Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

Phase 2

Terminated

• Conditions: Vulvar Lichen Sclerosus
• Interventions: Drug: Clobetasol propionate 0.05%; Drug: Progesterone 8%

• Registration Number: NCT01126255
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-05-07
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-19
• Study Start: 2011-03
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 37

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Clobetasol propionate 0.05%	Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks
2	Progesterone 8%	Progesterone 8%, topical application, once daily about 2 g, during 12 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse events	at 12 weeks	The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.
Quality of life	at 24 weeks	The patient will report quality of life on the SF12 questionnaire.
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.

Trial Locations

Locations (1)

Dep. of Obstetrics and Gynecology, Bern University Hospital; 🇨🇭 Bern, Switzerland