Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus

Study Overview
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Brief Summary
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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.

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

Conditions
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Vulvar Lichen Sclerosus

Intervention / Treatment
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* Drug: Tacrolimus cream
* Drug: Clobetasol cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus cream<br> | Drug: Tacrolimus cream<br>* 0.5 g per day at bed time for 3 months or less.<br>* Other names: Prtopic;|
| Active Comparator: Clobetasol cream<br> | Drug: Clobetasol cream<br>* 0.5 gram each day at bed time during 3 months or less.<br>* Other names: Dermovate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Comparison before the treatment and monthly for 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared presence and severity of side effects of both groups. |  | During the 3 months of treatment | 
| CBC, Glycemia, vitamine B 12 dosage, TSH (to find associated auto-immune diseases) |  | At 1 to 3 months after starting the study, collected once. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female urogenital disease, skin disease