to constant hunger.

Eating a healthy diet also improves parameters of oxidative stress and can improve health and lifespan. Supplementing the diet of fruit flies with apple polyphenols or curcumin increases their lifespan via upregulation of, in other words ‘turning on’, the genes coding for SOD.20 Blueberry extract, soybean isoflavones, and black rice anthocyanins show similar effects. Many natural antioxidants and functional foods

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Before

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After

Figure 1: Before and one week after treatment with a cosmeceutical containing SOD on the forehead. Images courtesy of INNOVATIVE SKINCARE. Before

After

Figure 2: Before and four weeks after treatment with a cosmecutical containing SOD on the lower face. Images courtesy of INNOVATIVE SKINCARE.

such as apple, blueberry, soybeans, green tea, black tea and black rice possess high antioxidant activity, upregulate genes for SOD production, and increases the amount of SOD produced. Measures to increase SOD have been found to play an important role in delaying ageing.21

The use of SOD in cosmeceuticals SOD can be incorporated into cosmeceuticals and is available in a topical form, which can be absorbed through the skin’s outer barrier.27 Studies on some topical forms of SOD indicate absorption and reduction of free radical damage/oxidative stress.28 SOD aims to protect against lipid peroxidation in delicate skin cell membranes, neutralise the superoxide radical, protect against damaging environmental conditions such as UV exposure,29 guard against pollution, combat photoageing, and reduce UV-induced erythema while enhancing protective effects of suncare products. Topical SOD has been indicated to be useful in the treatment of skin diseases involving inflammation and free radical generation.30 As with all antioxidants, these chemical events occur via the donation of an electron by SOD to the free radical, thus neutralising it.31 Unlike non-enzymatic antioxidants that are destroyed during redox activity, the enzymatic antioxidants like SOD persist longer.32

Conclusion The association of excess free radical damage with solar exposure, environmental stress, pollution, and ageing is well known. Furthermore, ongoing oxidative stress and its associated inflammatory up-regulation is associated with even further downstream tissue injury. The reduction of inflammatory markers and oxidative parameters illustrates the skin benefits of topical SOD.

Disclosure: Dr Charlene DeHaven is the clinical director of the cosmeceutical company iS Clinical, which manufacturers a SOD cosmeceutical.

Dr Charlene DeHaven is a board-certified physician in both internal medicine and emergency medicine, with an emphasis on age management and health maintenance. She currently serves on the lecture faculty for the University of Washington Department of Family Medicine.

REFERENCES 1. Praveen Krishnamurthy and Ashish Wadhwani, Antioxidant Enzymes and Human Health, Antioxidant Enzyme (India: CCBY, 2012 DOI: 10.5772/48109) <https://www.intechopen.com/books/antioxidant-enzyme/antioxidant-enzymes-and-human-health> [accessed 23 August 2017] 2. José M. Matés and Francisca Sánchez-Jiménez, Antioxidant Enzymes and their Implications in Pathophysiologic Processes (Faculty of Sciences, University of Malaga: bioscience, 2000) <https://www.bioscience.org/1999/ v4/af/A432/list.htm> [accessed 23 August 2017] 3. Sampayo JN, Gill MS, Lithgow GJ. Oxidative stress and aging – the use of superoxide dismutase/catalase mimetics to extend lifespan. (London: Biochem Society Transactions, 2003) (Pt6):1305-1307 4. Vouldoukis I et al. Supplementation with Gliadin-combined Plant Superoxide (US: John Wiley & Sons, 2004) pg 12 5. Pelletier KR. The best alternative medicine: superoxide dismutase (SOD): supplements, what works (New York: DrPelletier.com, 2000) <http://www. drpelletier.com/TBAM/excerpts/142-SOD_Supplements.html> [accessed 8 Aug 2017] 6. Miao L, St. Clair DK. Free Radical Biology & Medicine: Regulation of superoxide dismutase genes: implications in diseases. (Netherlands: Elsevier, 2009) 47(4):344-356.

7. Carillon J, Rouanet JM, Cristol JP, Brion R. ‘A potential therapy against oxidative stress related diseases: several routes of administration and proposal of an original mechanism of action.’ Pharmaceutical Research, Superoxide dismutase therapy (US: 2013) (11):2718-2728.

8. Vorauer-Uhl V et al. ‘Topically applied liposome encapsulated superoxide dismutase reduces postburn wound size and edema formation.’ European Journal of Pharmaceutical Sciences. (2001) 14:63-67 9. Leto DF, Jackson TA. ‘Peroxomanganese complexes as an aid to understanding redox-active manganese enzymes.’ Journal of Biological Inorganic Chemistry (2014) (1):1-5.

10. Droge W. ‘Free radicals in the physiological control of cell function’ Physiological Reviews (2002) 82(1):47-95.

11. Valko M et al. ‘Free radicals and antioxidants in normal physiological functions and human disease’ International Journal of Biochemistry and Cell Biolology. (2007) 39(1):44-84.

12. Rashid K, Sinha K, Sil PC. ‘An update on oxidative stress-mediated organ pathophysiology’ Food and Chemistry Toxicology (2013) 62:584-600.

13. Abreu IA, Cabelli DE. ‘Superoxide dismutases – a review of the metal-associated mechanistic variations’ Biochimica et Biophysica Acta (2010) 1804(2):263-274.

14. Nicholls D, Ferguson S. Learn more about SOD1 (Netherlands: Science Direct, Bioenergetics Fourth Edition, 2013) <http://www.sciencedirect.com/ topics/neuroscience/sod1> [accessed 23 August 2017] 15. Shen L, et al. ‘Curcumin-supplemented diets increase superoxide dismutase activity and mean lifespan in Drosophila’ Age. (2013) 35(4):1133-1142.

16. Meydani M et al. ‘The effect of caloric restriction and glycemic load on measures of oxidative stress and antioxidants in humans: results from the CALERIE trial of human caloric restriction.’ Journal of Nutrition, Health and Aging. (2011) 15(6):456-460.

17. Weindruch R. Calorie restriction and aging. (US: Scientific American, 20016) <https://www.scientificamerican.com/article/calorie-restriction-and-aging/> [accessed 23 August 2017] 18. Mercken EM et al. ‘Of mice and men: the benefits of caloric restriction, exercise, and mimetics.’ Ageing Research Reviews (2012) 11(3):390-398.

19. Conniff, R. The Hunger Gains: Extreme Calorie-Restriction Diet Shows Anti-Aging Results, (US: Scientific American, 2017) <https://www.scientificamerican.com/article/the-hunger-gains-extreme-calorie-restriction-diet-shows-anti-aging-results/> [accessed 23 August 2018=7] 20. Peng C, et al. ‘Apple polyphenols extend the mean lifespan of Drosophila melanogaster’ Journal of Agricultural and Food Chemistry (2011) 59(5):2097–2106 21. DeHaven C. ‘Aging gracefully – superoxide dismutase’ Healthy Aging.

(2006) 73-74.

22. Cardenas, E, Davies, K. ‘Mitochondrial free radical generation, oxidative stress, and aging’ Free Radical Biology and Medicine (Netherlands: Elsevier, 2000) 29(3-4)222-230 23. Tappel AL. ‘Vitamin E and Selenium Protection from In Vivo Lipid Peroxidation’ Annals of The New York Academy of Sciences (1980) 335 18-31 24. Dirit R. et al. ‘Studies on the role of reactive oxygen species in mediating lipid peroxide formation in epidermal microsomes of rat skin.’ Journal of Investigative Dermatology (1983) 81:369-375.

25. Petersen SV, Oury TD, Ostergaard L, et al. ‘Extracellular superoxide dismutase (EC-SOD) binds to type I collagen and protects against oxidative fragmentation.’ Journal of Biological Chemistry. (2004) 279(14):13705-13710.

26. Placer Z. et al. ‘Estimation of product of lipid peroxidation (malondialdehyde) in biochemical systems.’ Analytical Biochemistry. (1966) 10:359-364.

27. DeHaven C. Ibid.

28. Rahman, K. ‘Studies on free radicals, antioxidants and co-factors.’ Clinical Interventions of Aging (2007) 2(2) 219–236 29. LeQuere S, Lacan D et al. ‘The role of superoxide dismutase (SOD) in skin disorders.’ Nutrafoods. (2014) 13(1):13-27.

30. Mizushima Y, Hoshi K et al. ‘Topical application of superoxide dismutase cream.’ Drugs Under Experimental and Clinical Research (1991) 17(2):127-131.

31. Lobo V, Patil A et al. ‘Free radicals, antioxidants, and functional foods: impact on human health.’ Pharmacognosy Reviews (2010) 4(8): 118-126.

32. Nimse SB, Pal D. ‘Free radicals, natural antioxidants, and their reaction mechanisms’ RSC Advances (2015) 5:27986-28006.

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Stem Cells Dr Jenna Burton examines the role of topical stem cells in medical aesthetics and compares the potency of topical application versus injectable techniques In the past few decades, stem cells have been harvested to help eradicate arthritic symptoms,1 been used to cure bone marrow deficiencies,2 regenerate breast tissue,3 and have even been used in the cloning of sheep.4 To add to their various and diverse range of uses, they are now been utilised in daily skincare regimes.

Stem cells have a magnitude of purposes. In this article, I shall explore the use of stem cells in skincare and their topical application to identify whether sufficient evidence exists to support their role as antiageing treatments.

What are stem cells?

Stem cells are pluripotent cells – immature cells capable of giving rise to several different cell types – and have the ability to develop into every type of cell within the body. For example, a three-to-five-day-old blastocyst in a mother’s womb initially begins life as a cluster of stem cells. This cluster of cells holds the remarkable ability to produce the skin, heart, lungs and every single cell within the human body; despite the vast diversity in purpose, function and biological anatomy.5 By definition, stem cells have four main characteristics, they:5 • • • •

Mobilise during angiogenesis Differentiate into specialised cell types Proliferate and regenerate Release immune regulators and growth factors

There are two main forms of stem cells. Those which are embryonic in nature; embryonic stem cells, and those which are induced into pluripotency, in other words, reverted back to their more immature state with the capability of giving rise to several different cell types; somatic stem cells.

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Embryonic stem cells The cultivation of human embryonic stem cells was first achieved following research with unused IVF products and aborted foetuses in 1998;6 this was 17 years after a study that obtained stem cells derived from mice.7 In 2006, it was discovered that it was possible to reprogramme specialised adult cells,8 restoring their stem cell quality and hence restoring their ability to develop into any type of cell within the body. This was part of a study conducted by scientists de Wert and Mummery, who converted mice fibroblasts and tail tip fibroblasts into embryonic stem cells using a series of transcription factors.

This was a major breakthrough that removed the ethical debate of utilising embryonic stem cells, which remains controversial in nature secondary to their derivation from early embryos.9 The removal of the ethics debate gives rise to the revolution of much of our medical practice by vastly increasing our access to stem cells and allowing for further research opportunities surrounding their use. A major benefit of all stem cells is their ability to restore and repair, often being referred to as an ‘internal repair system’.5 This occurs both through the production of new tissue cells and through their release of immune regulators and growth factors stimulating nearby cell division, a function that has proved particularly beneficial when injecting stem cells into joints1 and when using them as graft tissue.10 Somatic stem cells There are three main sources of stem cells other than those extracted from embryos: 1. Blood and bone marrow Blood from our circulatory system and bone marrow extracted from the bone can be given back to the same person to replenish their haematopoietic stem cells; this is useful for leukaemia patients.11 The practice has also been used in cosmetic procedures such as platelet rich plasma (PRP) treatments, when useful compounds such as growth factors are injected back in to the skin from plasma taken from brachial veins.12 2. Blood cells from a baby’s umbilical cord Blood can be stored at birth and infused back into the individual at a later stage in the form of red and white blood cells and platelets. This would be done in case the individual needed a transfusion due to ill health at a later stage. Currently this service is only carried out by six NHS hospital facilities.13 The use of umbilical cord blood cells is currently under much investigation for treating brain conditions14 and metabolic complaints such as insulin-dependent diabetes mellitus,15 though this is still at the stage of preliminary research.

3. Adipose tissue Usually taken from the abdomen and buttocks, adipose tissue is most extensively used within orthopaedic and cosmetic procedures. Cosmetic procedures include fat grafting for the face and breast, along with injections into scar tissue to promote healing. As a source of mesenchymal stem cells, adipose tissue can differentiate into many types of cells such as fat, muscle, bone, cartilage, nerve cells and cells found within the epidermal and dermal layers of the skin.16 Mesenchymal stem cells are an example of tissue or ‘adult’ stem cells. They are multipotent, meaning they can produce more than one type of specialised cell within the body.

Adipose cells are most commonly used when administering

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autologous stem cells to a recipient for the purposes of antiageing.

However, many alternatives have been explored, including the application of plant stem cells17 and animal embryonic stem cells.18

Fat grafting Fat grafting, the transfer of fatty tissue containing stem cells, has been around for decades before the discovery of stem cell use.

Initially unaware of the mesenchymal stem cell benefits, fat grafting made an appearance as early as 1893 for use of filling soft tissue defects.19 Not only was this a longer-lasting alternative to collagen and hyaluronic acid, it was also autologous, reducing the risk of immune complications.19 Prior to the use of competent stem cell transfer in cosmetics, orthopaedic surgeons had been utilising its practice with confidence for conditions such as arthritis, tendinopathies and repair of meniscal injury. Although clinical research has remained limited, cell-based techniques involving the injection of mesenchymal stem cells into injured joints have shown improved cartilage repair, repair of meniscal injury and reduced inflammation within arthritic joints, and these are used extensively within every day practice.20 However, additional studies with a lengthier follow up are required to further evaluate these findings in a longer-term environment.

