Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus

Phase 2

Completed

• Conditions: Vulvar Lichen Sclerosus
• Interventions: Drug: Tacrolimus cream; Drug: Clobetasol cream

• Registration Number: NCT00757874
• Lead Sponsor: Deana Funaro

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 Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Primary Completion: 2009-11
• Study Completion: 2010-01
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-05
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus cream	Tacrolimus cream	-
Clobetasol cream	Clobetasol cream	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada