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This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.
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.
The purpose of this study is to compare progesterone with conventional clobetasol propionate in a superiority trial.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Vulvar Lichen Sclerosus
Clobetasol propionate 0.05%, Progesterone 8%
Dep. of Obstetrics and Gynecology, Bern University Hospital
Not yet recruiting
University Hospital Inselspital, Berne
Published on BioPortfolio: 2014-08-27T03:13:35-0400
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.
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...
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...
The study aims to validate a vulvar scarring grading scale for lichen sclerosus (LS).
15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic specializing in vulvar disorders. This study consists of a 2 week screening period and a 12-week...
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 ...
To generate a list of items through international expert consensus consisting of both symptoms and clinical signs for inclusion in an adult vulvar lichen sclerosus severity scale.
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...
A rapid, simple to use and low-cost thin-layer chromatographic procedure in normal phase system with densitometric detection at 246 nm was carefully validated according to the International Conference...
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).
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.
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...
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...
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...