Orthopaedic surgeon, Dr Cecilia Pascual-Garrido, conducted a small study on eight patients with patellar tendinopathies21 – an overuse injury affecting the knee. These patients were injected with autologous mesenchymal cells, and all reported significant improvements in mid-term follow ups at two to five years, a result which reflects the antiageing and repair properties of the stem cells used.

With the added gratification of removing storage of adipose tissue, along with a reported, ‘natural and soft’ appearance and improved appearance of local scar tissue, it was not long before fat grafting was also being used for breast reconstruction in 1895, for women who had undergone surgical mastectomy. Not only did the newly reconstructed breasts display natural, female curves and movement, but the overlying skin tone and scar tissues were much improved. This was later attributed to stem cells within the adipose tissue and prompted exploration for stem cells targeted directly at the skin itself.19

Stem cells and the skin Stem cells were first used for the skin when investigating methods for improved wound healing. It is well known that during the inflammatory phase of wound healing, blood-borne immunocompetent cells invade the wound area, which are suggested to be derived from bone marrow. As severe injury increases the level of stem cells in the blood,22 it is of no surprise that during times of more minor local stress to the skin, stem cells are called upon for the purposes of healing.

This was indicated by Badiavas et al. who inflicted mice with skin wounds. Prior to the wound, green fluorescent protein (GFP) had been ‘tagged’ into the bone marrow of the mice population. They later found GFP-labeled cells in the wound site. Similarly, Fathke et al. reported that distant bone marrow-derived stem cells contributed to the reconstitution of the dermal fibroblast population in cutaneous wounds.24 These findings suggest an important contribution of stem cells within the wound healing process.

23

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differentiating into various tissues with little concern over immune rejection.25 Such tissues include those found in the epidermis, dermis and hypodermis and have received copious amounts of attention regarding their use in the field of dermatology and cosmetics, along with wound healing, diabetic skin ulcers and with burn victims.26 However, bone marrow-derived mesenchymal stem cells do appear to produce higher quantities of collagen and growth factors than those extracted from adipose tissue,27 hence the volume of stem cells required for healing should be considered.

Cosmeceuticals Although stem cells appear to offer antiageing and rejuvenating properties when injected from bone marrow and adipose tissue, is this supported when applied topically? With popularity surrounding the recent release of antiageing ‘stem cell serums’ and cosmeceuticals, does the science support the claims? We have discussed the antiageing repair properties of stem cells, yet many dermatologists claim that when topically applied, their benefits are significantly reduced. Dr Erin Gilbert, assistant professor of dermatology at SUNY Downstate Medical Centre, US, spoke publically at the Cosmetic Surgery Forum in Las Vegas stating that “Stem cells are a natural ingredient, and within topical products, clones of stems are cultivated resulting in a less effective outcome.”28 Gilbert said, “The downside of products containing intact stem cells is that they have no real biologic utility, as they are DOA (dead on arrival) in the absence of a supporting biological environment.

Products containing whole-tissue homogenates are likely to be more effective antiageing treatments because they offer a broader range of beneficial substances, such as autologous fat tissue injections potentially used as fillers for defects of the face, or to fill in deep sunken scars.”

However, she added that stem cell-derived growth factors, that stimulate growth factors and cytokines, are of ‘strong interest’ to researchers in the aesthetics specialty, suggesting that there remains potential for development, despite her current concerns.

Dr Roy G Geronemus, chairman of the board of the New York Stem Cell Foundation – the largest stem cell research programme in the US – agrees with Dr Gilbert. He said, “It makes me sad when I see a dermatologist promoting stem cell products, because we need to be the expert resource on skincare that our patients can trust.”

Despite this, research published in the Journal of Dermatology in 2007 demonstrated the benefit of a novel skin cream containing a

Despite the media boom surrounding stem cell topical treatments, further research is needed on a long-term human study basis

Mesenchymal stem cells derived from more readily available sources such as adipose tissue, along with the less readily available sources such as bone marrow, are capable of self-renewing and

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mixture of growth factors and cytokines, which was obtained through a biotechnology process using cultured human foetal fibroblasts. The skin surface topography was analysed by 3D in vivo by an optical skin imaging device. It was revealed that following two months of application twice-daily, there was a 10-18% reduction in roughness.29 Notwithstanding the dermatological debate, there is little argument that suggestive studies and patient feedback implies satisfaction for the use of stem cell serums and cosmeceuticals, along with the growth factors that they contain. Below are some examples of studies demonstrating positive results:

• The Mibelle AG Biochemistry company, which is a specialist cosmetic company providing research teams for cosmetic advances, carried out clinical tests for stem cell serums. The study, on 20 female participants aged 37-64 years, lasted four weeks.

Depth of wrinkles was measured using the PRIMOS system – an optical device for 3D skin surface display, on the test start and after two and four weeks from there. The research indicated that the wrinkles became ‘shallow’ by 8% after two weeks and by 15% after one month.30 • Drugs of Dermatology (2012) published a study on the effects of applying growth factors contained in stem cell serums. The three month, open-label, single centre study was conducted to determine whether a uniquely derived serum containing barley bioengineered, human-like epidermal growth factor protein could improve visible signs of photodamage and ageing in facial skin. The study was conducted on 29 female patients, aged 39-75 years, with mild to severe, fine and course rhytids, photodamage, and pigmentation. Subjects applied the serum protocol twice-daily for three months, in addition to the use of a basic sunscreen and facial cleanser. In-person clinical evaluations and subject self-assessment questionnaires were used. Clinical evaluations exhibited statistically significant improvement in the appearance of fine lines and rhytids, skin texture, pore size, and various dyschromatic conditions apparent within the first month of use, and continuing improvement trends for the duration of the study.31 • Regenica gel, which contains growth factors, was tested for its efficacy in healing skin after laser resurfacing. The split-face clinical evaluation included 42 subjects undergoing combination ablative and non-ablative laser procedures. Histopathology indicated reduced inflammation in biopsies from treated skin compared to untreated skin.32

Conclusion With their ability for harvesting, small concerns over immune reactions and the potential for growing incredibly useful by-products including growth factors, it seems likely that the use of stem cells will continue to expand and form the foundation of much future research, both within cosmetics and within mainstream medicine. It has been indicated through clinical studies that stem cells are beneficial for the skin, within wound healing, skin grafting and when injecting blood and adipose tissue beneath the skin’s surface. They assist with scar healing, and can promote suppleness and improved pigmentation to the skin surface, with results outlasting collagen and hyaluronic acid substitutes.16,18,19 As well as this, they are natural. However, it appears that despite the media boom surrounding stem cell topical treatments, further research is needed on a long-term human study basis before we can report their use with confidence.

Aesthetics Dr Jenna Burton is an aesthetic practitioner heavily involved in population health promotion, focusing particularly on the promotion of chronic eating disorder management. She has obtained a diploma from the American Academy of Aesthetic Medicine and is currently working towards her American Medical Board Specialist Status. Dr Burton works between the UK and Dubai.

REFERENCES 1. Jo CH, Lee YG, Shin WH et al. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells. (2014) May;32(5):1254-66.

2. Service, National Health. Stem Cell and Bone Marrow Transplant, (2015) <http://www.nhs.uk/ Conditions/Bone-marrow-transplant/Pages/How-is-it-performed.aspx> 3. Lohsiriwat, Tanasit Techanukulco and Visnu, Stem cell and tissue engineering in breast reconstruction. Gland Surgery (2014) Feb; 3(1): 55–61.

4. Coghlan, Andy, New Scientist. Human stem cells made using Dolly cloning technique, (2013) <https://www.newscientist.com/article/mg21829174-200-human-stem-cells-made-using-dollycloning-technique/> 5. Bethesda, NIH Stem Cell Information Home Page, In Stem Cell Information, National Institutes of Health, U.S. Department of Health and Human Services, (2016) Available at <stemcells.nih.gov/info/ basics/1.htm> 6. Cohen, Philip. Hold the Champagne. New Scientist, (1998) <https://www.newscientist.com/article/ mg16021600-900-hold-the-champagne/> 7. Gail R. Martin, Isolation of a pluripotent cell line from early mouse embryos cultured in medium conditioned by teratocarcinoma stem cells, Development Biology (1981) <http://svn.donarmstrong. com/don/trunk/projects/research/stem_cells/papers/pluripotent_cell_line_from_mouse_ blastocyst_martin_pnas_78_7634_1981_pmid_6950406.pdf> 8. Jong Soo Kim, Hyun Woo Choi, Sol Choi, and Jeong Tae Do. Reprogrammed Pluripotent Stem Cells from Somatic Cells. s.l.:International Journal of Stem Cells. Jun; 4(1): 1–8, (2010) 9. Human embryonic stem cells: research, ethics and policy . Guido de Wert, Christine Mummery.

Human Reproduction (2003) 18 (4): 672-682.

10. D. T. J. Gampper, Facial Fat Grafting, (2017) <http://emedicine.medscape.com/article/1283020overview#a8> 11. American Cancer Society. Treating Acute Myeloid Leukaemia. www.Cancer.org. (2016) <https:// www.cancer.org/cancer/acute-myeloid-leukemia/treating/bone-marrow-stem-cell-transplant.html> 12. Maria-Angeliki Gkini, Alexandros-Efstratios Kouskoukis, Gregory Tripsianis et al. Study of PlateletRich Plasma Injections in the Treatment of Androgenetic Alopecia Through an One-Year Period. s.l.

J Cutan Aesthet Surg. 2014 Oct-Dec; 7(4): 213–219.

13. Baby Centre, Can I Store My Babies Umbilical Blood for Medical Purposes? Dr Morag Martindale, March 2015, Accessed July 2017 14. Amy P. Murtha, Ronald N. Goldberg, Chad A. Grotegut, et al. Feasibility of Autologous Cord Blood Cells for Infants with Hypoxic-Ischemic Encephalopathy. (2014) May; 164(5): 973–979.e1.

15. CryoCell, Treating Diabetes with Stem Cells. CryoCell International, <https://www.cryo-cell.com/ cord-blood/diabetes> 16. Lindroos B, Suuronen R, Miettinen S, The potential of adipose stem cells in regenerative medicine, Stem Cell Rev. 2011 Jun;7(2):269-91. doi: 10.1007/s12015-010-9193-7.

17. Sanz MT, Campos C, Milani M et al. Biorevitalizing effect of a novel facial serum containing apple stem cell extract, pro-collagen lipopeptide, creatine, and urea on skin aging signs. J Cosmet Dermatol, (2016) Mar;15(1):24-30. doi: 10.1111/jocd.12173. Epub 2015 Oct 1 18. Stem Cell Beauty Innovations, Science and Studies, (2017) <https://www.scbistore.com/sciencestudies/> 19. Gampper, Thomas J, Facial Fat Grafting, Medscape (2017) <http://emedicine.medscape.com/ article/1283020-overview> 20. Bryan M. Saltzman, Benjamin D. Kuhns, MMS, Alexander E. Weber, et al. Vols. Stem Cells in Orthopedics: A Comprehensive Guide for the General Orthopedist. Am J Orthop. (2016) July;45(5):280-288, 326.

21. Cecilia Pascual-Garrido, A. Rolón, and A. Makino, Treatment of Chronic Patellar Tendinopathy with Autologous Bone Marrow Stem Cells: A 5-Year-Followup. Vol. Stem Cells Int. 2012; 2012: 953510.

22. M. P. a. F. B. Ming Chen, Stem Cells for Skin Tissue Engineering and Wound Healing, Crit Rev Biomed Eng. 2009; 37(4-5): 399–421.

23. Badiavas EV, Falanga V, Treatment of chronic wounds with bone marrow-derived cells, Arch Dermatol. (2003) Apr;139(4):510–6.

24. Fathke C, Wilson L, Hutter J, Kapoor V et al. Contribution of bone marrow-derived cells to skin: collagen deposition and wound repair. <https://www.ncbi.nlm.nih.gov/pubmed/15342945> 25. Te-Chao Fang, Malcolm R Alison, Nicholas A Wright, & Richard Poulsom, Adult stem cell plasticity: will engineered tissues be rejected? Int J Exp Pathol. (2004) Jun; 85(3): 115–124.

26. Hisham Daouk, Bassel El Baba, Sana Chams et al. The Use of Stem Cells in Burn Wound Healing: A Review, Volume 2015 (2015), Article ID 684084, BioMed Research International.

27. M. P. a. F. B. Ming Chen, Stem Cells for Skin Tissue Engineering and Wound Healing, Crit Rev Biomed Eng. 2009; 37(4-5): 399–421.

28. Stem cell based cosmeceuticals popular but lack sufficient human studies. Dermatology Times.

(2013) <http://dermatologytimes.modernmedicine.com/dermatology-times/news/tags/dermatology/ data-insufficiency-stem-cell-based-cosmeceuticals-gain-popul> 29. Gold MH, Goldman MP, Biron J. Human growth factor and cytokine skin cream for facial skin rejuvenation as assessed by 3D in vivo optical skin imaging, J Drugs Dermatol. (2007) Oct;6(10):1018-23.

