14 minute read
Cryotherapy in Aesthetic Practice
Dr Paul Charlson discusses the use of cryotherapy for benign dermatologic concerns in aesthetic practice and how it can benefit both your patients and business
Cyrotherapy is an established treatment for dermatological lesions and can be used for a variety of conditions including benign lesions such as viral warts, seborrheic keratosis, sebaceous hyperplasia, haemangiomas and lentigo, and pre-malignant lesions including actinic keratosis and Bowen’s disease. Many, if not most, GPs in the UK will no longer provide cryotherapy through the NHS for benign lesions.1 In fact, in November 2018 the NHS released the Evidence-Based Interventions: Guidance for CCGs document, which states in its update description for the removal of benign skin lesions that they ‘cannot be offered for cosmetic reasons’ and should only be offered in situations where the lesion is causing symptoms outlined in at least one of its criteria. Some examples of criteria include: the lesion is unavoidably and significantly traumatised on a regular basis, repeated infection, regular bleeding, regular pain and impacts function.2 I have found that many GPs also don’t offer treatment on a private basis, so there is certainly a gap in the market for aesthetic practitioners to do so. I believe that cryotherapy has become a more common and popular treatment in non-surgical aesthetic clinics and is a useful addition to your current treatment portfolio. In this article, I will explore the clinical aspects behind its use for treating cosmetic benign lesions, and also touch on the benefits it can bring to you from a business perspective.
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Training requirements Firstly, it’s important to recognise that the training requirements needed to identify and diagnose appropriate lesions for cryotherapy are different to those required for performing the actual cryotherapy treatment.
Diagnosis The practitioner must have the ability to make the correct clinical diagnosis of the lesion before treating it. This requires significant dermatological training to be considered safe and usually only general practitioners with extended roles (GPwER) or dermatologists can do this. Some dermatology nurse specialists and consultant dermatology nurses who have undertaken extensive post-graduate dermatology training may, as part of their extended scope of practice, be trained and assessed as competent to assess, diagnose and treat some skin lesions.3,4 Of course, a verruca on a young person’s foot is likely to be fairly obvious, but an apparent wart in an elderly person may be a squamous cell carcinoma, a common form of skin cancer. Pigmented lesions are of particular concern as treating them inappropriately with cryotherapy can alter the histology and prolong overall time to diagnosis,5 which is crucial in melanomas. Practitioners must therefore be trained in recognising such lesions for safe diagnosis before treatment.
Performing the treatment If you do not have the skills in diagnosing, you could ask your patient to obtain a diagnosis from their GP (with qualifications explained above) so that you can still perform the actual treatment in your clinic. If the lesion is diagnosed as benign, then the GP can refer to you for treatment. As mentioned, many GPs will not provide cryotherapy through the NHS nor on a private basis, so they will sometimes be relieved to have a provider they can trust to refer their patients onto. As with many skin-related treatments that are classified as cosmetic, one does not need to be a medical professional, just trained in performing the procedure. Personally, however, I only endorse that medical professionals, with appropriate training, perform this procedure in a clinical environment as there are possible clinical side effects (Table 1).6 Practitioners must have
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Azzalure Prescribing Information (UK & IRE) Presentation: Botulinum toxin type A (Clostridium botulinum toxin A haemagglutinin complex) 125 Speywood units of reconstituted solution (powder for solution for injection) Indications: Temporary improvement in appearance of moderate to severe: • Glabellar lines seen at maximum frown, and/or • lateral canthal lines (crow’s feet lines) seen at maximum smile in adult patients under 65 years, when severity of these lines has an important psychological impact on the patient. Dosage & Administration: Azzalure should only be administered by physicians with appropriate qualifications and expertise in this treatment and having the required equipment. Botulinum toxin units are different depending on the medicinal products. Speywood units are specific to this preparation and are not interchangeable with other botulinum toxins. Reconstitute prior to injection. Intramuscular injections should be performed using a sterile suitable gauge needle. Glabellar lines: recommended dose is 50 Speywood units divided equally into 5 injection sites, 10 Speywood units to be administered intramuscularly, at right angles to the skin; 2 injections into each corrugator muscle and one into the procerus muscle near the nasofrontal angle. Lateral canthal lines: recommended dose per side is 30 Speywood units divided into 3 injection sites; 10 Speywood units to be administered intramuscularly into each injection point, injected