Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus
Recruitment status was Active, not recruiting
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Purpose
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: Tacrolimus cream Drug: Clobetasol cream |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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. |
- 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 [ Time Frame: Comparison before the treatment and monthly for 3 months. ] [ Designated as safety issue: No ]
- Compared presence and severity of side effects of both groups. [ Time Frame: During the 3 months of treatment ] [ Designated as safety issue: Yes ]
- CBC, Glycemia, vitamine B 12 dosage, TSH (to find associated auto-immune diseases) [ Time Frame: At 1 to 3 months after starting the study, collected once. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tacrolimus cream |
Drug: Tacrolimus cream
0.5 g per day at bed time for 3 months or less.
Other Name: Prtopic
|
| Active Comparator: Clobetasol cream |
Drug: Clobetasol cream
0.5 gram each day at bed time during 3 months or less.
Other Name: Dermovate
|
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Deana Funaro, CHU Sainte-Justine |
| ClinicalTrials.gov Identifier: | NCT00757874 History of Changes |
| Other Study ID Numbers: | StJustineH |
| Study First Received: | September 22, 2008 |
| Last Updated: | September 17, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by St. Justine's Hospital:
|
Female urogenital disease skin disease |
Additional relevant MeSH terms:
|
Vulvar Lichen Sclerosus Lichen Sclerosus et Atrophicus Vulvar Diseases Genital Diseases, Female Lichenoid Eruptions Skin Diseases, Papulosquamous Skin Diseases Clobetasol Tacrolimus |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013