Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
St. Justine's Hospital |
---|---|
Information provided by: | St. Justine's Hospital |
ClinicalTrials.gov Identifier: | NCT00757874 |
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.
Condition | Intervention | Phase |
---|---|---|
Vulvar Lichen Sclerosus |
Drug: Tacolimus cream Drug: Clobetasol cream |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 56 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Tacrolimus cream: Experimental |
Drug: Tacolimus cream
0.5 g per day at bed time for 3 months or less.
|
Clobetasol cream: Active Comparator |
Drug: Clobetasol cream
0.5 gram each day at bed time during 3 months or less.
|
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Deana Funaro, Doctor | 514 345 4931 ext 2579 | rouleau funaro@videotron.ca |
Contact: Claude Belleville, Bacc | 514 345 4931 ext 2579 | claude.belleville@recherche-ste-justine.qc.ca |
Canada, Quebec | |
CHU Sainte-Justine | Recruiting |
Montreal, Quebec, Canada, H3P 3N5 | |
Contact: Claude Belleville 514 345-4931 ext 2579 claude.belleville@recherche-ste-justine.qc.ca | |
Sub-Investigator: Julie Powell, M.D. | |
Sub-Investigator: Valérie Joncas, Fellowship | |
Sub-Investigator: Nathalie Leroux, M.D. | |
Sub-Investigator: Claude Belleville, Coordinator | |
Principal Investigator: Deana Funaro, M.D. |
Principal Investigator: | Deana Funaro, Doctor | CHU Sainte-Justine |
Responsible Party: | CHU Sainte-Justine ( Deana Funaro ) |
Study ID Numbers: | StJustineH |
Study First Received: | September 22, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00757874 History of Changes |
Health Authority: | Canada: Health Canada |
Female urogenital disease skin disease |
Anti-Inflammatory Agents Skin Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Lichen Sclerosis Et Atrophicus Tacrolimus Vulvar Lichen Sclerosus Glucocorticoids |
Hormones Genital Diseases, Female Clobetasol Exanthema Lichen Sclerosus et Atrophicus Vulvar Diseases Skin Diseases, Papulosquamous |
Anti-Inflammatory Agents Skin Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Vulvar Lichen Sclerosus Glucocorticoids Hormones Pharmacologic Actions |
Genital Diseases, Female Clobetasol Therapeutic Uses Lichen Sclerosus et Atrophicus Lichenoid Eruptions Vulvar Diseases Skin Diseases, Papulosquamous |