Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus
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.
|Vulvar Lichen Sclerosus||Drug: Tacrolimus cream Drug: Clobetasol cream||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double Blind Phase II Study Comparing Safety and Efficacy of Tacrolimus Versus Topical Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus.|
- To document the efficacy of Tacrolimus vs topical clobetasol propionate in the treatment of Vulvar Lichen Sclerosus by medical examinations and reporting of the symptoms. Cream is applied once a day for 3 months [ Time Frame: Comparison before the treatment and monthly for 3 months. ]
- Compared presence and severity of side effects of both groups. [ Time Frame: During the 3 months of treatment ]
- CBC, Glycemia, vitamine B 12 dosage, TSH (to find associated auto-immune diseases) [ Time Frame: At 1 to 3 months after starting the study, collected once. ]
|Study Start Date:||April 2006|
|Study Completion Date:||January 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
|Experimental: Tacrolimus cream||
Drug: Tacrolimus cream
0.5 g per day at bed time for 3 months or less.
Other Name: Prtopic
|Active Comparator: Clobetasol cream||
Drug: Clobetasol cream
0.5 gram each day at bed time during 3 months or less.
Other Name: Dermovate
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757874
|Montreal, Quebec, Canada, H3P 3N5|
|Principal Investigator:||Deana Funaro, Doctor||St. Justine's Hospital|