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Greater Manchester EUR Policy Statement on: Skin Resurfacing Techniques GM Ref: GM031 Version: 3.0 (18 September 2019)

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Page 1: Greater Manchester EUR Policy Statement on: Skin ... Policies/GM Skin Resurfacing Policy… · undesirable change, such as permanent skin lightening or scarring. The chemical peel

Greater Manchester EUR Policy Statement on:

Skin Resurfacing Techniques GM Ref: GM031 Version: 3.0 (18 September 2019)

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Commissioning Statement

Skin Resurfacing Techniques

Policy Exclusions (Alternative commissioning arrangements apply)

Sun damage leading to malignancy or possible malignancy are excluded from this policy and treatment may be undertaken in accordance with the appropriate clinical pathway. Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect).

Policy Inclusion Criteria

Skin resurfacing techniques are considered aesthetic procedures and are not routinely commissioned. Where clinicians feel there is a case for clinical exceptionality, funding will only be considered for cases of severe facial (above the clavicle) scarring. To support the decision-making process, non-identifiable photographs, preferably medical illustrations if available will be requested, but will not form the sole basis of the decision. It is not mandatory for photographs to be provided. NOTE:

Non-malignant sun damage is covered by the Greater Manchester EUR policy: GM013 Common Benign Skin Lesions policy

Treatment for post-traumatic scarring is not covered by this policy. Please see GM066 Surgical Revision of Scarring policy

Funding Mechanism

Cases of severe facial (above the clavicle) scarring: Individual funding request (exceptional case) approval: Requests must be submitted with all relevant supporting evidence.

Clinical Exceptionality

Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy

Best Practice Guidelines

All providers are expected to follow best practice guidelines (where available) in the management of these conditions.

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Contents Commissioning Statement ........................................................................................................................ 2

Policy Statement ...................................................................................................................................... 4

Equality & Equity Statement ..................................................................................................................... 4

Governance Arrangements ....................................................................................................................... 4

Aims and Objectives ................................................................................................................................. 4

Rationale behind the policy statement ...................................................................................................... 5

Treatment / Procedure .............................................................................................................................. 5

Epidemiology and Need ........................................................................................................................... 6

Adherence to NICE Guidance .................................................................................................................. 7

Audit Requirements .................................................................................................................................. 7

Date of Review ......................................................................................................................................... 7

Glossary ................................................................................................................................................... 7

References ............................................................................................................................................... 8

Governance Approvals ............................................................................................................................. 8

Appendix 1 – Evidence Review .............................................................................................................. 10

Appendix 2 – Diagnostic and Procedure Codes ...................................................................................... 15

Appendix 3 – Version History ................................................................................................................. 16

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Policy Statement The GM Effective Use of Resources (EUR) Policy Team, in conjunction with the GM EUR Steering Group, have developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission treatments/procedures in accordance with the criteria outlined in this document. In creating this policy the GM EUR Steering Group has reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester. This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR).

Equality & Equity Statement CCGs have a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act 2012. CCGs are committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, gender or sexual orientation. In carrying out its functions, CCGs will have due regard to the different needs of protected characteristic groups, in line with the Equality Act 2010. This document is compliant with the NHS Constitution and the Human Rights Act 1998. This applies to all activities for which they are responsible, including policy development, review and implementation. In developing policy the GM EUR Policy Team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group. The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their ‘starting point’ is considered to be further back than any other group. This will be reflected in CCGs evidencing taking ‘due regard’ for fair access to healthcare information, services and premises. An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact [email protected].

Governance Arrangements The Greater Manchester Joint Commissioning Board has given delegated authority to the Greater Manchester Directors of Commissioning and Directors of Finance to approve GM EUR treatment policies for implementation. Further details of the governance arrangements can be found in the GM EUR Operational Policy.

Aims and Objectives This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by:

reducing the variation in access to treatments/procedures.

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ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness.

reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester.

promoting the cost-effective use of healthcare resources.

Rationale behind the policy statement Skin resurfacing therapies are considered predominantly cosmetic therapies and are not without the risk of side effects. As a result of this, skin resurfacing therapies are not routinely commissioned by the NHS locally but may be provided for severe cases when the disfigurement to be treated falls into the categories described in section 4 of this policy, or where clinical exceptionality has been demonstrated.