lateral (20 - 30° angle) to the skin and very superficial. All injection points should be at the external part of the orbicularis oculi muscle and sufficiently far from the orbital rim (approximately 1 - 2 cm); (See summary of product characteristics for full technique). Treatment interval should not be more frequent than every three months. The efficacy and safety of repeat injections of Azzalure has been evaluated in Glabellar lines up to 24 months and up to 8 repeat treatment cycles and for Lateral Canthal lines up to 12 months and up to 5 repeat treatment cycles. Not recommended for use in individuals under 18 years of age. Contraindications: In individuals with hypersensitivity to botulinum toxin A or to any of the excipients. In the presence of infection at the proposed injection sites, myasthenia gravis, Eaton Lambert Syndrome or amyotrophic lateral sclerosis. Special warnings and precautions for use: Care should be taken to ensure that Azzalure is not injected into a blood vessel. Use with caution in patients with a risk of, or clinical evidence of, marked defective neuro-muscular transmission, in the presence of inflammation at the proposed injection site(s) or when the targeted muscle shows excessive weakness or atrophy. Patients treated with therapeutic doses may experience exaggerated muscle weakness. Not recommended in patients with history of dysphagia, aspiration or with prolonged bleeding time. Seek immediate medical care if swallowing, speech or respiratory difficulties arise. Facial asymmetry, ptosis, excessive dermatochalasis, scarring and any alterations to facial anatomy, as a result of previous surgical interventions should be taken into consideration prior to injection. Injections at more frequent intervals/higher doses can increase the risk of antibody formation. Avoid administering different botulinum neurotoxins during the course of treatment with Azzalure. To be used for one single patient treatment only during a single session. There is a potential risk of localised muscle weakness or visual disturbances linked with the use of this medicinal product which may temporarily impair the ability to drive or operate machinery. Interactions: Concomitant treatment with aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like agents) may potentiate effect of botulinum toxin. Pregnancy, Lactation & Fertility: Not to be used during pregnancy or lactation. There are no clinical data from the use of Azzalure on fertility. There is no evidence of direct effect of Azzalure on fertility in animal studies. Side Effects: Most frequently occurring related reactions are headache and injection site reactions for glabellar lines and; headache, injection site reactions and eyelid oedema for lateral canthal lines. Generally treatment/injection technique related reactions occur within first week following injection and are transient. Undesirable effects may be related to the active substance, the injection procedure, or a combination of both. For glabellar lines: Very Common (≥ 1/10): Headache, Injection site reactions (e.g. erythema, oedema, irritation, rash, pruritus, paraesthesia, pain, discomfort, stinging and haematoma). Common (≥ 1/100 to < 1/10): Temporary facial paresis (due to temporary paresis of facial muscles proximal to injection sites, predominantly describes brow paresis), Asthenopia, Eyelid ptosis, Eyelid oedema, Lacrimation increase, Dry eye, Muscle twitching (twitching of muscles around the eyes). Uncommon (≥ 1/1,000 to <1/100): Dizziness, Visual impairment, Vision blurred, Diplopia, Pruritus, Rash, Hypersensitivity, Eye movement disorder. Rare (≥ 1/10,000 to < 1/1,000): Urticaria. For lateral canthal lines: Common (≥ 1/100 to < 1/10): Headache, Temporary facial paresis (due to temporary paresis of facial muscles proximal to injection sites), Eyelid ptosis, Eyelid oedema and Injection site disorders (e.g. haematoma, pruritus and oedema). Uncommon (≥ 1/1,000 to <1/100): Dry eye. Adverse reactions resulting from distribution of the effects of the toxin to sites remote from the site of injection have been very rarely reported with botulinum toxin (excessive muscle weakness, dysphagia, aspiration pneumonia with fatal outcome in some cases). Prescribers should consult the summary of product characteristics in relation to other side effects. Packaging Quantities & Cost: UK 1 Vial Pack (1 x 125u) £64.00 (RRP), 2 Vial Pack (2 x 125u) £128.00 (RRP), IRE 1 Vial Pack (1 x 125u) €93.50, 2 Vial Pack (2 x 125u) €187.05 (RRP) Marketing Authorisation Number: PL 06958/0031 (UK), PA 1613/001/001 (IRE) Legal Category: POM Further Information is Available From: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts. WD17 1DS, UK. Tel: +44 (0) 1923 208950 Fax: +44 (0) 1923 208998 Date of Revision: September 2018
Adverse events should be reported. For the UK, Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. For Ireland, Suspected adverse events can be reported via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. Adverse events should also be reported to Galderma (UK) Ltd.
good knowledge and understanding of the equipment, treatment protocols and methods for the device employed, which can usually be obtained from your device provider. Like many treatments in aesthetics, insurance is what determines whether or not you are able to perform cryotherapy treatments, and there are several providers available.
