Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

Vulvar Lichen Sclerosus Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01126255
• Other study ID #: 213/08
• Status: Terminated
• Phase: Phase 2
• Start date: March 2011
• Est. completion date: July 2014

Study information

• Verified date: March 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lichen Sclerosus et Atrophicus
• Vulvar Lichen Sclerosus

Intervention

Drug:
• Clobetasol propionate 0.05%
Topical application, once daily about 2 g, during 12 weeks
• Progesterone 8%
Topical application, once daily about 2 g, during 12 weeks

Locations

Country	Name	City	State
Switzerland	Dep. of Obstetrics and Gynecology, Bern University Hospital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Günthert AR, Limacher A, Beltraminelli H, Krause E, Mueller MD, Trelle S, Bobos P, Jüni P. Efficacy of topical progesterone versus topical clobetasol propionate in patients with vulvar Lichen sclerosus - A double-blind randomized phase II pilot study. Eur — View Citation

Outcome

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