Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

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

Detailed Description
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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.

Official Title
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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.

Conditions
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Vulvar Lichen Sclerosus

Intervention / Treatment
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* Drug: Clobetasol propionate 0.05%
* Drug: Progesterone 8%


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks | Drug: Clobetasol propionate 0.05%<br>* Topical application, once daily about 2 g, during 12 weeks<br>|
| Experimental: 2<br>Progesterone 8%, topical application, once daily about 2 g, during 12 weeks | Drug: Progesterone 8%<br>* Topical application, once daily about 2 g, during 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported symptoms | The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore. | at baseline | 
| Quality of life | The patient will report quality of life on the SF12 questionnaire. | at baseline | 
| Adverse events | The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application. | at baseline | 
| Patient-reported symptoms | The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore. | 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. | 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. | at 18 weeks | 
| Patient-reported symptoms | The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore. | at 24 weeks | 
| Quality of life | The patient will report quality of life on the SF12 questionnaire. | at 12 weeks | 
| Quality of life | The patient will report quality of life on the SF12 questionnaire. | at 24 weeks | 
| Adverse events | The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application. | at 6 weeks | 
| Adverse events | The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application. | at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vulvar lichen sclerosus, progesterone, clobetasol, randomized controlled trial