How cryotherapy works Cryotherapy is defined as the local or general use of low temperatures in medical therapy, and refers to the removal of skin lesions by freezing. The procedure works by cellular and vascular injury to the tissue.7 There are several methods for delivering cryotherapy, such as liquid nitrogen, those that employ vapourisation of a volatile liquid to create cooling, and others that use nitrous oxide. As my experience lies in liquid nitrogen, I will be discussing this approach. The advantage of liquid nitrogen cyrospray is that it reaches colder temperatures than other methods,8,9,10 which I find achieves superior results. However, the disadvantages are that it requires a large storage dewar and an appropriate safe storage space,11 while other methods are more ready to hand and economical for purchase. The clinic will also require regular deliveries of liquid nitrogen to utilise this approach. The treatment is usually delivered by a cryotherapy spray or probe that is connected to a reservoir of liquid nitrogen, which is at a temperature of -196°C. Using an open spray of liquid nitrogen creates an ice ball, the depth of which is roughly equal to the lateral spread.12 Much is known about the efficacy of liquid nitrogen,13,14 and guidelines for treatment are well established.15
What can be treated? As mentioned above, many skin conditions can be treated using cryotherapy. The types of benign skin lesions that are suitable for this treatment include actinic keratosis, solar lentigo, seborrheic keratosis, viral wart, molluscum contagiosum, and dermatofibroma.16 It should be noted that the efficacy of treatment depends on the condition; cryotherapy for solar lentigo is considered by some to be the treatment of choice, for example,17 whilst others suggest laser may be better.18 Other lesions such as keloid scars that have been treated with cryotherapy plus steroid injection have shown positive results.19 Some conditions are easier to treat through cryotherapy than others – for example, some cells such as melanocytes are easily damaged by cold, whereas others such as fibroblasts are very resistant to cold. There is a comprehensive list of lesions that can be safely treated with cryotherapy in Cutaneous Cryosurgery. 12
Treatment process As diagnosis involves comprehensive assessment and training, and differs for each condition, I will not be discussing this in detail. Once a diagnosis has been made, cryotherapy treatment is fairly simple. An informed consent must be obtained and the side effects of cryotherapy outlined. These are outlined in the British Association of Dermatologists’ Patient Information Leaflets, which I issue to my patients (Table 1).6 Once consent is obtained, it is useful to apply a topical anaesthetic cream such as EMLA and de-bulk the most hyperkeratotic lesions before treatment. This removes the excess lesion; I often break a tongue depressor by twisting it and scraping off the excess material or use a scalpel. There are a variety of ways to treat with liquid nitrogen and the kits supplied usually have different nozzle sizes. I find that it is useful to use the disposable ear cones that come with otoscopes as they can be cut to a lesion size to funnel the spray. The lesion is sprayed from about 1cm away until an ice ball forms around it, which should be maintained for the number of seconds required in the protocol, which are well-established and are different for each lesion. More information on these protocols can be found in Cutaneous Cyrosurgery. 21 Feathering is a method I use to blend the edges of the treatment area, which is
Immediate Cryotherapy side effects
Subsequent
Pain Although usually well-tolerated, if a deep freeze has been used, then cryotherapy can cause some discomfort and pain both during and after the treatment. Taking painkillers an hour before the anticipated treatments and for the following 24 hours may relieve discomfort. Scarring A scar will rarely form, and is more common if a deep freeze has been necessary. Hypertrophic/keloid scarring is rare, and appears as a founded, hard growth on the skin. These are more common in those with dark skin.
Swelling and redness This is a common immediate response to skin freezing and usually settles after two to three days. The area might ooze watery fluid for a short time following the procedure and treatment close to the eyes may result in prominent puffiness of the lower eyelids, which settles within days.
Blistering This is a common effect, but settles after a few days as the scab forms. Some patients are more prone to blistering than others and it does not necessarily mean the skin has been frozen too much. The blisters may occasionally become filled with blood and should only be punctured with a sterile needle if it is very uncomfortable/painful.
Infection This is uncommon, but can occur. Infection can result in increased pain and pus formation, which may require topical antiseptic or antibiotic therapy. Pigmentation changes The area at or around the treatment site may darken or lighten in colour, which is more common in dark-skinned individuals. This can be permanent, however usually improves with time.
Numbness This can occur if a superficial nerve is frozen. Normal feeling usually returns within a few months.
Unideal treatment outcome Treatment may not be effective, or the condition may recur.
