Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2014

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks
  • Experimental: 2
    • Progesterone 8%, topical application, once daily about 2 g, during 12 weeks

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Insel Gruppe AG, University Hospital Bern
  • Collaborator
    • University of Bern
  • Provider of Information About this Clinical Study
    • PD Dr. med. A. Guenthert, Dep. of Obstetrics and Gynecology, Bern University Hospital
  • Overall Official(s)
    • Andreas Guenthert, Prof. Dr. med., Principal Investigator,

Citations Reporting on Results

Gunthert AR, Limacher A, Beltraminelli H, Krause E, Mueller MD, Trelle S, Bobos P, Juni P. Efficacy of topical progesterone versus topical clobetasol propionate in patients with vulvar Lichen sclerosus – A double-blind randomized phase II pilot study. Eur J Obstet Gynecol Reprod Biol. 2022 May;272:88-95. doi: 10.1016/j.ejogrb.2022.03.020. Epub 2022 Mar 10.

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