Treatment / Procedure Skin resurfacing is essentially a controlled injury to the skin with the aim that, as the skin heals, it forms ‘good’ scar tissue to replace the previous ‘scarring’ however, the risk is that the skin forms ‘bad’ scar tissue again. Skin resurfacing techniques range from topical creams to laser therapy. They are increasingly popular in the private sector for the treatment of wrinkles and other skin damage. They are increasingly used to manage scarring from acne, trauma and skin infection e.g. chicken pox. Chemical Peels use differing formulas of chemicals to treat the skin. Mild chemicals (like glycolic acid) create very superficial changes, but more irritating chemicals (such as phenol) can cause more profound changes in the skin. As the potential for dramatic change increases, so does the potential risk of undesirable change, such as permanent skin lightening or scarring. The chemical peel solution is applied to the area to be treated. The surgeon decides how long to leave the solution on their face by observing the changes in the appearance of the skin. The different types of chemical peels vary according to their specific ingredients and their strength. The depth of their peeling action may also be determined by factors such as how long they remain on the skin and whether they are applied lightly or rubbed more vigorously onto the skin. Glycolic (AHA) Peel: Generally, the most superficial peels are those using alpha hydroxy acids (AHAs) such as glycolic acid. TCA Peel: A trichloracetic acid (TCA) peel is often used for the treatment of wrinkles, pigmentary changes and skin blemishes. Phenol Peel: A phenol peel is sometimes recommended for treating particularly rough and sun-damaged facial skin. It can correct pigmentary problems including blotchiness or age-related brown spots and may be used in the treatment of precancerous skin conditions. Dermabrasion creates an injury similar to a friction burn, it uses a small, rapidly spinning wheel with a roughened surface similar to fine-grained sandpaper to abrade the skin, removing its upper layers. This injury heals the same as a friction burn. This procedure is sometimes used for the treatment of facial scars such as those caused by acne and is often performed on the cheeks or the entire face. Laser skin resurfacing removes skin layer by layer with precision. The new skin cells that form during healing give the skin a tighter, younger looking surface. The procedure can be done alone or with other cosmetic surgeries on the face.

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There are two forms of laser resurfacing. In the first form, laser resurfacing creates a uniform injury to the skin, similar to deep chemical peel or dermabrasion. In the second form, the laser ‘drills’ tiny holes into deeper layers of your skin, also known as ‘fractional resurfacing’. In fractional resurfacing, the majority of the skin surface is not injured. The skin then tightens by ‘connecting the dots’ where the collagen contracts between the tiny laser holes. The benefit of fractional treatment is less surface injury. The risk is that there is a greater depth of injury and a risk of undesirable scarring. Potential risks of the procedure include:

Burns or other injuries from the laser's heat

Scarring

Changes in the skin's pigmentation, including areas of darker or lighter skin

Reactivating herpes simplex

Bacterial infection

Epidemiology and Need Wrinkling was more common in people with white skin (especially skin phototypes I and II). There are few reports of photodamage in black skin (phototypes V and VI). One study reported that the incidence of photodamage in European and North American populations with Fitzpatrick skin types I, II, and III is about 80%–90%.4

Acne is the most common skin disease of adolescence, affecting over 80% of teenagers (aged 13–18 years) at some point. Estimates of prevalence vary depending on study populations and the method of assessment used. Prevalence of acne in a community sample of 14- to 16-year-olds in the UK has been recorded as 50%.In a sample of adolescents from schools in New Zealand, acne was present in 91% of males and 79% of females, and in a similar population in Portugal the prevalence was 82%.It has been estimated that up to 30% of teenagers have acne of sufficient severity to require medical treatment. Acne was the presenting complaint in 3.1% of people aged 13 to 25 years attending primary care in a UK population. Overall incidence is similar in both men and women, and peaks at 17 years of age. The number of adults with acne, including people over 25 years, is increasing; the reasons for this increase are uncertain.5

The severity of acne scarring should be assessed using the table below and the grade included in the application. Table showing a grading system for post acne scarring:

Qualitative scarring grading system (adapted from G. J. Goodman and J. A. Baron, “Postacne scarring: a qualitative global scarring grading system,” Dermatologic Surgery, vol. 32, no. 12, pp. 1458–1466, 2006)

Grades of Post Acne Scarring

Level of disease

Clinical features

1 Macular These scars can be erythematous, hyper- or hypopigmented flat marks. They do not represent a problem of contour like other scar grades but of color.

