Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757874
• Other study ID #: StJustineH
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2008
• Last updated: September 5, 2015
• Start date: April 2006
• Est. completion date: January 2010

Study information

• Verified date: September 2015
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 2 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lichen Sclerosus et Atrophicus
• Vulvar Lichen Sclerosus

Intervention

Drug:
• Tacrolimus cream
0.5 g per day at bed time for 3 months or less.
• Clobetasol cream
0.5 gram each day at bed time during 3 months or less.

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Deana Funaro	Astellas Pharma Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Compared presence and severity of side effects of both groups.		During the 3 months of treatment	Yes
Secondary	CBC, Glycemia, vitamine B 12 dosage, TSH (to find associated auto-immune diseases)		At 1 to 3 months after starting the study, collected once.	No