Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Terminated

CT.gov ID

NCT01126255

Collaborator

University of Bern (Other)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vulvar Lichen Sclerosus	Drug: Clobetasol propionate 0.05% Drug: Progesterone 8%	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks	Drug: Clobetasol propionate 0.05% Topical application, once daily about 2 g, during 12 weeks
Experimental: 2 Progesterone 8%, topical application, once daily about 2 g, during 12 weeks	Drug: Progesterone 8% Topical application, once daily about 2 g, during 12 weeks

Arm

Intervention/Treatment

Active Comparator: 1

Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks

Drug: Clobetasol propionate 0.05%

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

Experimental: 2

Progesterone 8%, topical application, once daily about 2 g, during 12 weeks

Drug: Progesterone 8%

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

Outcome Measures

Primary Outcome Measures

Score of the characteristics of Lichen sclerosus based on vulvar efflorescences [at 12 weeks]
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).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)