Question: What is the management of lichen sclerosus which is resistant to treatment with Dermovate, after repeating biopsies confirming the initial diagnosis?
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Answer: The 2007 UK National Guideline on the Management of Vulval Conditions (1) from the Clinical Effectiveness Group, British Association Sexual Health and HIV includes the following alternatives to treatment with clobetasol proprionate for vulvar lichen sclerosus:
“Alternative regimens
• A very potent topical steroid with antibacterial and antifungal e.g. Dermovate NN (if available) or an additional preparation that combats secondary infection (such as Nystaform), may be appropriate if secondary infection is a concern.
• Surgery – For the treatment of coexistent VIN / SCC or fusion. Disease tends to recur around the scar.
Research findings and unlicensed treatments
• Topical calcineurin inhibitors. This is not a licensed indication and long-term safety and efficacy is not established.
Tacrolimus 0.1% has been shown to be effective when used for 16 to 24 weeks . This study, which included males and females and genital and extragenital lichen sclerosus, showed that 77% of evaluable patients responded to treatment with 43% showing a complete response (absence of symptoms and skin findings excepting induration and atrophy) at 24 weeks. The follow up period was 18 months and whilst no patient was shown to have skin malignancy or dysplastic change the long-term risks need to be studied in view of concerns about the possibility of topical immunosuppression increasing susceptibility of malignancy. A study of the related agent, pimecrolimus, showed that 42% of patients were in ‘complete remission’ after 6 months application Local irritancy was the most common side effect with both tacrolimus and pimecrolimus but usually improved after the initial period of use.
• Oral retinoids, e.g. acitretin – these may be effective in severe recalcitrant disease but should only be given by a specialist such as a dermatologist, experienced in the use of these agents.
• UVA1 phototherapy has been reported as successful in a small number of cases.”
The British Association of Dermatologists published a guideline on lichen sclerosus in 2002 (2), and this includes a section on treatment failure:
“If treatment with topical corticosteroids fails to bring LS under control then it is important to consider the following:
1 Non-compliance. Sometimes patients may be alarmed at the warnings on the package insert warning against the use of a topical corticosteroid in the anogenital area and they will then not use the preparation. Also, very elderly patients disabled with poor eyesight and limited mobility may not be able to apply the medication appropriately.
2 Is the diagnosis correct, or is there an added problem such as the development of a contact allergy to the medication or is there another superimposed condition, e.g. secondary candidiasis, intraepithelial neoplasia, malignancy, psoriasis or mucous membrane pemphigoid?
3 Is the LS in fact treated, but the patient is still symptomatic because they have developed a secondary sensory problem, dysaesthetic vulvodynia or are experiencing problems with intercourse that they may feel too shy to discuss?
4 Is the problem mechanical due to scarring, e.g. severe phimosis or meatal stenosis in males, in which case surgery may be indicated?”
(Evidence level IV)
References:
1. 2007 UK National Guideline on the Management of Vulval Conditions / Clinical Effectiveness Group, British Association Sexual Health and HIV
2. Neill SM, Tatnall FM, Cox NH; British Association of Dermatologists. Guidelines for the management of lichen sclerosus. Br J Dermatol. 2002 Oct;147(4):640-9.
Search date: March 2009
Classification of evidence levels
Ia Evidence obtained from meta-analysis of randomised controlled trials.
Ib Evidence obtained from at least one randomised controlled trial.
IIa Evidence obtained from at least one well-designed controlled study without randomisation.
IIb Evidence obtained from at least one other type of well-designed quasi-experimental study.
III Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case studies.
IV Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities.
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