Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 2009

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Tacrolimus cream
  • Active Comparator: Clobetasol cream

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 2 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Deana Funaro
  • Collaborator
    • Astellas Pharma Inc
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Deana Funaro, Dermatologist – St. Justine’s Hospital
  • Overall Official(s)
    • Deana Funaro, Doctor, Principal Investigator, St. Justine’s Hospital

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