2 Mild Mild atrophy or hypertrophy scars that may not be obvious at social distances of 50 cm or greater and may be covered adequately by makeup or the normal shadow of shaved beard hair in men or normal body hair if extrafacial.

3 Moderate Moderate atrophic or hypertrophic scarring that is obvious at social distances of 50 cm or greater and is not covered easily by makeup or the normal shadow of shaved beard hair in men or body hair if extrafacial, but is still able to be flattened by manual stretching

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of the skin (if atrophic).

4 Severe Severe atrophic or hypertrophic scarring that is evident at social distances greater than 50 cm and is not covered easily by makeup or the normal shadow of shaved beard hair in men or body hair if extrafacial and is not able to be flattened by manual stretching of the skin.

Adherence to NICE Guidance NICE have not currently issued guidance on this treatment.

Audit Requirements There is currently no national database. Service providers will be expected to collect and provide audit data on request.

Date of Review Five years from the date of the last review, unless new evidence or technology is available sooner. The evidence base for the policy will be reviewed and any recommendations within the policy will be checked against any new evidence. Any operational issues will also be considered at this time. All available additional data on outcomes will be included in the review and the policy updated accordingly. The policy will be continued, amended or withdrawn subject to the outcome of that review.

Glossary

Term Meaning

Acne Acne vulgaris is a common inflammatory pilosebaceous disease characterised by comedones; papules; pustules; inflamed nodules; superficial pus-filled cysts; and (in extreme cases) canalising and deep, inflamed, sometimes purulent sacs. Lesions are most common on the face, but the neck, chest, upper back, and shoulders may also be affected. Acne can cause scarring and considerable psychological distress. It is classified as mild, moderate, or severe.

Chicken Pox An infectious disease caused by a Herpes virus causing acutely itchy skin lesions which if scratched may cause deep scarring.

Controlled injury Damage inflicted to a tissue in a planned and controlled way

Glycolic (AHA) Peel A specific type of chemical applied to the skin as a mask which ‘peels’ away the damaged layers.

Herpes Simplex A type of virus

Malignant Unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invading nearby parts of the body.

Mild Acne Is defined as non-inflammatory lesions (comedones), a few inflammatory (papulopustular) lesions, or both.

Moderate Acne Is defined as more inflammatory lesions, occasional nodules, or both, and mild scarring.

Phenol peel A specific type of chemical applied to the skin as a mask which ‘peels’ away the damaged layers.

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Pigmentary Relating to the deposition of darkened patches in the skin

Post-traumatic scarring

Formation of scar tissues after damage to the skin from and external force

Rhinophyoma A large, bulbous, ruddy nose caused by granulomatous infiltration, commonly due to untreated rosacea.

Scar/Scarring A mark left on the skin or within body tissue where a wound, burn, or sore has not healed completely and fibrous connective tissue has developed.

Severe Acne Is defined as widespread inflammatory lesions, nodules, or both, and scarring, moderate acne that has not settled with 6 months of treatment, or acne of any ‘severity’ with serious psychological upset.

Trauma Physical injury due to external forces

Trichloracetic Acid (TCA) peel

A specific type of chemical applied to the skin as a mask which ‘peels’ away the damaged layers.

Tuberous Sclerosis A rare multi-system genetic disease that causes benign tumors to grow in the brain and on other vital organs such as the kidneys, heart, eyes, lungs, and skin.

