Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01126255
Study type	Interventional
Source	University Hospital Inselspital, Berne
Contact
Status	Terminated
Phase	Phase 2
Start date	March 2011
Completion date	July 2014

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