Advertisement

Topics

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

Clinical Trials [466 Associated Clinical Trials listed on BioPortfolio]

Clobetasol Proprionate Versus Radiofrequency CO2 Laser for the Treatment of Lichen

This study is being done to compare the effects, good and bad, of radiofrequency laser treatment and clobetasol proprionate .05% ointment on vulvar lichen sclerosus.

Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus

Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cau...

The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients

This explorative investigation will assess the adhesion and tolerability of the Rivelin® plain patch when applied directly on lesions in subjects with Vulvar Lichen Sclerosus (VLS).

Vulvar Lichen Sclerosus: Comparison Between Clobetasol Propionate, Photodynamic Therapy and Low-Intensity Laser

Vulvar lichen sclerosus (VLS) is a lymphocyte-mediated disease of unknown etiology that can cause intense itching as well stenosis, hindering the evacuation and urination. It can also limi...

Biomarkers of Lichen Sclerosus

Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cau...

PubMed Articles [581 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.

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...

Fact or Fiction? Adipose-Derived Stem Cells and Platelet-Rich Plasma for the Treatment of Vulvar Lichen Sclerosus.

The aim of the study was to summarize and review the evidence for the efficacy and safety of adipose-derived stem cells (ADSCs) and platelet-rich plasma (PRP) for the treatment of vulvar lichen sclero...

Mucinous Metaplasia of the Vulva in Zoon Vulvitis and Lichen Sclerosus et Atrophicus. Description of 3 Additional Cases of a Rarely Reported Histopathologic Finding.

Mucinous metaplasia of the vulva (MMV) is a histopathologic finding that has been reported previously in only 3 patients and needs to be distinguished from vulvar extramammary Paget disease. We report...

Cushing syndrome induced by topical corticosteroids for the treatment of lichen sclerosus.

Lichen sclerosus is a chronic inflammatory dermatological condition with a predilection for the anogenital area.

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.

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.

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

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.

More From BioPortfolio on "Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Prostate Cancer
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...


Searches Linking to this Trial