References

1. GM EUR Operational Policy

2. GM013 Common Benign Skin Lesions policy

3. GM066 Surgical Revision of Scarring policy

4. Isotretinoin improves the appearance of photodamaged skin: results of a 36-week, multicenter, double-blind, placebo-controlled trial, Maddin S, Lauharanta J, Agache P, et al., J Int Med Res1992;20:381 –391.[PubMed]

5. BMJ best practice website : Acne vulgaris, Sarah Purdy; David de Berker

Governance Approvals

Name Date Approved

Greater Manchester Effective Use of Resources Steering Group 20/05/2015

Greater Manchester Chief Finance Officers / Greater Manchester Directors of Commissioning

11/08/2015

Greater Manchester Association Governing Group 15/09/2015

Bolton Clinical Commissioning Group 23/10/2015

Bury Clinical Commissioning Group 07/10/2015

Heywood, Middleton & Rochdale Clinical Commissioning Group 20/11/2015

Manchester Clinical Commissioning Group North: 21/10/2015 Central: 16/12/2015 South: 01/10/2015

Oldham Clinical Commissioning Group 15/09/2015

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Salford Clinical Commissioning Group 15/09/2015

Stockport Clinical Commissioning Group 23/09/2015

Tameside & Glossop Clinical Commissioning Group 25/10/2015

Trafford Clinical Commissioning Group 17/11/2015

Wigan Borough Clinical Commissioning Group 07/10/2015

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Appendix 1 – Evidence Review

Skin Resurfacing Techniques GM031

Search Strategy The following databases are routinely searched: NICE Clinical Guidance and full website search; NHS Evidence and NICE CKS; SIGN; Cochrane; York; and the relevant Royal College and any other relevant bespoke sites. A Medline / Open Athens search is undertaken where indicated and a general google search for key terms may also be undertaken. The results from these and any other sources are included in the table below. If nothing is found on a particular website it will not appear in the table below:

Database Result

NHS Evidence and NICE CKS

Cochrane reviews (see below)

Royal College of dermatologists guidelines on the use of PDT (not cited here as did not include scarring)

Cochrane Laser resurfacing for facial acne scars, Jordan R, Cummins CCL, Burls A, Seukeran DDC., Cochrane Database of Systematic Reviews 2000; Issue 3. Art. No.: CD001866. DOI: 10.1002/14651858.CD001866.

Interventions for photodamaged skin, Samuel M, Brooke R, Hollis S, Griffiths CEM., Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD001782. DOI: 10.1002/14651858.CD001782.pub2.

Interventions for acne scars, Abdel Hay R, Shalaby K, Zaher H, Hafez V, Chi CC, Dimitri S, Nabhan AF, Layton AM., Cochrane Database of Systematic Reviews 2016, Issue 4. Art. No.: CD011946. DOI: 10.1002/14651858.CD011946.pub2., (Added at review: Sep 2016)

BMJ Clinical Evidence BMJ Clinical Evidence Review: Wrinkles, Juan Jorge Manríquez, Karina Cataldo, Cristián Vera-Kellet, and Isidora Harz-Fresno, Web publication date: 22 December 2014 (based on February 2014 search), (Previous version replaced by updated version added at review: Sep 2016)

BMJ Best Practice Reference to BMJ clinical evidence review: Wrinkles (cited above)

General Search (Google) Provider websites and papers (already cited)

Medline / Open Athens Not done

Other BAAPS website: Information leaflet: Lasers in Plastic Surgery

Summary of the evidence There is limited evidence available for the effectiveness of these techniques which work by causing damage to the skin which should then heal in a more acceptable way. There is also a relatively high rate of side effects as a result of these treatments most notably erythema. High quality RCT studies are needed.

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The evidence

Levels of evidence

Level 1 Meta-analyses, systematic reviews of randomised controlled trials

Level 2 Randomised controlled trials

Level 3 Case-control or cohort studies

Level 4 Non-analytic studies e.g. case reports, case series

Level 5 Expert opinion

1. LEVEL 1: SYSTEMATIC REVIEW

Interventions for photodamaged skin, Samuel M, Brooke R, Hollis S, Griffiths CEM., Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD001782. DOI: 10.1002/14651858.CD001782.pub2.

Background: Photodamage describes skin changes such as fine and coarse wrinkles, roughness, freckles and pigmentation changes that occur as a result of prolonged exposure to the sun. Many treatments are available to reverse the damage, but it is unclear which work and at what cost in terms of unwanted side effects.

