Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

Insel Gruppe AG, University Hospital Bern

Status and phase: Terminated; Phase 2

Conditions: Vulvar Lichen Sclerosus

Treatments: Drug: Progesterone 8%; Drug: Clobetasol propionate 0.05%

Study type: Interventional

Funder types: Other

Identifiers

NCT01126255

213/08

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups

1

Active Comparator group

Description:

Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks

Treatment:

Drug: Clobetasol propionate 0.05%

2

Experimental group

Description:

Progesterone 8%, topical application, once daily about 2 g, during 12 weeks

Treatment:

Drug: Progesterone 8%