Clinical trial NCT01126255: Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Vulvar Lichen Sclerosus
Keywords: vulvar lichen sclerosus
progesterone
clobetasol
randomized controlled trial
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2010-05-19
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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)

Primary outcomes:
measure: Score of the characteristics of Lichen sclerosus based on vulvar efflorescences
timeFrame: at 12 weeks
Secondary outcomes:
measure: Patient-reported symptoms
timeFrame: at baseline
measure: Quality of life
timeFrame: at baseline
measure: Adverse events
timeFrame: at baseline
measure: Patient-reported symptoms
timeFrame: at 6 weeks
measure: Patient-reported symptoms
timeFrame: at 12 weeks
measure: Patient-reported symptoms
timeFrame: at 18 weeks
measure: Patient-reported symptoms
timeFrame: at 24 weeks
measure: Quality of life
timeFrame: at 12 weeks
measure: Quality of life
timeFrame: at 24 weeks
measure: Adverse events
timeFrame: at 6 weeks
measure: Adverse events
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. of Obstetrics and Gynecology, Bern University Hospital
Study officials:
name: Andreas Guenthert, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.