Objectives: To assess the effects of topically applied treatments, tablet treatments, laser and surgical procedures for photodamaged skin.

Search methods: We searched the Cochrane Central Register of Controlled Trials in The Cochrane Library, Issue 12002, MEDLINE(1966 -June 2002), EMBASE (1974-June 2002), Health Periodicals (1976-June 2002). We checked references of articles and communicated with authors and the pharmaceutical industry.

Selection criteria: Randomised controlled trials which compared drug or surgical interventions with no treatment, placebo or another drug, in adults with mild, moderate or severe photodamage of the face or forearms.

Data collection and analysis: Two reviewers independently extracted data and assessed trial quality.

Main results: Thirty studies of variable quality were included. Eight trials showed that topical tretinoin cream, in concentrate ions of 0.02% or higher, was superior to placebo for participants with mild to severe photodamage on the face and forearms (although losses to follow up were relatively high in most studies). For example, the relative risk of improvement for 0.05% tretinoin cream, compared to placebo (3 studies), at 24 weeks, was 1.73 (95% confidence interval 1.39 to 2.14). This effect was not seen for 0.001% topical tretinoin (1 study) or 0.01% (3 studies). A dose-response relationship was evident for both effectiveness and skin irritation.

One small within-patient study showed benefit from topical ascorbic acid compared with placebo.

Tazarotene (0.01% to 0.1%) and isotretinoin (0.1%) both showed significant improvement over placebo for moderate photodamage(one study each).

There is limited evidence (one trial), to show that the effectiveness of 0.05% tretinoin, is equivalent to the effects of 0.05% and 0.1% tazarotene.

One small study showed greater improvement in upper lip wrinkles with CO2 laser technique compared to Baker’s phenol chemical peel, at six months.

Three small RCTs comparing CO2 laser with dermabrasion found no difference in wrinkle score at four to six months, suggesting that both methods are equally efficacious, but more erythema was reported with the laser. The effectiveness of other interventions such as hydroxy acids and natural polysaccharides was not clear.

Authors’ conclusions: There is conclusive evidence that topical tretinoin improves the appearance of mild to moderate photodamage on the face and forearms, in the short-term. However erythema, scaling/dryness, burning/stinging and irritation may be experienced initially. There is limited evidence

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that tazarotene and isotretinoin benefit patients with moderate photodamage on the face: both are associated with skin irritation and erythema. The effectiveness of other interventions remains uncertain. 2. LEVEL 1: SYSTEMATIC REVIEW

Laser resurfacing for facial acne scars, Jordan R, Cummins CCL, Burls A, Seukeran DDC., Cochrane Database of Systematic Reviews 2000; Issue 3. Art. No.: CD001866. DOI: 10.1002/14651858.CD001866.

Background: Most people have acne at some stage during their life, with about one per cent being left with permanent acne scars. Recent laser techniques are thought to be more effective than chemical peels and dermabrasion.

Objectives: To assess the effects of laser resurfacing for treating facial acne scars.

Search methods: We searched MEDLINE (1966 to April 1999), EMBASE (1980 to April 1999), Science Citation Index (1981 to April 1999), the Cochrane Controlled Trials Register (April 1999), DARE (April 1999), INAHTA (April 1999), NHS HTA Internet site (April 1999). Dermatological Surgery (1995 to March 1999) and the British Journal of Dermatology (1995 to September 1999) were hand searched. We searched the reference lists of relevant articles and contacted experts and commercial laser manufacturers.

Selection criteria: Randomised controlled trials which compare different laser resurfacing techniques for treating patients with facial acne scars, or compare laser resurfacing with other resurfacing techniques or no treatment.

Data collection and analysis: Two reviewers independently selected studies, assessed the quality of studies and extracted data.

Main results: No randomised controlled trials where laser treatment was compared to either placebo or a different type of laser were found. Most of the 27 studies uncovered were poor quality case series with small numbers of acne-scarred patients.