30. Morus, Marthyna, Plant Stem Cells as Innovation in Cosmetics, s.l. : Acta Poloniae Pharmaceutica Drug Research, Vol. 71 No. 5 pp. 701-707, (2014) 31. Jonathan M. Schouest BS, Teresa K. Luu MD, and Ronald L. Moy MD, Improved Texture and Appearance of Human Facial Skin After Daily Topical Application of Barley Produced, Synthetic, Human-like Epidermal Growth Factor (EGF) Serum. s.l. Drugs of Dermatology, Vols. May (2012), Volume 11, Issue 5, 613.

32. M. P. Zimber, J. N. Mansbridge , M. Taylor, T. Stockton, Human Cell-Conditioned Media Produced Under Embryonic-Like Conditions Result in Improved Healing Time After Laser Resurfacing. Aesth Plast Surg : <DOI 10.1007/s00266-011-9787-8>

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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PDO Thread Outcomes In the first of a two-part article, Dr lrfan Mian explains what practitioners should be aware of when placing PDO cog threads to ensure patient safety and positive results Polydioxanone (PDO) as a material for lifting tissue is now recognised as a relatively safe product with transient minor side effects, provided correct operative techniques are adopted. This is supported by a 24-month retrospective study of PDO threadlift outcomes by Suh et al. that took place in 2015.1 The outcome of any threadlift procedure is dependent on patient selection, using the typical exclusion criteria that would also be used for the placement of dermal fillers and botulinum toxins. Therefore, it will not be listed in this article. There are, however, some additional criteria specifically related to the art and science of PDO thread placement. In practical terms, PDO threads can be divided into two main types: cog threads and non-cog threads. Cog threads are barbed and are available as unidirectional, multidirectional, 3D or 4D barbs.2 Cog thread placement requires a degree of clinical acumen, treatment planning, manual dexterity and a good aseptic technique.

I shall highlight the important points to be aware of when conducting a cog PDO thread treatment, which are paramount in achieving consistently good clinical outcomes.

Although the focus of this article is on cog threads, there are also non-cog PDO threads which are available as monos, twisted monos, tight and normal pitch screws, multifilament and cavern threads. They come in a variety of sizes and may be sharp or blunt ended. These types of PDO threads tend to be more ‘forgiving’ as they hydrolyse after four to eight weeks, compared to nine to ten months for cogs.

The exception is caverns, which are thicker and last much longer, between four to five months.

Cog threads Cog placement to rejuvenate the face and submental area can be a challenge. I believe this type of procedure is probably not suitable for a ‘sole practitioner’ to carry out as, in my experience, clinical outcomes are greatly improved if there are suitably trained and qualified staff present to assist the operating practitioner. My experience over the last few years has highlighted the need for a team approach during the placement of PDO threads. I have Before

During

Aesthetics

observed that the lack of additional staff has contributed to the failure or poor clinical outcomes of some of these procedures. It is difficult for a sole practitioner to simultaneously do a great deal of multitasking to achieve good thread placement.

The practitioner is required to place a number of cogs, in some cases ten or more, and hold them in place, tense them and adjust the tension as required in order to achieve symmetry, which necessitates looking at the patient’s face front-on. At the same time, the threads must be held in position, twisted in opposite directions, tension checked again, followed by the placement of additional threads to achieve ‘thread locking’. In some cases, the practitioner is supported by two other members of staff, thereby performing a six-handed threadlift.

Finally, whilst all is held in place, the threads have to be ‘deep tissue’ cut. This technique involves placing the thread between the blades of the scissors and then pushing the skin down with the scissors before cutting, which ensures the skin bounces back and completely covers the thread. If the thread is left too superficial, there is risk of infection and poor healing, which, at worst, could result in a granuloma.3 Anaesthesia Cog placement is not a pain-free procedure and local anaesthesia for the face, neck and body can be used to achieve patient comfort, which may include facial and body infiltration or block anaesthesia.

In addition, the practitioner may choose to employ a method I created, the Mian’s Alternative Snooker Hold (MASH) technique, which allows for ‘on demand’ anaesthesia at the appropriate site at the request of the patient. This is done by inserting the PDO thread into a 2ml syringe, which has been prefilled with local anaesthetic without a vasoconstrictor.4 Some practitioners use and recommend intravenous conscious sedation using titrated midazolam, supplemented with local block or infiltrative anaesthesia. Cosmetic surgeon Dr Rakesh Kalra advocates in his study ‘Use of barbed threads in facial rejuvenation’ in the Indian Journal of Plastic Surgery, in 2008, that this is the best way to perform cog thread insertion.5 I believe this is likely to be because, apart from achieving greater patient comfort, there is subsequent patient amnesia which improves the patient experience as they are unaware of the pain.5 In my experience, this results in greater patient retention and a higher rate of uptake of re-treatment. Intravenous conscious sedation must be carried out in appropriately-equipped premises for resuscitation and recovery, with staff who are trained and experienced in resuscitation and patient recovery procedures.

The practitioner can use a variety of infiltration anaesthetic sites and there are a number of vasoconstrictors available based on personal preference. The patient’s medical history, however, may necessitate a particular agent. An example would be a patient with a history of cardiovascular disease, such as exertional angina, which is under control with medication. In this case, it would be unwise to use Immediately after

Eight months post treatment

Figure 1: Patient A before PDO threadlift treatment, during, immediately after and eight months post treatment

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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aestheticsjournal.com Before

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After

Figure 2: Patient B before and after PDO threadlift in the maxillary and mandibular

adrenaline as a vasoconstrictor as it may, by adding to endogenous adrenaline, cause syncope or even a cardiac-related emergency.

Other vasoconstrictors such as felypressin, which are not cardiac stimulants, should be used instead.

Care should always be taken when using adrenaline-based vasoconstrictor local anaesthetic, as I have experienced cases where a cardiac event has occurred even though the patient’s medical history was stated as clear. It was subsequently found that these patients had subclinical asymptomatic cardiac disease.

Iatrogenic infection Cog placement can cause significant transient commensal and pathogenic bacteria to enter the tissues and, more importantly, enter the circulatory or lymphatic systems, which will carry the infection away from the operating site. These ‘infection emboli’ may then lodge anywhere in the body. This may include the tricuspid or mitral valve of the heart if they have sustained previous damage by, for example, rheumatic fever.6 In most cases the patient would state they have had rheumatic fever, which usually presents as a childhood fever, in their medical history. Many patients may be aware or have been informed that they have a cardiac murmur or a systolic or diastolic thrill as a result. These patients would be given antibiotics pre-procedure.

In other cases, the patient may be unaware that they had rheumatic fever as they have suffered no clinical side effects. They may have assumed that they simply had a ‘childhood fever’. These patients may be at risk of streptococcal bacterial colonisation of the cardiac valves, which subsequently may release bacterial emboli, resulting in the symptoms of subacute bacterial endocarditis (SBE), which could have a debilitating or even fatal outcome.6 For this reason, prophylactic antibiotic cover must be given. This can be either as a course prior to the appointment for cog thread insertion or as an oral bolus one hour before treatment, followed by an oral course six hours post procedure, for up to five days. The important Before

After

Aesthetics

point is that at the time of the threadlift procedure, there should be adequate therapeutic levels of the appropriate antibiotic in the tissues of the body.

Cog failure One of the main causes of an unsuccessful cog treatment is the placement of the cogs in the wrong tissue plane. The correct plane for insertion is the superficial musculo-aponeurotic system (SMAS) and the technique for placement has been described and well documented.7 A new and relatively easy method to find the correct plane is by the use of a 2ml syringe that I have created and written about in a previous article entitled ‘PDO threadlifting’, published in the Aesthetics journal in 2016.4 It is important for practitioners to be familiar with the anatomy of the SMAS, especially its centrifugal arrangement in the face and neck. The SMAS is not uniformly found over the face and neck and in some areas, such as the forehead, lower face and neck, it combines the facial muscles, especially the ‘frontal’ part of the occipitofrontalis, and the mandibular portion of the platysma muscle.8 Some PDO cogs are available with a needle-type end which certain practitioners find easier to insert as an entry point does not have to be created. Needle-type PDO cogs, however, have a far greater propensity to damage and cut vessels and nerves. This can cause post-treatment numbness or paralysis of the affected mimic muscles.

The facial artery is also at risk of puncture with these types of threads, especially at its most superficial point near the oral commissure, also known as Manson’s point. This point is a surgical landmark near the corners of the mouth which identifies the facial artery with 100% accuracy.9

Summary Hard evidence-based research regarding techniques, effects, results and long-term outcomes is limited for all types of thread techniques due to it still being a relatively new procedure.

Therefore, to advance our knowledge, an exchange of ideas and case studies between threadlift practitioners may result in better outcomes. It is this empirical experience which is important in the advancement and understanding of PDO thread therapy.

Read part two of this article in the next issue of Aesthetics.

Dr Irfan Mian has dual qualification as a doctor and dental surgeon and is medical director of Chinbrook Medical Cosmetic Centre. He has a special interest in all types of threadlifts for the face, neck and body and is a board member of The Association of PDO Threads UK. Dr Mian is a registered and insured trainer in aesthetic medicine.

REFERENCES 1. Suh DH,Jang HW,Lee SJ,Lee WS. ‘Outcomes of polydioxanone knotless threadlifting for facial rejuvenation’ Dermatological Surgery 6 (2015) 2. Dr Irina Lopandina, PDO Lifting Threads; New Approach to Skin Rejuvenation (2014), Reachback ltd; UK 3. Aitken, R. J., Anderson, E. D., Goldstraw, S. & Chetty, U. Subcuticular skin closure following minor breast biopsy: Prolene is superior to polydioxanone (PDS). J. R. Coll. Surg. Edinb. 34, 128–9 (1989).

4. Mian I, ‘PDO threadlifting’ Aesthetics Journ Vol 3/issue 5 April (2015) 5. Rakesh Kalra. ‘Use of barbed threads in facial rejuvenation’ Indian J Plastic Surgery 2008 Oct;(suppl)l S93-S100 6. Jeffrey D Greenberg, Andrew Bonwit and Mark G. Roddy, Subacute Bacterial Endocarditis Prophylaxis: A Succinct Review for Pediatric Emergency Physicians and Nurses, ResearchGate, (2005) <https://www.researchgate.net/publication/222808900_Subacute_Bacterial_Endocarditis_ Prophylaxis_A_Succinct_Review_for_Pediatric_Emergency_Physicians_and_Nurses> 7. Healios, PDO thread lift, (2016) <http://www.healioswoundsolutions.com/dermatology/pdo-threadlift-tips-tricks-part-1/> 8. Broughton M Fyfe GM ‘The Superficial Musculoaponeurotic System of the Face: A Model explored.

Anat Research Inter Vol (2013) Article ID 794682 9. Calva D,Chopra KK,De La Cruz C,Rodriguez RD Christy MR ‘Manson’s Point:A facial Landmark to Identify the Facial Artery’ J Plast Recostr Aesthetic Surg Sept 2015,Vol 68 (9); 1221-1227

Figure 3: Patient C before and after PDO thread treatment in the submental area

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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Aesthetics | September 2017

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From order to door with Med-fx: Your partner in facial aesthetics PROBLEM: It’s 5.35pm and your last patient of the day has just left. It’s been a busy week, you’ve been run off your feet and it’s the first chance you’ve had to review your stock levels. It’s only now that you realise you’re running low on your most popular line of cosmeceuticals, you could really do with a top up of toxins and fillers and you’re almost out of some practice essentials, including those gloves you like.

SOLUTION: If you find yourself in this position you’re not alone.

At Med-fx we speak to clinicians everyday who find themselves struggling to manage stock, or who forgot one important item from their order and those who need a last-minute delivery.

We’ve been working with facial aesthetic practitioners for over a decade so we understand the challenges you face, which is why Med-fx customers can call our customer support team and take advantage of a 6pm cut off time for next day delivery and a six-day cold chain delivery service.

Our customer service team consists of industry experts. In fact, we only employ experienced and knowledgeable people to support our customers. Each day our team receives upwards of 150 calls and, because we know time is precious to our customers, 99% of these are answered in under 10 seconds.

Contact centre manager, Sally Macklin, says: “Calls received at the end of the day tend to be last-minute orders. Clinicians often call us panicking. But that’s why we’re here, to help make their lives easier and it’s great to take away the customer’s stress and provide a solution to their problem.”

PROBLEM: You’re new to facial aesthetics or expanding your treatment offering. You’re confident in offering the new treatments to your patients, but you want to feel reassured that if you needed pharmaceutical advice and product support it will be available to you. But where do you turn?

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opinion from a pharmacist. Our role isn’t just about dispensing product to our customers, it’s also about being supportive and providing access to expertise when they need it.”

The pharmacy, which dispenses more than 70,000 prescription items every year, also helps run the Med-fx eScript service.

Umash adds: “Our customers love the eScript service. It has simplified the process of placing prescription orders. Now registered customers don’t have to write out a prescription they can simply use the online based eScript service.”

As well as being the best in the business our pharmacists are also pretty speedy. Orders can be registered, dispensed and ready for dispatch in 40 minutes.

PROBLEM: You’ve been let down in the past with your facial aesthetics supply orders. They’ve arrived late or incomplete, temperature controlled items have restricted delivery times and it all feels like a lot of hard work, especially if you’re reliant upon multiple suppliers to deliver the products your clinic needs to run smoothly day-in-day-out.

SOLUTION: Med-fx has a 99.4% order accuracy rate. That means when a customer orders with us they receive their whole order, when their business needs it. Each Med-fx order is processed through our 95,422 sq. ft. purpose-built warehouse before making the final journey to our customers.

