NCT00757874

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Deana Funaro · Academic / Other
• Sex: Female
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Vulvar Lichen Sclerosus

Interventions

Type	Name	Description
DRUG	Tacrolimus cream	0.5 g per day at bed time for 3 months or less.
DRUG	Clobetasol cream	0.5 gram each day at bed time during 3 months or less.

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-11-01
• Completion: 2010-01-01
• First posted: 2008-09-23
• Last updated: 2015-09-09

Locations

1 site across 1 country: Canada