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Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

2014-08-27 03:13:35 | BioPortfolio

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Vulvar Lichen Sclerosus

Intervention

Clobetasol propionate 0.05%, Progesterone 8%

Location

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

Status

Not yet recruiting

Source

University Hospital Inselspital, Berne

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:35-0400

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PubMed Articles [591 Associated PubMed Articles listed on BioPortfolio]

Association of Retinoic Acid Receptor β Gene With Onset and Progression of Lichen Sclerosus-Associated Vulvar Squamous Cell Carcinoma.

Molecular alterations in lichen sclerosus-associated vulvar squamous cell carcinoma (LS-VSCC) are largely unknown.

Photodynamic Therapy for Vulvar Lichen Sclerosus-A Systematic Review.

Lichen sclerosus (LS) is a disease affecting mostly genital and perianal areas. Photodynamic therapy (PDT) has gained interest during the past years. The present study accumulates current evidence on ...

Vulvar Neoplasms in 275 Women With Genital Lichen Sclerosus and Impact of Treatment: A Retrospective Chart Review.

Lichen sclerosus (LS) is a chronic inflammatory disease most commonly affecting the genital area of women. LS-associated vulvar neoplasms are known to occur (1). Treatment of LS is thought to possibly...

Randomized, placebo-controlled, double-blind trial of clobetasol propionate 0.05% in the treatment of oral lichen planus.

To perform a randomized, placebo-controlled, double-blind study, with a follow-up period of 6 months, for the use of topical clobetasol in cases of symptomatic oral lichen planus (OLP).

Lichen sclerosus in pregnancy: A review of 33 cases.

Vulval lichen sclerosus (VLS) is a chronic inflammatory skin condition affecting the anogenital area in women. Serious long-term consequences of VLS include the risk of developing squamous cell carcin...

Medical and Biotech [MESH] Definitions

Atrophy and shriveling of the SKIN of the VULVA that is characterized by the whitish LICHEN SCLEROSUS appearance, inflammation, and PRURITUS.

A chronic inflammatory mucocutaneous disease usually affecting the female genitalia (VULVAR LICHEN SCLEROSUS) and BALANITIS XEROTICA OBLITERANS in males. It is also called white spot disease and Csillag's disease.

An ester of TESTOSTERONE with a propionate substitution at the 17-beta position.

Specific proteins found in or on cells of progesterone target tissues that specifically combine with progesterone. The cytosol progesterone-receptor complex then associates with the nucleic acids to initiate protein synthesis. There are two kinds of progesterone receptors, A and B. Both are induced by estrogen and have short half-lives.

Steroidal compounds related to PROGESTERONE, the major mammalian progestational hormone. Progesterone congeners include important progesterone precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with progestational activities.

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