Unsurprisingly the warehouse is an exceptionally busy area. It’s full of the latest technology to ensure precision and efficiency.

And it’s a part of the Med-fx order journey we’re investing in. Customers told us they wanted temperature controlled products on a Monday morning with a last-minute Friday order.

Med-fx, therefore developed special temperature controlled packaging to enable weekend orders to arrive safely, ready to use and at a time convenient for our customers. What’s more, Med-fx offers a one-stop-shop for customers with its 1,200 facial aesthetic and cosmeceutical products and 27,000 medical consumables.

David LeGood, Director of Operations says: “Every parcel is as important to us as it is to our customers. Each order placed with Med-fx is delivered quickly, professionally and with care. That’s why our customers order with us time-after-time.”

To find out how Med-fx can help your business visit www.med-fx.co.uk, call 0800 783 06 05 or contact one of our experienced sales force team.

SOLUTION: In addition to our in-house pharmacy, Med-fx has a team of pharmacists on hand with more than 50 years of experience who dispense orders and support our customers.

Umash Patel, Pharmacy Manager says: “We talk to our customers a lot, I estimate that we advise over 100 different customers a week. Most of the calls are from clinicians asking detailed questions about how to use a new treatment or product. Some just want to be reassured, or ask for a second

Kelly Tobin

Lorraine McLoughlin

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Aesthetics | September 2017

Med-fx Facial Aesthetics Manager: South

Zara Vickers

Med-fx Dental (Facial Aesthetics) Manager: UK

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TREATING UNWANTED FACIAL HAIR: Optimising outcomes in ‘problem patients’ With the advent of laser hair removal and intense pulsed light (IPL), unwanted facial hair has become less of a problem for many women. While these treatments are not permanent, they provide excellent results for many women.1 There is a small group of women however, for whom even laser therapy does not provide satisfactory results – ‘problem patients’.1,2 Who are ‘problem patients’?

Women with white or fair hair.2,3 Equally, some women with darker skin who may be at risk of pseudofolliculitis barbae and post-inflammatory hyperpigmentation following laser treatment.1 Although laser technology has advanced, and the ability to treat patients with Fitzpatrick type IV-VI skin has improved, for most of these ‘problem patients’ laser therapy alone is not enough to provide acceptable results.1 How do we help these ‘problem patients’?

It is important to look for adjunctive treatments to help achieve the best possible results in these women. VANIQA® (eflornithine 11.5% cream), the only prescribed, nonhormonal topical treatment licensed for facial hirsutism in women, may present a particularly useful adjunct to laser therapy as it works in a complementary way to laser, significantly slowing hair re-growth between laser treatments.3,6 VANIQA® works by inhibiting the enzyme ornithine decarboxylase, preventing synthesis of polyamines, which are essential for hair growth and can be used in women with all skin and hair types.2-6 VANIQA® reduces hair growth for as long as it is used continuously, with results evident from as early as 8 weeks.7,8 VANIQA® is proven to have a synergistic effect in combination with laser therapy – finally providing a solution for even the most difficult-to-treat patients.3,6 For more details on VANIQA® and how it can help your patients, please visit: vaniqa.co.uk VANIQA® is a prescription only medicine available from Wigmore Medical: pharmacy@wigmoremedical.com T: 020 7491 0111 and Healthxchange Pharmacy: orders@healthxchange.com T: 01481 736837 REFERENCES: 1. Callender V, et al. J Am Acad Dermatol 2005; 52(3): Suppl P209.

2. Shapiro J, Lui H. Skin Therapy Letter 2005/6; 10: 1-4.

3. Hamzavi I, et al. J Am Acad Dermatol 2007; 57: 54-9.

4. Balfour J, McClellan K. Am J Clin Dermatol 2001; 2: 197-201.

5. Malhotra B, et al. J Clin Pharmacol 2001; 41: 972-8.

6. Smith S, et al. Dermatol Surg 2006; 32: 1237-43.

7. VANIQA SPC. Available at: www.medicines.org.uk/emc/medicine/21243. Accessed Jun 2017 8. Schrode K, et al. Poster presented at 58th Annual Meeting of the Academy of Dermatology 2000, 10-15 March, San Francisco; USA, Poster 291.

For Healthcare Professionals only.

For prescribing information, please see facing page.

58

Aesthetics | September 2017

Date of preparation: August 2017 UKEFL3734c

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A summary of the latest clinical studies Title: The Classification and Prognosis of Periocular Complications

Related to Blindness following Cosmetic Filler Injection Authors: Myung Y, Yim S, Jeong JH, et al.

Published: Plastic & Reconstructive Surgery, July 2017 Keywords: Hyaluronic acid, dermal filler, blindness Abstract: Common side effects during hyaluronic acid filler injections are typically mild and reversible, but several reports of blindness have received attention. The present study focused on orbital symptoms combined with blindness, aiming to classify affected patients and predict their disease course and prognosis. From September of 2012 to August of 2015, nine patients with vision loss after filler injection were retrospectively reviewed. Ptosis, ophthalmoplegia, and enophthalmos were recorded over a 6-month follow-up, and patients were classified into four types according to periocular symptom manifestation. Two patients were categorized as type I (blindness without ptosis or ophthalmoplegia), two patients as type II (blindness and ptosis without ophthalmoplegia), two patients as type III (blindness and ophthalmoplegia without ptosis), and three patients as type IV (blindness with ptosis and ophthalmoplegia). The present study includes previously unpublished information about orbital symptom manifestations and prognosis combined with blindness caused by retinal artery occlusion after cosmetic filler injection.

Title: Precise Role of Dermal Fibroblasts on Melanocyte Pigmentation Authors: Wang Y, Viennet C, Robin S, et al.

Published: Journal of Dermatological Science, July 2017 Keywords: Fibroblasts, melanin, pigmentation Abstract: Dermal fibroblasts are traditionally recognized as

synthesizing, remodeling and depositing collagen and extracellular matrix, the structural framework for tissues, helping to bring thickness and firmness to the skin. However, the role of fibroblasts on skin pigmentation arouses concern recently. This review highlights the importance of fibroblast-derived melanogenic paracrine mediators in the regulation of melanocyte activities. Fibroblasts act on melanocytes directly and indirectly through neighboring cells by secreting a large number of cytokines (SCF), proteins (DKK1, sFRP, Sema7a, CCN, FAP-α) and growth factors (KGF, HGF, bFGF, NT-3, NRG-1, TGF-β) which bind to receptors and modulate intracellular signaling cascades (MAPK/ERK, cAMP/PKA, Wnt/β-catenin,

PRESCRIBING INFORMATION (Please consult the Summary of Product Characteristics (SmPC) before prescribing.)

Vaniqa 11.5% Cream eflornithine Active Ingredient: eflornithine 11.5% (as hydrochloride monohydrate).

Indication: Treatment of facial hirsutism in women. Dosage and Administration: Should be applied to the affected area twice daily, at least eight hours apart. Application should be limited to the face and under the chin. Maximal applied doses used safely in clinical trials were up to 30 grams per month. Improvement in the condition may be noticed within eight weeks and continued treatment may result in further improvement and is necessary to maintain beneficial effects.

Discontinue if no beneficial effects are noticed within four months of commencing therapy. Patients may need to continue to use hair removal methods (e.g. shaving or plucking) in conjunction with Vaniqa. Application of Vaniqa should be no sooner than 5 minutes after use of other hair removal method, as increased stinging or burning may occur. A thin layer of the cream should be applied to clean and dry affected areas. The cream should be rubbed in thoroughly. The medicinal product should be applied such that no visual residual product remains on the treated areas after rub-in. Hands should be washed after applying this medicinal product. For maximal efficacy, the treated area should not be cleansed within four hours of application. Cosmetics (including sunscreens) can be applied over the treated areas, but no sooner than five minutes after application. The condition should improve within eight weeks of starting treatment. Paediatric populations: The safety and efficacy of Vaniqa in children 0-18 years has not been established. Hepatic /renal impairment: caution should be used when prescribing Vaniqa. Consult SmPC for further information. Contraindications, Warnings, etc: Contraindications: Hypersensitivity to eflornithine or to any of the excipients. Warnings & Precautions: Excessive hair growth can result from serious underlying disorders (e.g. polycystic ovary syndrome, androgen secreting neoplasm) or certain active substances (e.g. cyclosporin, glucocorticoids, minoxidil, phenobarbitone, phenytoin, combined oestrogen-androgen hormone replacement therapy). These factors should be considered in the overall medical treatment of patients who might be prescribed Vaniqa. For cutaneous use only. Contact with eyes or mucous membranes (e.g. nose or mouth) should

PI3K/Akt) related to melanocyte functions. These factors influence the growth, the pigmentation of melanocytes via the expression of melaninproducing enzymes and melanosome transfer, as well as their dendricity, mobility and adhesive properties. Thus, fibroblasts are implicated in both skin physiological and pathological pigmentation. In order to investigate their contribution, various in vitro models have been developed, based on cellular senescence. UV exposure, a major factor implicated in pigmentary disorders, may affect the secretory crosstalk between dermal and epithelial cells. Therefore, identification of the interactions between fibroblasts and melanocytes could provide novel insights not only for the development of melanogenic agents in the clinical and cosmetic fields, but also for a better understanding of the melanocyte biology and melanogenesis regulation.

Title: Microneedling: Where do we stand now? A systematic review of the literature

Authors: Ramaut L, Hoeksema H, Pirayesh A, et al.

Published: Journal of Plastic, Reconstructive and Aesthetic Surgery,

June 2017

Keywords: Microneedling, scars, skin rejuvenation Abstract: Patients who suffer from scars or wrinkles have several

therapeutic options to improve the appearance of their skin. The available treatment modalities that provide desirable results are often overtly invasive and entail a risk of undesirable adverse effects.

Microneedling was investigated in experimental settings for its effects on atrophic acne scars, skin rejuvenation, hypertrophic scars, keloids, striae distensae, androgenetic alopecia, melasma and acne vulgaris. Several clinical trials used randomisation and single-blindation to strengthen the validity of the study outcome. Microneedling showed noteworthy results when used on its own and when combined with topical products or radiofrequency. When compared with other treatments, it showed similar results but was preferred due to minimal side effects and shorter downtime. This systematic review positions microneedling as a safe and effective therapeutic option for the treatment of scars and wrinkles.

The current literature does show some methodological shortcomings, and further research is required to truly establish microneedling as an evidence-based therapeutic option for treating scars, wrinkles and other skin conditions.

be avoided. Transient stinging may occur if applied to abraded or broken skin. If skin irritation or intolerance develops, the frequency of application should be reduced temporarily to once a day. If irritation continues, treatment should be discontinued and the physician consulted. Contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) as well as methyl parahydroxybenzoate and propylparahydroxy-benzoate which may cause allergic reactions (possibly delayed).

Interactions: No interaction studies have been performed.

Pregnancy and lactation: Women should not use Vaniqa whilst pregnant or breastfeeding.

Ability to drive and use machines: Vaniqa has no or negligible effects on the ability to drive and use machines.

Adverse Effects: These are ranked under heading of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).

Very common: acne. Common: pseudofolliculitis barbae, alopecia, stinging skin, burning skin, dry skin, pruritus, erythema, tingling skin, irritated skin, rash, folliculitis. Uncommon: bleeding skin, furunculosis. Rare: rosacea, skin neoplasm, skin cysts, vesiculobullous rash. Consult SmPC in relation to other adverse effects. Legal Category: POM Marketing Authorisation Number(s): EU/1/01/173/003 NHS Cost: (excluding VAT) Tube containing 60g - £56.87 Marketing Authorisation Holder: Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, Spain.

Further information is available from: Almirall Limited, Harman House, 1 George Street, Uxbridge, Middlesex, UB8 1QQ, UK. Tel: 0800 0087 399. Email: almirall@professionalinformation.co.uk Date of revision: 05/2017 Item code: UKEFL3336a(1) 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 Almirall Ltd.

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Mitigating Risks to Mitigate Costs

arising, action taken in response to these problems and clear rationale/evidence for the proposed care plan, including any identified follow-up action, should also be specified.

• Records completed at the time of the consultation. If done shortly after, then they should be recorded showing the date and time Medical malpractice and risk specialist Martin of the record being created, and the the actual event/consultation.

Swann provides tips for mitigating your • All records should be stored securely, for insurance risks and reducing the chance of a example, they should be encrypted when at rest in your network, and adequately backed up so successful claim being brought against you they can be restored easily, in the event of a loss The number one question I am asked as an insurance provider of data. Storage of records and the responsibility for the security when talking to a prospective new client is ‘how much?’ Given that and safeguarding of the data you are holding will increase the premium levied for your insurance is reflective of your perceived significantly with the introduction of GDPR.2,4 risk to your insurer, reducing your risk could reduce the rates used to • Legible text, which is explained in more detail below. calculate your premium. In this article, I will provide my best tips for not only improving the risk your practice represents to insurers, but also Insurers are starting to pay more attention to how data and patient for reducing the chance of a successful claim being brought against records are stored and how a practice would deal with a breach as you and your clinic. part of their underwriting process, which is understandable given the increased duty of care that the new regulations represent for Risk assessment practitioners.2 Those practices with good procedures and processes I have found that, ever increasingly, the purchase of insurance is for data collation, storage and security are considered a better risk regarded as a ‘commodity purchase’, with the cost of cover being a from a GDPR perspective and rates will be reflective of this.3 large factor in the decision of which provider to partner with. If you think of insurance in the same way a bookmaker would consider odds provided for horse racing, those with the best chance of winning (not Record keeping do’s and don’ts having a claim) have the lowest odds (cheapest rates).

