Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus
Information source: University Hospital Inselspital, Berne
Information obtained from ClinicalTrials.gov on February 07, 2013
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: Recruiting
Sponsored by: University Hospital Inselspital, Berne Official(s) and/or principal investigator(s):
Andreas Guenthert, PD Dr. med., Principal Investigator
Overall contact:
Andreas Guenthert, PD Dr. med., Phone: +41 31 632 12 01, Email: andreas.guenthert@insel.ch
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 symptomsQuality 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
Andreas Guenthert, PD Dr. med., Phone: +41 31 632 12 01, Email: andreas.guenthert@insel.ch
Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern 3010, Switzerland; Recruiting
Andreas Guenthert, PD Dr. med., Phone: +41 31 632 12 01, Email: andreas.guenthert@insel.ch
Michel Mueller, Prof. Dr. med., Phone: +41 31 632 12 01, Email: michel.mueller@insel.ch
Andreas Guenthert, PD Dr. med., Principal Investigator
Michel Mueller, Prof. Dr. med., Sub-Investigator
Thomas Hunziker, Prof. Dr. med., Sub-Investigator
Elke Krause, Dr. med., Sub-Investigator
N Ballabio, Dr.med, Sub-Investigator
Additional Information
Starting date: March 2011
Last updated: November 23, 2012
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