Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus
Primary Purpose
Vulvar Lichen Sclerosus
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Tacrolimus cream
Clobetasol cream
Sponsored by
About this trial
This is an interventional treatment trial for Vulvar Lichen Sclerosus focused on measuring Female urogenital disease, skin disease
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
Sites / Locations
- CHU Sainte-Justine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tacrolimus cream
Clobetasol cream
Arm Description
Outcomes
Primary Outcome Measures
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 Measures
Compared presence and severity of side effects of both groups.
CBC, Glycemia, vitamine B 12 dosage, TSH (to find associated auto-immune diseases)
Full Information
NCT ID
NCT00757874
First Posted
September 22, 2008
Last Updated
September 5, 2015
Sponsor
Deana Funaro
Collaborators
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT00757874
Brief Title
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
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Deana Funaro
Collaborators
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Lichen Sclerosus
Keywords
Female urogenital disease, skin disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tacrolimus cream
Arm Type
Experimental
Arm Title
Clobetasol cream
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tacrolimus cream
Other Intervention Name(s)
Prtopic
Intervention Description
0.5 g per day at bed time for 3 months or less.
Intervention Type
Drug
Intervention Name(s)
Clobetasol cream
Other Intervention Name(s)
Dermovate
Intervention Description
0.5 gram each day at bed time during 3 months or less.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Compared presence and severity of side effects of both groups.
Time Frame
During the 3 months of treatment
Title
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deana Funaro, Doctor
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3P 3N5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus
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