Clinical Trial: Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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.

Brief 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.


Detailed Summary:
Sponsor: Deana Funaro

Current Primary Outcome: 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. ]

Original Primary Outcome: To document the efficacy of Tacrolimus vs topical corticosteroids in the treatment of Vulvar Lichen Sclerosis by medical examinations and reporting of the symptoms (Comparison before the treatment and at the end of treatment). [ Time Frame: Cream is applied once a day for 3 months ]

Current Secondary Outcome:

  • 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. ]


Original Secondary Outcome:

  • 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 immune associated disease) [ Time Frame: Once during the study ]


Information By: St. Justine's Hospital

Dates:
Date Received: September 22, 2008
Date Started: April 2006
Date Completion:
Last Updated: September 5, 2015
Last Verified: September 2015