NCT01126255

Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulvar Lichen Sclerosus

Interventions

Type	Name	Description
DRUG	Clobetasol propionate 0.05%	Topical application, once daily about 2 g, during 12 weeks
DRUG	Progesterone 8%	Topical application, once daily about 2 g, during 12 weeks

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2010-05-19
• Last updated: 2022-04-01

Locations

1 site across 1 country: Switzerland