Trial | NCT00757874  Report issue

Title

Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus
A Double Blind Phase II Study Comparing Safety and Efficacy of Tacrolimus Versus Topical Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    56
Lichen Sclerosus is an inflammatory skin condition affecting mostly the genital area of persons of all ages, gender or race. The most frequent complaint is that of itchiness of the vulva but pain may also occur. Some women will experience no symptoms at all. However, it is important to treat this condition since it may increase and cause important scarring and deformity. In less than 5% of cases, cancer may develop.

Lichen Sclerosus is a chronic disease which can be controlled but not cured. Topical corticosteroids are the usual treatment for this condition. Though this treatment is generally well tolerated, some patients may not present a sufficient response or may develop mainly local and rarely systemic side effects. In this perspective, an alternative treatment would be beneficial.

Tacrolimus, a topical immunomodulator has been approved for the treatment of atopic eczema and has shown its efficacy in the treatment of vulvar lichen sclerosus in a limited number of patients. Tacrolimus acts as a non-steroidal anti-inflammatory agent (NSAI) without causing the usual side effects seen with the prolonged use of topical corticosteroids.

This study is designed to evaluate the safety and efficacy of tacrolimus in treating vulvar lichen sclerosus by comparing it with the standard topical corticosteroid treatment.
Study Started
Apr 30
2006
Primary Completion
Nov 30
2009
Study Completion
Jan 31
2010
Last Update
Sep 09
2015
Estimate

Drug Tacrolimus cream

0.5 g per day at bed time for 3 months or less.

  • Other names: Prtopic

Drug Clobetasol cream

0.5 gram each day at bed time during 3 months or less.

  • Other names: Dermovate

Tacrolimus cream Experimental

Clobetasol cream Active Comparator

Criteria 

Inclusion Criteria:

Female, 2 years or older
Medical diagnosis of vulvar lichen sclerosus
Received no treatment during the last 4 weeks

Exclusion Criteria:

Who have received topical steroids, tacrolimus or pimecrolimus during the 4 last weeks.
Who are immunocompromised
Who have history of intra-epithelial neoplasia or anogenital carcinoma
Who have active vulvar infections (herpes,condylomas,vaginitis)
Who are hypersensitive to tacrolimus, pimecrolimus or corticosteroids
Who have physical limitations that cause difficulty in applying the cream
Who wear diapers
Who present Hyperkeratotic Vulvar Lichen Sclerosus
No Results Posted