Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus

NCT ID: NCT00757874

Last Updated: 2015-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2010-01-31

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.

Conditions

Vulvar Lichen Sclerosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tacrolimus cream

Group Type: EXPERIMENTAL

Tacrolimus cream

Intervention Type: DRUG

0.5 g per day at bed time for 3 months or less.

Clobetasol cream

Group Type: ACTIVE_COMPARATOR

Clobetasol cream

Intervention Type: DRUG

0.5 gram each day at bed time during 3 months or less.

Interventions

Tacrolimus cream

0.5 g per day at bed time for 3 months or less.

Intervention Type: DRUG

Clobetasol cream

0.5 gram each day at bed time during 3 months or less.

Intervention Type: DRUG

Other Intervention Names

Prtopic; Dermovate

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

Deana Funaro

OTHER

Sponsor Role: lead

Responsible Party

Deana Funaro

Dermatologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Deana Funaro, Doctor

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

CHU Sainte-Justine

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

StJustineH

Identifier Type: -

Identifier Source: org_study_id