• Do ensure that all consultation forms are fully completed If you are perceived to be a greater risk due to poor risk management, and where sections are not relevant, record as such. the processes and procedures you adopt, or just having a poor Leaving sections blank could create ambiguity and call claims history, it will have an impact on the rate applied by an insurer.1 into question during litigation as to whether or not those Sound risk management and risk mitigation should levy the most matters left blank were discussed/considered. cost effective risk transfer (insurance) and reduce the chances of a • Don’t leave consultation notes ‘for later’. In my experience, successful claim being made against your practice. Here are my top most insurers consider all notes being written up at the three tips for minimising claims in your clinic: time of the event or directly after as best practice. If they cannot be completed immediately, then they should be 1. Record keeping written up by the end of a shift.

If a claim is alleged against your practice, your files and records are • Do use black ink if you are going to handwrite notes to what insurers will rely upon to provide them with the evidence they minimise the risk of fading. need to try and successfully defend your position. However, with • Don’t use correction fluid, erasers, marker pen or overwrite the introduction of the new EU General Data Protection Regulations any text when making corrections to patient records. If (GDPR) taking effect next year,2 insurers will also be considering the corrections need to be made, then a line through the risk associated with the storage and security of your patient records. incorrect text (so it’s still legible), with the date, time and a They will also consider whether there has been a failure to exercise the signature is considered best practice by most insurers. required duty of care to securely store these records in line with the • Do ensure that all electronic records are securely backed new regulations.3 An insurer would consider your records to include, up and that back-ups are tested regularly. It is likely that this but not limited to: consultation records, emails, telephone notes or will he handled by your security/technology provider. call recordings, photos or images, text or social media messages and • Don’t amend computer records; create a new entry health records. From a GDPR perspective, you should extend this referring to the incorrect record. definition to any single piece of data held about any individual, not just patients, but also employees and prospective patients too, as this is considered personal data and therefore falls under GDPR.2 2. Consent Since the Montgomery case of informed consent in 20155 (and From an insurance/risk management perspective, the following is subsequently Crossman and Webster in 2016/17),6 consent has been a considered good record keeping: hot topic for all within the insurance industry. Insurers will be interested • Full and factual information, which includes relevant history, in understanding your processes for obtaining the required consent full details of all examinations, assessments, investigations and from your patients, in line with the increased obligations the recent findings, and details of any concerns or referrals such as mental changes have created. As opposed to reviewing your actual consent wellbeing assessments. Details of any problems/complications forms, underwriters will often focus on obtaining an understanding

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of your consultation process, while a number of insurers will offer to review these forms for practitioners.

An underwriter will be looking to establish that your consultation process allows adequate time to: • Identify if there are any underlying medical conditions that need to be considered prior to treatment.

• Discuss all the medical risks, not just those deemed relevant, associated with procedures being discussed.

• Consider the reasons for treatment and access the mental and psychological wellbeing of the patient to confirm if referral to another experienced professional, such as a psychologist, is required.

• Provide the patient with suitable time for reflection prior to treatment, which will depend on the treatment, but insurers take guidance from bodies such as the General Medical Council.7 In addition, I have found that the underwriter will usually want to ensure that there is confirmation that all of the above is suitably understood and certified by the patient, as well as being accurately documented and recorded by the practitioner. They will also want to confirm that your practice has processes and procedures in place that include: • Training around consent, the consultation process and managing customer expectations.

• Quality assurance including file/consultation reviews, providing feedback, implementation of additional training and follow up/ check back on completion of the required training to ensure that your staff are developing their skills for the benefit of your patients.

• Customer reviews/satisfaction monitoring following treatment and the use of that feedback as a way of improving services.

• Identifying and referring patients where there are concerns around their mental wellbeing.

The above will provide insurers with comfort that you have suitable processes in place for adequately accessing and obtaining informed consent from your patients. This alleviates some of the concern that insurers have in regards to defending a claim where there has been an allegation of failure to obtain adequate consent.

3. Complaints handling Complaints against medical practitioners have increased nationally.8 This is following the impact of the Francis Report,9 which discussed the leadership of staff at Stafford Hospital, and other similar industry reviews such as Keogh. Additionally, the impact of social media as a forum to share news has increased public awareness and expectations. However, not all complaints need to evolve into negligence claims and, in my experience, effective management of complaints can reduce the chance of them becoming so. A survey

by The Medical Protection Society in December 2016 found that something as simple as saying sorry could reduce claims, with 76% of patients surveyed saying that they would be less likely to complain if they had received an apology.12 Obviously, from an insurance and risk perspective, you have to balance apologies with the obligation not to admit liability found within all policy wordings, so I would always recommend taking the advice of your insurer on how they would like any apology to be worded. When it comes to managing complaints, underwriters will attain additional comfort in the risk posed by a practice that can demonstrate that they have: • A clearly documented complaints process that is communicated to the patients as part of the consultation process.

• A process for reviewing complaints after the event, to understand

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how they could be avoided in the future and make improvements to their risk management processes as a result of these findings.

• A process for identifying patterns of complaints and re-training staff/practitioners where required to mitigate repeat complaints.

• A culture where staff/practitioners will raise internal issues or incidents openly so that the practice can uphold its duty to the patient.

• Have a complaints’ register showing previous complaints, the process of how these were handled and the outcome.

The last point is an interesting one because some companies may question the benefit of a complaints’ register, suggesting that by showing insurers that you have had lots of complaints, it may increase your premium. However, demonstrating that you have a process where you record not only complaints, but also timeframes, key dates, outcomes, retraining or remedial action and a system for accessing patterns and mitigation, is of huge benefit. This is because it will demonstrate to insurers that you understand the need for effective risk and complaint management and you have tools to identify risks, which will mitigate the chance of repeat claims.

Conclusion The three areas highlighted in this article are integral to each other when it comes to effective risk management. They will not stop a claim being made against your practice, however, the chances of an allegation being successful could be reduced. Managing the patient expectations throughout their care at your practice is paramount to a harmonious relationship and makes it easier to have those difficult conversations when things don’t go according to plan or complaints arise. When issues do occur, record keeping will become your, and your insurer’s, best friend.

Disclosure: Martin Swann is the divisional director of Enhance Insurance.

Martin Swann is the divisional director of Enhance Insurance and has been insuring medical and healthcare professionals and businesses for more than 15 years.

Swann has extensive experience in risk identification, mitigation and management and provides advice on how best to reduce the risks faced by your practice.

REFERENCES 1. Emmet Vaughan & Therese Vaughan, Fundamentals of Risk and Insurance, 11th edition, John Wiley & Sons, 2014.

2. Martin Swann, ‘Getting Ready for GDPR’, Aesthetics journal, July 2017. <https://aestheticsjournal. com/feature/getting-ready-for-gdpr> 3. Example of a cyber proposal form which outlines the kind of information Insurers look at in regards to Data Security. <https://www.aig.co.uk/content/dam/aig/emea/united-kingdom/documents/ Financial-lines/Cyber/aig-cyberedge-application-form.pdf> 4. ICO, Overview of the General Data Protection Regulation (GDPR),2017 < https://ico.org.uk/media/ for-organisations/data-protection-reform/overview-of-the-gdpr-1-12.pdf> 5. Katie Gollop QC and Frances McClenaghan, The Latest on CONSENT and CAUSATION, Serjeants’ Inn Chambers, <http://ukhealthcarelawblog.co.uk/rss-feed/76-the-latest-on-consent-and-causation> 6. 12 King’s Bench Walk, Rodney Crossman v St George’s Healthcare Trust, 2017,<https://www.12kbw. co.uk/rodney-crossman-v-st-georges-healthcare-trust-2016-ewhc-2878-qb/> 7. GMC, ‘Giving patients time for reflection’, Guidance for doctors who offer cosmetic interventions, 2016, <http://www.gmc-uk.org/guidance/ethical_guidance/28712.asp> 8. Rebecca Smith, ‘Social media driving rise in complaints to GMC: report’, The Telegraph, 2014 <http://www.telegraph.co.uk/journalists/rebecca-smith/10978904/Social-media-driving-rise-incomplaints-to-GMC-report.html> 9. The Mid Staffordshire NHS Foundation Trust Public Inquiry 2010. <http://webarchive. nationalarchives.gov.uk/20150407084003/http://www.midstaffspublicinquiry.com/> 10. Keogh, B, Review of the Regulation of Cosmetic Interventions (2013) <https://www.gov.uk/ government/uploads/system/uploads/attachment_data/file/192028/Review_of_the_Regulation_ of_Cosmetic_Interventions.pdf> 11. Rebecca Smith, ‘Social media driving rise in complaints to GMC: report’, The Telegraph, 2014 <http://www.telegraph.co.uk/journalists/rebecca-smith/10978904/Social-media-driving-rise-incomplaints-to-GMC-report.html> 12. The Medical Protection Society Limited, ‘Survey shows the value of saying “sorry” in healthcare’, 2016. <https://www.medicalprotection.org/docs/default-source/pdfs/press-releases/uk-pressreleases/the-value-of-saying-sorry-in-healthcare.pdf?sfvrsn=4>

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Taking a Medical History Aesthetic nurse prescriber Jenny O’Neill shares her advice on collating a patient’s medical history during pre-treatment consultation The pre-treatment consultation is the first major step towards gaining important information that enables the practitioner to develop a safe, successful and appropriate treatment plan. It also facilitates the opportunity to gain an insight into the patient’s motivations and aspirations for attending an aesthetic clinic.

The basis of the consultation relies on the patient completing a comprehensive and relevant medical history form. This will cover their medical, psychological and social health status, including social factors which may influence a patient’s treatment timing or aftercare such as exercise, alcohol consumption or travelling abroad. In my experience, patients’ motivation for treatment is usually related to their desire to enhance their sense of personal and social wellbeing and might well be triggered by a significant event in their social diary, perhaps a wedding, a big birthday or a school reunion. It may be related to presenting themselves well in the work environment or they may want to alter their appearance for personal satisfaction alone. Whatever the motivation, it is crucial that we inform patients of the risks as well as the benefits of treatments, set realistic

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expectations and gain informed consent for their treatment plan.

What should an assessment include?

The main goal of any clinical assessment is to get a standardised and quantifiable understanding of a person’s physical and mental health and wellness.

Gaining informed consent for treatment and prescribing responsibly is a legal requirement. If there is no valid consent, then the patient could take legal action against the health professional.1 A comprehensive medical history form should therefore include the following information:2,3 • Name, age, and occupation – this may influence the timing or type of treatment offered, for example if the patient works in a hot environment, undertakes significant physical exercise or travels abroad.

• Current and past medical and surgical history – this will include dates of significant treatments or operations.

It is worth noting that patients who have auto-immune conditions may be

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unsuitable for a number of treatments offered in aesthetic medicine.

Psychiatric history – this should include treatment for depression, anxiety or body dysmorphic disorder (BDD), which, according to a study by Aesthetics and Cosmetic Surgery for Darker Skin Types, affects 15% of patients seeking cosmetic surgery.4 It is important that this is noted, as patients could consider treatment as a route to improving self worth or increasing happiness and aesthetic treatment may not give them this physcological satisfaction. In the case of BDD, they will obsessively visualise themselves as imperfect, making it impossible to set realistic expectations.

Occasionally, a practitioner may be looking to assess the patient’s capacity to give informed consent for treatment.

Family history – this must comprise allergies, or conditions which aren’t genetic but have familial tendencies and are worthy of consideration. For example diabetes, which may affect a patient’s risk of infection5 or polycystic ovaries, which may indicate a patient’s need for regular laser hair removal.

Social history – this may incorporate lifestyle questions relating to minimising downtime or timing treatment to exclude any planned activity that contraindicates safe post-treatment recovery. For example, travelling long-haul in the immediate future, being in a hot climate or doing strenuous physical activity.

Systemic enquiry – a systemic review is a traditional comprehensive sweep of all bodily systems, to identify any symptoms which may otherwise be missed. It can be presented as a checklist and can be altered, depending on the procedure the patient will have.6 This is to ensure all aspects of the patient’s health status are assessed and that no relevant information is missed.

Drug history – including over-thecounter remedies such as aspirin, complementary therapies, recreational drugs and any drug allergies. There are many ‘natural’ remedies that patients take and are blissfully unaware of the side effects, for instance, omega 3 fish oils, which can thin the blood and inhibit wound healing7 and St John’s Wort, which could also have significant adverse interactions with certain medicines and procedures such as the suture lift.8 It’s recommended that patients should stop taking supplements

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such as these two weeks before treatment.8 Other allergic responses – for example hay fever, eczema, food allergies, plaster and latex.

A history of hypertrophic scarring – this is important as skin may heal differently.

Wounds, and even injection points, can scar significantly if the patient has a history of hypertrophic scarring.

Previous aesthetic procedures – this helps to get a clear history of the patient’s journey and experience.

Review – it’s important to regularly review the patient’s medical history to include any new conditions or relevant data and to ask patients to sign their medical history form at each treatment session, confirming that nothing has changed since their previous treatment session. I always review a patient’s treatment results between two to four weeks post-treatment in order to know that a satisfactory end point has been achieved and to schedule their next treatment or review, if relevant.

