Clinical Trial: Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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, Ran

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

Detailed Summary:

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.


Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome: Score of the characteristics of Lichen sclerosus based on vulvar efflorescences [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University Hospital Inselspital, Berne

Dates:
Date Received: May 7, 2010
Date Started: March 2011
Date Completion:
Last Updated: October 7, 2014
Last Verified: October 2014