Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

Efficacy of a Topic Therapy With Progesterone Compared to the Conventional Therapy With Clobetasol Propionate in Patients With Vulvar Lichen Sclerosus. A Double Blind, Randomized Phase II Pilot Study.

This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.

Background A total of 62 female patients with first diagnosis of lichen sclerosus will be treated daily with either topical progesterone 8% or clobetasol propionate 0.05% for 12 weeks. Response to the treatment will be evaluated by macroscopic description of the dermatologic phenotype by using a specific lichen sclerosus score and photography-documentation. The symptoms and quality of life of the patients will be evaluated by standardized questionnaires. Additionally, tissue samples will be taken before and again after 12 weeks of treatment to evaluate the response status. Objective The purpose of this study is to compare progesterone with conventional clobetasol propionate in a superiority trial. Methods Prospective, randomized, controlled, superiority phase II pilot trial. Patients will be randomized 1:1 to either progesterone or clobetasol propionate, with patients, physicians, assessors and analysts being blinded.

The severity of the Lichen sclerosus will be assessed by a metric score, which is based on 6 items (abrasion, hyperkeratosis, rhagades, synechia, sclerosis, atrophy of labia/clitoris) consisting of three levels (0=no signs, 1=few signs, 2=pronounced signs).

The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.

The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.

The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore.

The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore.

The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.

The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.

The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.

The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.

Inclusion Criteria: Signed informed consent Consent to biopsy at start and end of therapy Suspicion of Lichen sclerosus Pre-menopausal Age ≥18 years Exclusion Criteria Prior surgery at the vulva, with exception of episiotomy Pregnancy Signs of infection with human papilloma virus at the vulva Vulvar intraepithelial neoplasia (VIN) Known generalised autoimmune disease Lichen sclerosus since childhood Prior therapy with topic clobetasol propionate or other immunosuppressives (tacrolimus or pimecrolimus) at the vulva Atopic diathesis and/or contact allergy Systemic immunosuppressive therapy Genital infection within the last four weeks (eg., condyloma acuminata, candidiasis)

Gunthert AR, Limacher A, Beltraminelli H, Krause E, Mueller MD, Trelle S, Bobos P, Juni P. Efficacy of topical progesterone versus topical clobetasol propionate in patients with vulvar Lichen sclerosus - A double-blind randomized phase II pilot study. Eur J Obstet Gynecol Reprod Biol. 2022 May;272:88-95. doi: 10.1016/j.ejogrb.2022.03.020. Epub 2022 Mar 10.