Status:
COMPLETED
Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus
Lead Sponsor:
Deana Funaro
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Vulvar Lichen Sclerosus
Eligibility:
FEMALE
2+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Female, 2 years or older
- Medical diagnosis of vulvar lichen sclerosus
- Received no treatment during the last 4 weeks
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00757874
Start Date
April 1 2006
End Date
January 1 2010
Last Update
September 9 2015
Active Locations (1)
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1
CHU Sainte-Justine
Montreal, Quebec, Canada, H3P 3N5