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Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

Information source: University Hospital Inselspital, Berne
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vulvar Lichen Sclerosus

Intervention: Clobetasol propionate 0.05% (Drug); Progesterone 8% (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: University Hospital Inselspital, Berne

Official(s) and/or principal investigator(s):
Andreas Guenthert, Prof. Dr. med., Principal Investigator

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Score of the characteristics of Lichen sclerosus based on vulvar efflorescences

Secondary outcome:

Patient-reported symptoms

Quality of life

Adverse events

Patient-reported symptoms

Patient-reported symptoms

Patient-reported symptoms

Patient-reported symptoms

Quality of life

Quality of life

Adverse events

Adverse events

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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)

Locations and Contacts

Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern 3010, Switzerland
Additional Information

Starting date: March 2011
Last updated: October 7, 2014

Page last updated: August 23, 2015

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