Clinical trial NCT00757874: Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vulvar Lichen Sclerosus
Keywords: Female urogenital disease
skin disease
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2008-09-23
Enrollment: 56
Sex: FEMALE
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Comparison before the treatment and monthly for 3 months.
Secondary outcomes:
measure: Compared presence and severity of side effects of both groups.
timeFrame: During the 3 months of treatment
measure: CBC, Glycemia, vitamine B 12 dosage, TSH (to find associated auto-immune diseases)
timeFrame: At 1 to 3 months after starting the study, collected once.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Deana Funaro, Doctor
role: PRINCIPAL_INVESTIGATOR
References: