Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

Phase 2TerminatedNCT01126255

Insel Gruppe AG, University Hospital Bern37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Vulvar Lichen Sclerosus

Interventions

Clobetasol propionate 0.05%DRUG

Topical application, once daily about 2 g, during 12 weeks

Progesterone 8%DRUG

Topical application, once daily about 2 g, during 12 weeks

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Dep. of Obstetrics and Gynecology, Bern University Hospital

Bern, Switzerland

Outcomes

Primary Outcomes

Score of the characteristics of Lichen sclerosus based on vulvar efflorescences

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).

Time frame: at 12 weeks

Secondary Outcomes

Patient-reported symptoms

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

Time frame: at baseline

Quality of life

The patient will report quality of life on the SF12 questionnaire.

Time frame: at baseline

Adverse events

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

Time frame: at baseline

Patient-reported symptoms

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

Time frame: at 6 weeks

Patient-reported symptoms

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

Time frame: at 12 weeks

Patient-reported symptoms

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

Time frame: at 18 weeks

Data from ClinicalTrials.gov

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