Authors’ conclusions: The lack of good quality evidence does not enable any conclusions to be drawn about the effectiveness of lasers for treating atrophic or ice-pick acne scars. Well designed randomised controlled comparisons of carbon dioxide versus Erbium:YAG laser are urgently needed. This review does not cover acne rosacea, acne secondary to industrial occupations, and treatment of acne in people under 13 years of age. 3. LEVEL 4: EXPERT OPINION

BAAPS website: Information leaflet: Lasers in Plastic Surgery Lasers in Plastic Surgery

Who does it help: It treats the effect of sun damage and ageing of the face, thus it reduces fine wrinkles, uneven pigmentation and rough skin. It also slightly tightens the skin. It is moderately effective in treating facial scars as for instance shallow acne scars. Certain early skin cancers can be treated by CO2 Laser where the aesthetic result is particularly important. Other methods may give more certain cures.

Are there other options: Dermabrasion and chemical peels have been used for the same purpose for many years. A CO2 Laser is newer, more expensive and possibly more precise and effective.

What is involved: Small areas can be treated under local anaesthetic cream (EMLA, Ametop) or local anaesthetic injections. Intravenous sedation can be given by an Anaesthetist to supplement this, or if the patient prefers, a full general anaesthetic. This would be usual if the whole face is treated. After treatment the skin is raw and may be covered with ointment or a dressing. Healing takes 7 to 10 days leaving the new skin red. Camouflage make-up is helpful in covering this. The redness usually fades after two to six months during which time sunshine should be avoided. Sun exposure increases the risk of the development of dark pigmentation. This is more common in patients with olive, brown or black skin.

What are the risks: Slight changes in pigmentation can occur. Any darkening can be treated but will tend to resolve spontaneously. Long term lightening of pigmentation is also a possibility. Scarring is rare with normal skin. The risk is greatest in patients known to produce keloids, who have been treated with radiotherapy in the area or have had a recent course of Roaccutane. Cold sores (herpes) can be

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reactivated. Patients with this tendency are given preventative treatment. Risks will be reduced by choosing a surgeon who is an accredited plastic surgeon trained in laser surgery. Members of BAAPS are all on the General Medical Council's Specialist Register in Plastic Surgery. 4. LEVEL 1: SYSTEMATIC REVIEW (COCHRANE)

Interventions for acne scars, Abdel Hay R, Shalaby K, Zaher H, Hafez V, Chi CC, Dimitri S, Nabhan AF, Layton AM., Cochrane Database of Systematic Reviews 2016, Issue 4. Art. No.: CD011946. DOI: 10.1002/14651858.CD011946.pub2.

TREATMENT FOR ACNE SCARS

Review question: Which treatments are effective for acne scars?

Background: Acne scars may have a damaging effect on a person’s physical, mental, and social well-being. Although a wide range of treatments are used, there is a lack of high-quality evidence on which are the most effective for acne scars.

This review aimed to better inform patients and healthcare providers about the most effective and safe methods to manage this problem.

We have examined treatments for atrophic scars (depressions in the skin surface) and hypertrophic scars (lumpy scars that stick out from the skin surface) in acne but have concentrated on facial atrophic scarring. Our main outcomes of interest were participant-reported scar improvement and any adverse effects serious enough to cause participants to withdraw from the study.

Study characteristics: We include 24 randomised controlled trials (RCTs) with 789 people with acne scars (from searches up to November 2015). Twenty one RCTs (706 people) enrolled both men and women, three RCTs (75 people) enrolled only women and one RCT (eight people) enrolled only men. Most of the studies we included (21 RCTs with 744 people) enrolled people with atrophic acne scars. One RCT enrolled 20 individuals with mixed atrophic and hypertrophic acne scars.

Key results: There is insufficient evidence from trials to support fractional laser for treatment of acne. However, this management approach is adopted by some in clinical practice for the treatment of acne scarring.

For our outcome ’Participant-reported scar improvement’ fractional laser was more effective in producing scar improvement change than non-fractional non-ablative laser. Fractional radiofrequency showed similar scar improvement to fractional laser. Chemical peeling showed similar scar improvement to both fractional laser and skin needling. Combined chemical peeling with skin needling showed similar scar improvement to fractional laser and to deep chemical peeling. Injectable fillers provided better scar improvement compared to placebo.

