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Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus

Information source: St. Justine's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vulvar Lichen Sclerosus

Intervention: Tacrolimus cream (Drug); Clobetasol cream (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: St. Justine's Hospital

Official(s) and/or principal investigator(s):
Deana Funaro, Doctor, Principal Investigator, Affiliation: St. Justine's Hospital


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.

Clinical Details

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.

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

Primary outcome: 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

Secondary outcome:

Compared presence and severity of side effects of both groups.

CBC, Glycemia, vitamine B 12 dosage, TSH (to find associated auto-immune diseases)


Minimum age: 2 Years. Maximum age: N/A. Gender(s): Female.


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


- 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

Locations and Contacts

CHU Sainte-Justine, Montreal, Quebec H3P 3N5, Canada
Additional Information

Starting date: April 2006
Last updated: September 17, 2009

Page last updated: August 23, 2015

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