Summary – a summary of all of the above information, which will enable practitioners to quickly assess the patient’s relevant medical history following the consultation.

Health risks Bearing in mind there are usually no previous medical notes to refer to unless we request them, we must be certain that factors relating to the patient’s past or current health will not create an unacceptable treatment risk.

Medical notes generally can’t be taken from practitioners who have previously treated the patient as different treatment protocols, dosage and medical devices may have been used. Details relating to cancer, unstable diabetes, heart conditions, auto-immune diseases, degenerative diseases of the nervous system or any long term medical conditions must be assessed and, if there is concern, permission should be sought to contact the patient’s GP or lead physician for further information and a second opinion.

Details of allergies or sensitivities need to be requested of the patient, who may not appreciate the importance of them. A good example of this is food allergies; an allergy to eggs, for example, would contraindicate a treatment involving the use of botulinum toxin type A, as one of the excipients used in its production is human serum albumin and therefore an allergy to albumin is a

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Budget considerations A difficult dilemma for the practitioner, particularly in a private clinic, is the matter of budget. We have a duty of care to make recommendations as to which treatments we think will give the patient best results, but if this is outside of their budget we may have to think again. The dilemma for any medical professional is all around being ethical so that we have to recommend what, in our opinion, is going to work best and question whether we resort to a less costly alternative to meet with the patient’s budget. It’s important to advise the patient of the implications of the less costly treatment package and whether it will take longer to achieve or if it will compromise their desired outcome, not forgetting to document this advice.

contraindication to treatment.9 To avoid complications from allergies, test patches can be used for some treatments, such as lasers, which can be done during the consultation. The test patch is carried out using different laser settings on very small areas to identify the most effective results at the lowest setting.

Of course, medical information is often only relevant to particular treatments, so patients could query why certain questions are being asked and why the medical information requested covers such a wide area. As many patients embark on multiple treatments over time, it’s sensible to take as comprehensive medical history as possible, right from the beginning. I explain to patients that in order to keep their medical history up to date, they will need to sign to verify that their medical history hasn’t changed prior to each treatment session.

The legalities The legal aspects of medical history and consultation notes state that medical records should fully document the progress of a patient’s care, recording all decisions taken and the evidence on which those decisions are based. Added to this, records should be clear, accurate and contemporaneous. They need to demonstrate professional integrity and justify what you have done.10 Remember that in the eyes of the law, if you didn’t write it, you didn’t do it! From a legal point of view, good notes can be likened to a watertight alibi and should answer these fundamental questions:10 • Who – patient’s name, date of birth and doctor/nurse’s identity, qualifications, signature of both patient and practitioner.

• When – date and time of when the patient was seen, tests undertaken or treatment given.

• What – a record of what was done, said, instructed, observed.

• Why – a justification of decisions taken in regards to treatment and aftercare.

Additionally, in our specialty, the off-licence use of prescription drugs is commonplace and therefore, we need to check that there is no comorbidity or conflict with any other medication the patient may be taking when prescribing. We should inform the patient if we propose to use drugs off-licence and detail the reasons why, complying with regulatory standards and prescribing ethics.11 An example of this is Allergan’s botulinum toxin product, which is licensed for treatment of the glabella and crow’s feet lines but is used off-licence to treat other areas of the face, such as the forehead.12

How to record information To maintain a conversation at the same time as taking good notes is a skill that seasoned practitioners have honed to a fine art. At Aspire Clinic, we have a consultation checklist for each individual procedure so that all practitioners can, at a glance, make sure that all information on every aspect of that particular treatment has been given.

We encourage our practitioners to actively go through this list with the patient at the end of the consultation so that patients can recognise the subjects covered and, if unsure, can request information to be repeated or clarified further. Practitioners should ensure they have a relaxed conversation with the patient rather than achieving a ‘tick box’ exercise, so you need to be proficient in consultation skills and be knowledgable about your subject, utilising the checklist to make sure you haven’t omitted anything.

It’s also worth remembering that patients have a right to access both paper and electronic records,12 so it is not wise to write personal observations or remarks that might cause offence. I recommend that full records

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Excellent communication skills are paramount to a meaningful and successful consultation, bearing in mind that ineffective communication is the most common reason for complaints against doctors are kept on paper and then any information that requires ongoing consideration is highlighted in the electronic record to be easily visible to all practitioners.

Ensuring communication The success of the consultation relies on creating a positive practitioner-patient relationship and the ability to be an active listener. Allowing patients to talk without interruption enhances patient satisfaction and the efficacy of the consultation.

A study by Beckman and Frankel11 suggests that a practitioner will interrupt the patient after an average time of 18 seconds, so it requires practice not to do this. Excellent communication skills are paramount to a meaningful and successful consultation, bearing in mind that ineffective communication is the most common reason for complaints against doctors and the majority of malpractice allegations arise from communication errors.13 Patients will need verbal and non-verbal encouragement from you to maintain the flow of the conversation, but during this time you can gain a lot of information which will allow you to: • Observe the demeanour of the patient and whether they are worried, anxious or depressed • Listen to their story and gain insight about why they’ve come to see you • Explore their own ideas about what their aesthetic challenges are and what the solutions might be • Observe their facial expression, how their facial muscles move, any asymmetries or

other relevant features that may relate to the treatment solutions you may discuss Consultation in an aesthetic setting will include physical examination and photographs of the treatment areas. These will be used to compare with post-treatment photographs, assessing progress and affirming this with the patient who may have ‘forgotten’ what they looked like before treatment commenced.

Educating your patients Patients often visit an aesthetic clinic completely unaware of the treatment possibilities and what’s involved. They may have a certain amount of knowledge but may get in a muddle, for instance, confusing botulinum toxin and dermal fillers. They may, on the other hand, be very knowledgeable but have fixed ideas about the treatment giving them the results they’re looking for, whilst the practitioner is aware that they may get a better result from a different treatment altogether. The consultation is the ideal platform to educate the patient and discuss which treatments are going to be most effective and why, as well as providing the opportunity to give them treatment information leaflets and treatment costings.

professionals should become patient advocates in their approach to consultation and should explore patients’ desired outcomes, invite patients’ questions and set realistic expectations, as this will go a long way towards building a close and honest patient relationship, providing an excellent platform for the ongoing relationship between patient and practitioner.

Jenny O’Neill is a nurse prescriber and has been working in aesthetics for 15 years. She ran a busy Harley Street clinic prior to opening the Aspire Clinic in Reading 10 years ago, where she is clinic director. O’Neill considers taking a full patient medical history and giving a comprehensive initial consultation key elements of good practice.

REFERENCES 1. RCN, Consent Advice Guide (London, Royal College of Nursing) < https://www.rcn.org.uk/get-help/rcn-advice/consent#The%20 need%20for%20consent> 2. GMC, Guidance for doctors who offer cosmetic interventions (London: General Medical Council, 2016) <http://www. gmc-uk.org/Guidance_for_doctors_who_offer_cosmetic_ interventions_210316.pdf_65254111.pdf> 3. Prendergast, P & Shiffman, M. Aesthetic Medicine: Art and Techniques (Berlin: Springer-Verlag Berlin Heidelberg, 2012), p. 15 4. Grimes, P. Aesthetics and Cosmetic Surgery for Darker Skin Types (USA: Lippincott Williams & Wilkins, 2008), p. 39 5. Pai, G. Complications in Cosmetic Dermatology: Crafting Cures (London, JP Medical Ltd, 2016) p. 142 6. Chatten, K et al, ‘Guide to History Taking and Examination’ (London, UCL Division of Medical Education, 2012) p.10 7. Agha, S. Supplements to Avoid Before Plastic Surgery (US, Plastic Surgeon Newport Beach) <https://www. plasticsurgeonnewportbeach.com/supplements-to-avoidbefore-plastic-surgery/> 8. Prendergast, P & Shiffman, M. Aesthetic Medinicine: Art and Techniques (Berlin: Springer-Verlag Berlin Heidelberg, 2012) p. 394 9. Bartlett, J & Jeanus S. Clinical Ocular Pharacology, Fifth Edition (Butterworth-Heinemann, Elsevier Health Sciences, 2008) page 379 10. Fernie, G. Medico-legal - The importance of good records (London: GP Magazine, 2009) <http:// www.gponline.com/ medico-legal-importance-good-records/article/896428> 11. Beckman HB, Frankel RM, The effect of physician behavior on the collection of data. (Philadelphia: Annals of Internal Medicine, 1984) p. 692-6 12. Allergan. BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Information (US: Allergan, 2016) <http://www.botox.com> 13. Tidy, C. Electronic Patient Records (Tyne and Wear: Patient,2015) <https://patient.info/doctor/electronic-patient-records>

Summary In conclusion, for a successful pre-treatment consultation, practitioners should ensure that they take an accurate and comprehensive medical history from their patients, whilst also engaging positively with them and creating an excellent communication pathway. I suggest that all aesthetic

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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Consulting with Transgender Patients Dr Helen Webberley details the important considerations to make when conducting a consultation with a transgender patient Patients whose gender identity varies from the gender they were assigned to at birth may visit an aesthetic clinic to undergo non-surgical treatment, which can help them appear more feminine or masculine, depending on their requests.

Visiting an aesthetic clinic could be a crucial step towards easing any dysphoria that transgender patients may have. It is important to bear in mind that as a transgender person, embarking on this process can be highly stressful and they may have faced previous instances of lack of support from professionals. Ensuring you are aware of their needs and making minor changes to your internal processes can lead to a more rewarding experience for all those involved, and give the best chance of an aesthetically pleasing result for the patient.

Using appropriate language When it comes to treating members of the transgender community, it is vital to get the language right. For some, being referred to as a transman or a transwoman is entirely acceptable, whereas others may want to forget that they were ever any gender other than the one with which they identify.

There are many glossaries available online that you can use to familiarise yourself

with terminology, to ensure you do not use language which may cause offence. The Stonewall glossary, which campaigns for acceptance for lesbian, gay, bisexual and transgender people, is a good place to start.1 Generally speaking, the term transgender is broadly acceptable for those who identify as the gender opposite to that which they were assigned at birth. ‘Transsexual’ is regarded as a word to avoid as the inclusion of the word ‘sexual’ indicates biological sex or sexual orientation, neither of which are relevant when speaking about gender identity.2 In addition, you should refrain from using ‘transvestite’, a term historically used to refer to cross dressers/drag queens/drag kings, which is no longer used in the English

language and is considered pejorative.2 Incorrectly addressing the patient can cause anxiety, not only on the part of the patient but for the practitioner and possibly the receptionist.

Patients seeking feminisation/ masculinisation treatments may be referred by their GP to you. In these cases, their referral may still have their birth name, which may be male for example, yet they present as female. It could be embarrassing for a masculine name to be called out when the patient looks overtly feminine. Where it is clear that your patient is transgender (if they have been referred by their GP for feminisation/masculinisation treatment for example), one option may be to leave out the pronoun altogether and instead use the initial, e.g. ‘N Brown, the doctor will see you now’. I advise practitioners to always use this modern way of addressing patients in their clinic. The most important consideration when consulting with a transgender patient is to treat them as you would any other patient – with respect for their identity and their clinical needs.

Creating a conducive environment Asking yourself a few simple questions about your clinic can help make your environment more trans-friendly. For example, are there only male and female toilets or are there gender neutral options?

Depending on how many toilets you have, say you only have two (one male, one female), it may be better to just have gender neutral ones to avoid segregation.

When the patient is making an appointment, ensure that reception staff enquire if they would like a chaperone to accompany them for any clinical examinations. The General Medical Council’s (GMC) Good Medical Practice guidance states that this should be offered to all patients whenever possible.

Having an impartial observer present can make the patient feel more comfortable in a sometimes daunting situation.3 Amongst

The right to fair treatment on the NHS Gender variance is not a mental illness and in fact, in January 2017, Denmark was the first country to declassify it as such,5 with the United Nations set to follow suit in 2018.6 However, a transwoman/transman may be asked to produce two assessments from mental health professionals, to ‘prove’ that they are not mentally impaired before qualifying for a treatment such as breast enhancement/reduction surgery on the NHS.7 This is not the case for those who are assigned female at birth requesting breast surgery.

While it is important to look for signs of mental distress, anguish or ill-health in any patient, the criteria for gender-affirming surgery outlined by the NHS7 do not necessarily fit all situations and treatment should be planned and negotiated on an individual basis.

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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other points, the guidance states that a chaperone should usually be a health professional and you must be satisfied that they will be sensitive and respect the patient’s dignity and confidentiality. Giving the patient the option of a male or female chaperone is also important.3 Does your IT or customer relationship management system allow for other genders or is it limited to male or female? It would be helpful to give patients the opportunity for options such as non-binary, transwoman, transman, other, or ‘rather not say’. Not all people want to use these options, but it is important to make them available for those who do. On your patient questionnaires, do people have to give a honorific title? Can a person choose alternatives to Miss, Mrs or Mr? Gender neutral options such as Mx may be more suited to some patients.4 There are so many different identities, suffixes and pronouns, that it is important to let the patient choose. You could ask, for example, ‘May I ask which title you would like me to use, and should I call you Miss or Mr or something else?’

Understanding the patient’s request The practitioner should establish early on what the long-term hopes and expectations of the patient are. Not all transgender patients will want all the possible treatments or seek full sexual reassignment surgery.8 For some, their genitals may be perfectly acceptable if they are hidden, but they may instead have an issue with their ears, nose or chin, for example, so may be interested in having procedures such as non-surgical rhinoplasty or facial contouring, which is where aesthetic practitioners can help.

