Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

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.

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

Study Overview

• Status: Terminated
• Conditions: Vulvar Lichen Sclerosus
• Intervention / Treatment: Drug: Clobetasol propionate 0.05%; Drug: Progesterone 8%

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks	Drug: 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	Drug: Progesterone 8%; Topical application, once daily about 2 g, during 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of the characteristics of Lichen sclerosus based on vulvar efflorescences	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).	at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported symptoms	The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.	at baseline
Quality of life	The patient will report quality of life on the SF12 questionnaire.	at baseline
Adverse events	The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.	at baseline
Patient-reported symptoms	The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore.	at 6 weeks
Patient-reported symptoms	The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore.	at 12 weeks
Patient-reported symptoms	The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.	at 18 weeks
Patient-reported symptoms	The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.	at 24 weeks
Quality of life	The patient will report quality of life on the SF12 questionnaire.	at 12 weeks
Quality of life	The patient will report quality of life on the SF12 questionnaire.	at 24 weeks
Adverse events	The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.	at 6 weeks
Adverse events	The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.	at 12 weeks

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: University of Bern
• Investigators: Principal Investigator: Andreas Guenthert, Prof. Dr. med.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (Estimate): May 19, 2010

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: randomized controlled trial; clobetasol; progesterone; vulvar lichen sclerosus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Vulvar Diseases; Lichenoid Eruptions; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone; Clobetasol
• Other Study ID Numbers: 213/08