Vulvar Lichen Sclerosus Clinical Trial
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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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