Ask for an idea of what effect they are trying to create and get an idea of their hopes for the finished ‘look’. Ask simple questions such as, ‘What kind of size were you hoping for?’ and ‘What type of shape would you like to achieve?’ It is important to consider that this procedure or treatment might be the first of many, and the nose reshaping they originally came in for might be the first step towards full facial feminisation/masculinisation. Offering a consultation where you take into account all of the treatments the patient may be likely to request is essential at this early stage, so that you ensure the patient fully understands how you can achieve the most natural results.

If your patient is in the early stages of hormone therapy, it may be that more changes are likely to occur, so take that into account when taking the patient’s medical history. As hormone treatment progresses,

Aesthetics Journal

fat redistribution will take place and can reshape a face quite dramatically.10 Consider, for example, the angular jaw of a man who has gone through male puberty, and the soft plumper skin of someone who has gone through female puberty – they are quite different and it is surprising how much hormones can change the shape of the face, even if you swap them from male to female, or vice versa, later in life. It is important to bear this in mind when consulting for facial treatments so you are aware of how their face may develop with the progression of hormone therapy and how this may impact aesthetic treatment.

Try not to make judgements based only on appearance; if a female patient comes to see you for a treatment, where pregnancy or breast-feeding is a contraindication, asking the question would be acceptable. A transman may have a uterus and may engage in vaginal sex, meaning there is a chance they could be pregnant.

Again, choose your words carefully, you could say, ‘I have a list of conditions where it might not be best for you to have this treatment today, this might include something like pregnancy or breastfeeding, can I ask if any of those might apply to you?’ Treatments where this may apply include botulinum toxin type A injections which, according to the NHS, is not recommended when you are pregnant or breastfeeding.11 To disclose or not to disclose The question of whether or not you should disclose a patient’s transgender status when liaising with their GP should be considered on a case-by-case basis.

The GMC guidance on Good Medical Practice in relation to transpatients states, ‘Disclosure must have direct relevance to the treatment involved or likely to be involved. GPs and other medical practitioners should not automatically disclose a patient’s gender history when referring a person’.5 Gender reassignment, alongside the headings of age, disability, race, religion or belief, sex, sexual orientation, marriage and civil partnership, as well as pregnancy and maternity, are known as ‘protected characteristics’ according to the Equality Act 2010, which means they should only be disclosed if clinically relevant.6 In my opinion, it is good practice to always offer to liaise with the patient’s GP if they’re having treatment involving body changes or prescription medicine.

Of course, at times, it may be clinically

Aesthetics aestheticsjournal.com

relevant to disclose a patient’s gender reassignment if you are referring them to another practitioner, other than their GP. For example, if a person has had hormone treatment for male to female gender affirmation, but still had some persistent hair growth on their chin, it might be pertinent to explain this to the laser clinic that you are referring them to.

Sample language you could consider using includes, ‘I am going to refer you to the laser clinic to help you with this. It would be useful for them to know that you are taking gender affirming hormones so they can offer you the best treatment, is it okay that I mention this in my letter?’

Conclusion Treating transgender patients may not be common for a lot of practitioners, however it is important to be aware of how to handle these sensitive issues. By making sure your clinic is trans-friendly, you will open the door for safe treatment in a non-judgmental way. The principles are the same as for any patient, don’t assume, don’t offend, don’t judge. If you are not sure, then ask.

Dr Helen Webberley is a GP with specialist qualifications in sexual health and an interest in hormone-related health issues. She runs medical advice and treatment portals through websites MyWebDoctor and GenderGP, through which she supports members of the transgender community and others needing specialist advice.

REFERENCES 1. Stonewall, Glossary of Terms, (2017) <http://www.stonewall.org. uk/help-advice/glossary-terms> 2. GLAAD (UK:Media Reference Guide – Transgender, 2017) <https://www.glaad.org/reference/transgender> 3. GMC (UK: Intimate examinations and chaperones, 2017) Guidance http://www.gmc-uk.org/guidance/ethical_ guidance/30200.asp 4. Oxford Dictionary, (UK: Mx, 2017) <https://en.oxforddictionaries. com/definition/mx> 5. GMC (UK, Respect, confidentiality and the law, 2017) <http:// www.gmc-uk.org/guidance/ethical_guidance/28861.asp> 6. Equality and Human Rights Commission, (UK: Protected Characteristics, 2017) <https://www.equalityhumanrights.com/ en/equality-act/protected-characteristics> 7. NHS England (UK: Interim Gender Dysphoria Protocol and Service Guideline, 2013) <https://www.england.nhs.uk/wpcontent/uploads/2013/10/int-gend-proto.pdf> 8. Remedy’s health communities (US: Transgender Health, 2017) <http://www.healthcommunities.com/transgender-health/ surgery.shtml> 9. Vanderburgh, R. Transition and Beyond: Observations on Gender Identity (US, Q Press, 2007) page 83 10. NHS, (UK: Botox Injections, 2016) < http://www.nhs.uk/ Conditions/cosmetic-treatments-guide/Pages/botulinum-toxinBotox-injections.aspx>

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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In Profile: The Kings Dr Martyn King and nurse prescriber Sharon King reflect on their varied careers and achievements in aesthetics

“Aesthetics is a challenge, you have to keep up to date and improve your skills, but I love it” If you combine the experiences of aesthetic practitioner Dr Martyn King and nurse prescriber Sharon King, there are not many areas of non-surgical aesthetics that have been left untouched. They both have, each in their own right, played their part in developing the specialty and, together, are still coming up with ways to improve it. “Sharon and I have had quite a few lightbulb moments,” says Dr King. “Usually when we are sitting together with a glass of wine and then suddenly,” he laughs, “we will just come up with our next absolute genius idea!” From setting up the Aesthetic Complications Expert (ACE) Group to the creation of distribution company Cosmedic Pharmacy, there have been many ‘lightbulb’ moments along the way, but for Dr King, it all started with a dream and sheer determination to become a medical practitioner. “It was a pipe dream to become a medic,” says Dr King, explaining, “I didn’t think I would ever achieve it. I did my A levels, I did very well, but I didn’t get into university the first time around. I didn’t want to be knocked back again, so I did an extra couple of A levels; I then had six altogether, I got some experience, and then had offers of unconditional places at a number of universities.”

Dr King always had his heart set on becoming a surgeon, but it wasn’t until he completed his medical degree at Leicester University and started working in hospitals that he changed his mind, and instead trained to become a GP. “One thing I didn’t want to do all the way through medical school was be a GP, and obviously, that is where I ended up! But actually, it was the best decision I ever made,” he says.

Dr King is still a GP and has been a partner at a practice in the West Midlands since 2003. “The great thing about being a GP is you can split your time and develop other skills on the side,” he says.

Some of these skills were in medical aesthetics, which led to the creation of the Cosmedic Skin Clinic, “Cosmedic, as it was known then, is about 14 years old now. I set it up after doing some courses in aesthetic medicine, I started with a course in toxins, and then the natural progression was to do fillers and this is when I met my wife Sharon.”

Nurse prescriber Sharon King, who worked as a field clinical specialist (FCS) for medical aesthetic company BioForm Medical before they were acquired by Merz Pharma Group, was introducing Radiesse for the hands into the UK. She went to Cosmedic to present it to Dr King and his then business partner, but it wasn’t until a year later, when they met again at an awards ceremony that they really got to know one another. A few months later they started dating and have now been together for nine years and married for six.

Reflecting on his career, Dr King believes he got into aesthetics at just the right time, saying, “Back in the day, there were not many of us doing aesthetics, we knew all the people who were working in the specialty and we helped each other out. I think the industry has changed quite a lot now.” He continues, “Treatments and procedures have changed; it used to be just Botox [sic] or filler, and the filler was either collagen or Restylane. Now, we have more than 100 fillers on the market. From my point of view, there is no other specialty in medicine that is growing at such a rate as aesthetic medicine. It is a challenge, you have to keep up to date and improve your skills, but I love it.”

Looking back, it was one of Dr King’s ‘lightbulb’ moments, that he considers to be his ultimate triumph so far – the ACE Group. He explains, “Nobody used to mention complications, it was sort of brushed under the carpet. It wasn’t until it was being spoken about at a conference around nine years ago that it became obvious that everyone was doing something completely different and managed them in their own way. I believed the way complications were dealt with needed to have evidence-based medicine behind it, you had to be offering best practice. So, forming the ACE Group was about looking at the evidence; we took the best papers and advice and put it together to make simple and straightforward guidelines on what you should do and when to do it in the event of a complication. We have well over 600 members now and are one of the largest nonsurgical aesthetic organisations in the UK.” Dr King’s next window of opportunity came in the shape of Cosmedic Pharmacy. He explains, “I wanted to create a reliable service where I could get everything I needed, all in one place.”

He got together with a local pharmacist he knew through his GP practice five years ago and set up Cosmedic Pharmacy, which has gone, in Dr King’s words, ‘from strength to strength’.

Today, there is never a dull moment for Dr King; as well as running his clinic, leading training sessions, the ACE Group and Cosmedic Pharmacy, he writes a lot of articles for journals, speaks at conferences, and is a KOL for several companies. He says, “I guess I always try and be at the forefront of the specialty; there is always something new, there are always different things coming along and I think it is an exciting time. There is a lot more coming in aesthetics in terms of genetics, skin and ageing, and a lot more to do with nanotechnology. So, watch this space, there are interesting things on the horizon.”

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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“Every day is a school day – there is always something to learn” Sharon King comes from a family of builders, but it was her natural urge to care for others that led her into medicine. “I always loved caring, I was always caring for animals, and I knew from an early age I wanted to go into nursing,” she says.

Not only a qualified nurse but a qualified medical secretary, King completed her adult nursing qualification at Wolverhampton University in 1999 and has had a varied career in healthcare. She explains, “I did six years in dentistry as a dental surgery assistant and then went into maxillofacial surgery; it was something I was very interested in and it was always the surgical disciplines that interested me more than the standard medical disciplines.”

King ended up working in surgical theatres but then specialised in plastic and reconstructive surgery, working alongside many practitioners who have gone on to become specialty leaders.

“We were all very new to aesthetics then,” says King, “I used to scrub for Mr Ash Labib and then Mr Dalvi Humzah; I was Dalvi’s scrub nurse for a considerable length of time and that’s how I came into aesthetics.” King was in her early 30s when she met Mr Humzah. She says, “Aesthetics was very new and exciting back then and it was just an additional bolt on to the things I was doing,’ she explains, adding, “I thought, ‘this is going places and I want to be a part of it’.”

Learning alongside Mr Humzah, about 16 years ago, King would help him out with his private patients and some aspects of his training courses. King explains, “This was in Wordsley Hospital, in the West Midlands, which was the regional plastic surgery unit at the time. Then, I got a post at Nuffield Health Wolverhampton Hospital, did plastics there and worked alongside some maxillofacial surgeons.” Much like her husband, King decided to do some courses run by dermal filler and botulinum toxin companies, which, as she notes, “Was the progressive route everyone took in those days.” From there, King was appointed to a role with BioForm Medical, was involved in bringing Radiesse into the UK, and was the first FCS to use it. “And that is how I met Martyn,” she reiterates, adding, “When we got together, I was still working for BioForm but at weekends, I came across to see Martyn and I would help him out in his clinic, and then gradually I fully stepped into Cosmedic.”

A big part of King’s career has been her involvement with the British Association of Cosmetic Nurses (BACN). She says, “I have been a member for several years and I have been a board member for five years. The BACN is a great organisation with a great nursing fraternity and a wealth of knowledge. They really are at the forefront of aesthetic practice. I am very fortunate and

Aesthetics

happy to be a part of that,” she exudes. “There is a great deal of activity going on at the moment – the annual conference has grown, the amount of education has grown, we have been doing work with the Joint Council for Cosmetic Practitioners (JCCP) – it has been great to be part of it,” King adds.

When it comes to choosing the highlights of her career, King struggles to whittle them down, “To date, I have been very fortunate with my career and have had some wonderful opportunities. I have been able to work alongside some very talented people, particularly back in the early days, with some practitioners who are now very well-known international speakers,” she says. As well as the huge role education has played in King’s career, she has also had some fantastic personal achievements. She explains, “Winning Aesthetic Nurse Practitioner of the Year at the Aesthetics Awards in 2013 was a very humbling moment, to be held in such esteem, I am so grateful to this day; I am very proud.”

What treatment do you enjoy giving the most?

S: I get an awful lot of satisfaction from dermal filler treatments as you can be an artist when performing them.

M: If I had to pick one I would say PDO threadlifts; you can get some fantastic results.

What do you enjoy the most about the specialty?

M: The people I treat. You give some of them a mirror at the end of the treatment and they have a little tear of happiness in their eyes.

S: Happy patients. I think in general medicine you can’t always make someone better, and there are very sad times, but aesthetics gives you the opportunity to boost a patient’s confidence.

Do you have a motto that you follow?

S: Every day is a school day – there is always something to learn, it might be good, it might be bad, it might be impartial, but there is always something to learn.

M: When you are a trainer, if you don’t learn something yourself, it is a bad training day. The other one is never to do a treatment on someone you wouldn’t do to yourself.

Is there anything you would love to see change?

M: I would love to see aesthetic medicine recognised as a medical disciplinary in its own right, have college endorsement and proper training for it.

