Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus
Information source: St. Justine's Hospital
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vulvar Lichen Sclerosus
Intervention: Tacolimus cream (Drug); Clobetasol cream (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: St. Justine's Hospital Official(s) and/or principal investigator(s):
Deana Funaro, Doctor, Principal Investigator, Affiliation: CHU Sainte-Justine
Overall contact:
Deana Funaro, Doctor, Phone: 514 345 4931, Ext: 2579, Email: rouleau funaro@videotron.ca
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.
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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)
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Deana Funaro, Doctor, Phone: 514 345 4931, Ext: 2579, Email: rouleau funaro@videotron.ca
CHU Sainte-Justine, Montreal, Quebec H3P 3N5, Canada; Recruiting
Claude Belleville, Phone: 514 345-4931, Ext: 2579, Email: claude.belleville@recherche-ste-justine.qc.ca
Julie Powell, M.D., Sub-Investigator
Valérie Joncas, Fellowship, Sub-Investigator
Nathalie Leroux, M.D., Sub-Investigator
Claude Belleville, Coordinator, Sub-Investigator
Deana Funaro, M.D., Principal Investigator
Additional Information
Starting date: April 2006
Ending date: April 2009
Last updated: January 13, 2009
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