Our outcome ‘Serious adverse effects’ was reported in one study, showing that chemical peeling was not tolerable in 16%of those taking part. Other outcomes, ‘Participant-reported’ and ’Investigator-assessed’ adverse events in the short term (less than 24 weeks), were more or less acceptable by those taking part and by investigators and did not reveal a big difference between the studied interventions.

Four out of six of our comparisons were completely inconclusive and they were of very low-quality evidence. There is a lack of studies that establish efficacy of treatments compared to placebo or sham interventions, and it is possible that finding no evidence of difference between two active treatments could mean that neither is very useful.

We did not identify any trials that examined treatment for acne scars on the back.

The results of this review do not support the first-line use of any intervention in the treatment of acne scars, and no studies provided evidence to confirm that any short-term benefit will translate to long-term effects.

Quality of the evidence: We rated the quality of the evidence for several outcomes as very low to moderate. The lower quality evidence for treatments was mostly because there were few people in the studies, making the results less precise, and there was a lack of blinding (people knew the treatment they were receiving).

Future studies should consider adopting patient-reported outcomes as a primary measure. There should be a set of core outcome measures reported in all RCTs for treating acne scars, and outcomes should be evaluated several months after the treatment has been done. Lack of reporting of serious side effects was one of the research gaps found in this review.

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5. LEVEL 1: SYSTEMATIC REVIEW BMJ Clinical Evidence Review: Wrinkles, Juan Jorge Manríquez, Karina Cataldo, Cristián Vera-Kellet, and Isidora Harz-Fresno, Web publication date: 22 December 2014 (based on February 2014 search)

ABSTRACT

Introduction: Skin disorders associated with photodamage from ultraviolet light include wrinkles, hyperpigmentation, tactile roughness, and telangiectasia, and are more common in people with white skin compared with other skin types. Wrinkles are also associated with ageing, hormonal status, smoking, and intercurrent disease.

Methods and Outcomes: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for skin wrinkles? We searched: Medline, Embase, The Cochrane Library, and other important databases up to February 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review).We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Results: We found 33 studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions: In this systematic review we present information relating to the effectiveness and safety of the following interventions: botulinum toxin injection (e.g., botulinum toxin type A and type B), carbon dioxide laser, chemical peel (including alpha and beta hydroxyl acids), dermabrasion, isotretinoin, tazarotene, tretinoin, and variable pulse erbium:YAG laser.

Key Points

Exposure to ultraviolet light may be associated with photodamage to the skin. Guidelines suggest that avoiding direct sunlight, either by staying indoors or in the shade, or by wearing protective clothing, is the most effective measure for reducing exposure to ultraviolet light.

Botulinum toxin injection (given in a single session) seems to be more effective than placebo at improving wrinkles at up to 120 days. We found no RCTs comparing repeated injections of botulinum toxin versus placebo over a long period of time.

Topical tretinoin may improve fine wrinkles when applied daily, compared with vehicle cream, in people with mild to severe photodamage, but its effect on coarse wrinkles is unclear. Topical tretinoin may cause itching, burning, erythema, and skin peeling.

Isotretinoin cream applied daily may improve fine and coarse wrinkles compared with vehicle cream in people with mild to severe photodamage, but may cause severe irritation of the face.

Tazarotene applied daily may improve the appearance of fine wrinkles compared with placebo/vehicle cream. However, it can cause burning of the skin. We don't know whether tazarotene is more effective than tretinoin at improving fine and coarse wrinkles in people with moderate photodamage, as studies have given inconclusive results.

We don't know whether chemical peel (including alpha and beta hydroxyl acids) is beneficial.

We don't know whether dermabrasion is more effective at improving wrinkles compared with carbon dioxide laser treatment, as studies have given inconclusive results, but adverse effects are common with both treatments, especially erythema.

We don't know whether variable pulse erbium:YAG laser treatment improves wrinkles, as few studies were found.

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Appendix 2 – Diagnostic and Procedure Codes

Skin Resurfacing Techniques GM031

(All codes have been verified by Mersey Internal Audit’s Clinical Coding Academy)

GM031 - Skin Resurfacing Techniques Policy

Laser destruction of lesion of skin NEC S09.2

Other specified photodestruction of lesion of skin S09.8

Chemical peeling of lesion of skin of head or neck S10.3

Chemical peeling of lesion of skin NEC S11.3

Electrolysis to lesion of skin NES S11.4

Dermabrasion of skin of head or neck S60.1

Dermabrasion of skin NEC S60.2

With the following ICD-10 diagnosis code(s):

Other plastic surgery for unacceptable cosmetic appearance Z41.1

ICD-10 Diagnostic codes (Exceptions):

Shave skin of nose E09.4

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Appendix 3 – Version History

Skin Resurfacing Techniques GM031

The latest version of this policy can be found here: GM Skin Resurfacing Techniques policy

Version Date Summary of Changes

0.1 04/11/2014 Initial draft

0.2 25/11/2014 Amendments made by the Greater Manchester EUR Steering Group on 19/11/2014:

Criteria for Commissioning removed and replaced with statement that the procedure is considered aesthetic and not routinely commissioned.

A guide as to what is requested if exceptionality was being claimed has been added, including non-compulsory photographs.

Draft policy approved for consultation following the above amendments.

1.0 25/6/2015 Amendments made by the Greater Manchester EUR Steering Group on the 20/05/2015:

Section 4 - Commissioning Criteria: Paragraph added under Policy Exclusions ‘This policy does not apply to any service which includes skin resurfacing as part of a locally agreed pathway or as part of a local contract / service level agreement’.

Table showing a grading system for post acne scarring added.

Under Section 9 - Funding Mechanism the following paragraph has been added ‘Funding for treatment of severe facial (above the clavicle) scarring may be made available on an individual patient basis, and prior approval should be sought from the North West Commissioning Support Unit EUR Team’.

Following the above amendments the policy was approved by the Greater Manchester EUR Steering Group.

1.1 06/04/2016 List of diagnostic and procedure codes in relation to this policy added as Appendix 2.

Policy changed to Greater Manchester Shared Services template and references to North West Commissioning Support Unit changed to Greater Manchester Shared Services.

Wording for date of review amended to read ‘One year from the date of approval by Greater Manchester Association Governing Group thereafter at a date agreed by the Greater Manchester EUR Steering Group (unless stated this will be every 2 years)’ on ‘Policy Statement’ and section ‘13. Date of Review’.

2.0 21/09/2016 The policy was reviewed in August 2016 and two new papers were found, an updated version of a review and a new review, however these did not affect the existing policy. Following GM EUR Steering Group on 21 September 2016 it was agreed that no changes would be made to main body of policy and the following updates be made:

Review date added to cover page and ‘Policy Statement’

The ‘Date of Review’ on ‘Policy Statement’ and in body of report changed to ‘Three years from the date of last review unless new evidence warrants earlier review’

‘Appendix 1: Evidence Review’ updated to include the 2 new papers found

2.1 06/06/2018 Policy moved to new format and some wording rearranged and clarified.

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Appendix 2 o Added OPCS4 codes S09.8 Other specified photodestruction of lesion of

skin & S11.4 Electrolysis to lesion of skin NEC. o Removed OPCS-4 code S09.1 - Laser destruction of lesion of skin of

head and neck o Added E09.4 Shave skin of nose to policy exclusions.

2.2 28/01/2019 Branding changed to reflect change of service from Greater Manchester Shared Services to Greater Manchester Health and Care Commissioning.

Links updated as documents have all moved to a new EUR web address.

Commissioning Statement: o ‘(Alternative commissioning arrangements apply)’ added after Policy

Exclusions o ‘Best Practice Guideline’ section added

2.3 01/08/2019 Clinical Exceptionality Section updated to read: Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy

3.0 18/09/2019 The GM EUR Steering Group reviewed the policy. The usual evidence review was carried out in August 2019. No new systematic reviews or reviews of effectiveness were found. It was agreed therefore that no changes were necessary to the policy. Policy to be reviewed again in five years unless new evidence warrants earlier review.