S: It is nice to think we can move towards some sort of official register, as Martyn says, but I think we are a long way off.

M: We need a royal college and it needs to be recognised.

In my opinion, it should have happened years ago.

Where do you see yourselves in 10 to 15 years’ time?

M: Sharon will probably be on a beach or a cruise ship!

S: [Laughs] Yes, definitely!

M: I won’t, I love it, I’ll still be here working away, I have no plans to stop…

S: I can never see myself stepping out of it completely.

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

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treatments. At the time of writing, a simple search of YouTube for ‘lip fillers vlogs’ that have been uploaded this month generates 2,760 results.4

The Last Word Dr Ifeoma Ejikeme discusses how the rise of beauty video bloggers has impacted aesthetic patients There is no doubt that social media has become an integral part of our lives and the ways in which our patients use it is continually evolving. With so many platforms and so much content available, our patients are now learning about aesthetic procedures from a variety of sources. Playing a big role in how our patients receive information are video beauty bloggers, or ‘vloggers’, who produce video blogs and share them on social media and video sharing sites such as YouTube. In 2017, US business magazine Forbes summarised who it believed to be the 10 top beauty influencers and, between them, they had 46,543,975 YouTube subscribers and a total reach of 135 million people.1 Beauty vloggers are acting as a resource for our patients to find out about the latest beauty trends and treatments, as well as aesthetic procedures, from someone whom they grow to trust. In a survey of more than 170,000 internet users, 42% said they had watched a vlog within the last month of the survey, and this rose to 50% for 16-24-yearolds and 25-34-year-olds.2 Being a beauty vlogger is, for some, a full-time job and some entrepreneurial YouTubers, such as Michelle Phan, have even set up cosmetic companies that have, so far, been successful.4 Popular beauty vlogger Zoe Sugg has 11.6 million YouTube followers and others have up to 16 million followers across all their social media platforms.4 While these particular vloggers aren’t necessarily known for talking about

aesthetic procedures, they demonstrate how incredibly influential vloggers can be; which brings us to wonder, how is this influence affecting our patients?

How vloggers may help our patients A study by Gannon et al. in 2016, which combined depth-interviews of beauty bloggers with a review of participants’ blogs and selfies, suggested that [beauty] bloggers can use selfies in a positive way to record product [or treatment] experiences.3 These videos are like journals and, when done well, I have found they can reduce nervousness around procedures and help build realistic expectations of results. This is generally because viewers have followed the vlogger’s journey and seen the continual improvement in results, as well as learnt about all the potential side effects and complications that can occur. The influence of vloggers and their reach can lead to an increase in sales of a new product or procedure as well. In my practice, over the last 12 months, I have seen an increase in requests for lip enhancement

How vloggers may hurt our patients Beauty vloggers come from all walks of life and often have no formal training in health or beauty. While this is of course not essential, it does mean that sometimes opinions can read as if they were facts. I recall a patient who had acne, watching a video that advised that coconut oil could help improve her complexion. This led to a severe acne breakout as coconut oil is pro-comedogenic.5 If it had been a medical practitioner producing the vlogs, I would expect that they would follow guidance on social media from the General Medical Council (GMC), Nursing and Midwifery Council (NMC) or General Dental Council (GDC), which would hopefully lower the chance of misinformation being shared.

The GMC states, ‘You must make sure the information you publish is factual and can be checked, and does not exploit patients’ vulnerability or lack of medical knowledge’.

It also notes that, ‘The standards expected of doctors do not change because they are communicating through social media rather than face to face or through other traditional media.’6 As well as this, some beauty vloggers are sponsored by companies that pay them to produce content about their product or services. It can therefore sometimes be unclear whether or not they are sharing genuine recommendations or being paid to advertise a product or service, with no control over the content. In the case of aesthetic treatments, there is a risk of a company paying a vlogger to only talk about the positive results that can be achieved with a treatment – leaving out any mention of side effects or complications. In response to calls for greater clarity on advertising in vlogs, the Committee of Advertising Practice (CAP) produced guidelines specifically for vloggers in 2015, that aim to help them better understand how and when advertising rules should apply. The guidelines state that, ‘If there is a commercial relationship in place, it needs to be made clear’ and goes on to

Some beauty vloggers are sponsored by companies that pay them to produce content about their product or services

Reproduced from Aesthetics | Volume 4/Issue 10 - September 2017

Aesthetics

discuss the various formats advertising content can appear in and how to inform vlog viewers of any commercial relationships.7 Of course, it is our responsibility as practitioners, not the vlogger’s, to ensure that all patients are fully informed of all aspects of a procedure prior to treatment. However, if the viewer of the vlog goes to an unscrupulous practitioner who does not offer a thorough consultation, then they could be at risk of experiencing side effects or complications that they were not prepared for and that the practitioner cannot manage.

What can practitioners do to help?

To begin, it is vital that we offer patients a thorough medical consultation and ensure that they are basing their final decision on whether to have treatment on the information provided in the consultation, not from what they have heard in a vlog.

In addition, I believe we should take ownership of the information our patients are receiving. Why not make your own videos and educational content, in a format your patients will watch, that also maintains our professional standards? As well as this, if you ever see incorrect information being shared online, why not reach out to the vloggers themselves? You could gently inform them of points they may not have covered and provide them with additional information they could share, which, in addition to promoting safe treatments, has the potential to increase their reputation and build their profile as a trustworthy medical aesthetics vlogger. Building a relationship with a vlogger in your area could benefit your clinic too.

There may be an opportunity to reach a partnership agreement, in which you waive a treatment fee in exchange for coverage of the services you offer. While the finite details are outside the scope of this article, it’s vital to note that any advertising content you produce together follows CAP guidelines and is conducted in a safe and ethical manner.

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Summary Beauty vloggers can clearly have a positive influence on our patients and our consultations, however, as discussed, there are a number of negative points associated with vloggers talking about aesthetic procedures. As practitioners, we should remain vigilant in our consultations to ensure that patients are making informed decisions before undergoing any aesthetic treatment.

Dr Ifeoma Ejikeme is the medical director of Adonia Medical Clinic and a NHS medical consultant in Acute Medicine, with extensive global training in medicine and surgery. Dr Ejikeme gained a Master’s in Aesthetic Medicine from Queen Mary’s, where she is currently a senior honorary lecturer. There she trains surgeons, dermatologists, doctors and dentists on safe and effective aesthetic procedures.

REFERENCES 1. Forbes (US: Top Influencers: Beauty, 2017) <https://www.forbes.com/top-influencers/ beauty/#57702dd93378> 2. Global Web Index (UK: GWI Trends, 2017) <https://app.globalwebindex.net/products/report/gwivloggers-trend-report-q1-2015> 3. Valerie Gannon, Andrea Prothero, ‘Beauty blogger selfies as authenticating practices’, European Journal of Marketing, Vol. 50 Issue: 9/10, (2016) pp.1858-1878, <https://doi.org/10.1108/ EJM-07-2015-0510> 4. YouTube (Lip Filler Vlogs, 2017) <https://www.youtube.com results?sp=EgIIBFAU&q=Lip+fillers+vlogs> 5. Kubba R, Bajaj A K, Thappa D M, Sharma R, Vedamurthy M, Dhar S, Criton S, Fernandez R, Kanwar A J, Khopkar U, Kohli M, Kuriyipe V P, Lahiri K, Madnani N, Parikh D, Pujara S, Rajababu K K, Sacchidanand S, Sharma V K, Thomas J. Factors precipitating or aggravating acne. Indian J Dermatol Venereol Leprol 2009;75, Suppl S1:10-2 6. GMC, Doctors' use of social media: Guidance, (2015). <http://www.gmc-uk.org/guidance/ ethical_guidance/30173.asp> 7. Committee of Advertising Practice (UK: Video blogs: Scenarios, 2015) <https://www.asa.org.uk/ advice-online/video-blogs-scenarios.html>

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Enhance Insurance enquiry@enhanceinsurance.co.uk 0800 980 776 www.enhanceinsurance.co.uk

f Fusion GT 0207 481 1656 info@fusiongt.co.uk www.fusiongt.co.uk

Medical Aesthetic Group Contact: Jenny Claridge +44 02380 676733 info@magroup.co.uk www.magroup.co.uk

Syneron Candela UK Contact: Head Office 0845 5210698 info@syneron-candela.co.uk www.syneron-candela.co.uk Services: Syneron Candela are global brand leaders in the development of innovative devices, used by medical and aesthetic professionals.

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Cambridge Stratum 01223 846881 info@cambridgestratum.com www.cambridgestratum.com

Galderma (UK) Aesthetic & Corrective 01923 208950 Email: info.uk@galderma.co.uk https://aesthetics.galderma.co.uk

Cosmetic Digital Aesthetics and Medical Cosmetics Digital Marketing and Web design

01159 140640 enquiry@cosmeticdigital.co.uk www.cosmeticdigital.co.uk

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TEOXANE UK 01793 784459 info@teoxane.co.uk www.teoxane.co.uk

MedivaPharma 01908 617328 info@medivapharma.co.uk www.medivapharma.co.uk Service: Facial Aesthetic Supplies

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Church Pharmacy 01509 357 300 info@churchpharmacy.co.uk www.churchpharmacy.co.uk

SkinCeuticals www.skinceuticals.co.uk contact@skinceuticals.co.uk

S O L U T I O N S

Eden Aesthetics Contact: Tania Smith +44 01245 227 752 info@edenaesthetics.com www.edenaesthetics.com www.epionce.co.uk

Beamwave Technologies 0208 191 7117 hello@beamwave.co.uk www.beamwave.co.uk

Schuco International (London) Limited 01923 234 600 sales@schuco.co.uk www.schuco.co.uk

Globe Aesthetic And Medical Technologies Ltd Email: info@globeamt.com URL: www.globeamt.com Telephone number: +44 1372 471100 HA-Derma IBSA Italia’s aesthetic portfolio UK Contact: Iveta Vinklerova 0208 455 48 96 info@ha-derma.co.uk www.ha-derma.co.uk Services: Distributor of IBSA’s Profhilo, Aliaxin, Viscoderm, Skinko

Thermavien Contact: Isobelle Panton isobelle@thermavein.com 07879 262622 www.thermavein.com

Merz Aesthetics +44 0333 200 4140 info@merzaesthetics.co.uk

v WELLNESS TRADING LTD – Mesoestetic UK Contact: Adam Birtwistle +44 01625 529 540 contact@mesoestetic.co.uk www.mesoestetic.co.uk Services: Cosmeceutical Skincare Treatment Solutions, Cosmelan, Antiagaing, Depigmentation, Anti Acne, Dermamelan

Aesthetics | September 2017

Vida Aesthetics Contact: Eddy Emilio +44 (0)1306 646526 vida-aesthetics.com info@vida-aesthetics.com Exclusive distributor of Tannic {CF] Serum, Uniq-White and Plenhyage

F I N A L I S T

2 0 1 7

GOOD SKIN

GLOWS

C onfidence shines

ONE TREATMENT AND UP TO 6 MONTHS OF FEELING GREAT1,2,*,†,‡

With Juvéderm® VOLITE you can improve your patients’ skin quality attributes — increasing smoothness,§ hydration and elasticity — for up to 6 months with just one treatment.2,†,‡,||

Utilising patented VYCROSS® technology,3 Juvéderm® VOLITE is injected intradermally and can be used for areas such as the face, neck, décolletage and hands.4

When your patients glow on the outside, they feel great inside.2,5 References: 1. Allergan Data on File INT/0655/2016. Juvéderm® VOLITE Clinical Study (V12-001), 6 months top line, patient satisfaction results. Sep, 2016. 2. Allergan Data on File INT/0653/2016. Juvéderm® VOLITE Clinical Study (V12-001), 6 months top line, summary. Sep, 2016. 3. Lebreton P, 2004. Réticulation de polysaccharides de faible et forte masse moléculaire; préparation d’hydrogels monophasiques injectables; polysaccharides et hydrogels obtenus. Publication number: WO 2004/092222 A2. 4. Juvéderm® VOLITE DFU. 73140JR10, Revision 2016-02-19. 5. Allergan Data on File INT/0448/2016(1).

Allergan Skin Quality Market Research Insights. Jul, 2016. 6. Allergan Data on File INT/0773/2016. Juvéderm® VOLITE Names. Oct, 2016. 7. Goodman GJ et al. Plast Reconstr Surg. 2015;136:139S–48S. Footnotes: * Based on FACE-Q satisfaction with skin mean score improvements at Month 1= 64.6%, Month 4= 60.3%, and Month 6 = 57.7% (p<0.001). Baseline satisfaction was 43.5%.1 † After a single treatment, which included initial (n=131) and top-up administered at Day 30 (n= 31).2 ‡ Study conducted using Juvéderm® VOLITE B without lidocaine.6 Added lidocaine enhances patient comfort during injections and has no substantive effect on the rheological properties of HA products.7 § Smoothness is defined as the absence of fine lines. ‖ Cheek skin hydration (secondary endpoint) improved significantly from baseline at Months 1, 4 and 6. Skin smoothness (primary endpoint) improved in patients at Month 1 (96.2%), Month 4 (76.3%) and Month 6 (34.9%). Five of the 10 cheek skin elasticity parameters (secondary endpoint) improved significantly from baseline at Month 1 and 4 but not Month 6.2 Please refer to the Juvéderm® VOLITE Directions For Use for further information.4

December 2016 UK/0869/2016