Status:
TERMINATED
A Safety and Efficacy Study of Alefacept in the Treatment of Moderate to Severe Erosive Mucosal Lichen Planus
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Brigham and Women's Hospital
Stanford University
Conditions:
Lichen Planus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out how safe and effective an investigational drug called alefacept (amevive) is for the treatment of moderate to severe erosive mucosal lichen planus. Lichen pla...
Detailed Description
Lichen planus is an inflammatory disorder that affects skin, mucous membranes (the skin in the mouth and vagina), nails, and hair. It is thought that T-cells (cells that help fight infection) become a...
Eligibility Criteria
Inclusion
- Key
- Written informed consent, authorize release and use of protected health information
- At least 18 years of age
- Diagnosis of moderate to severe mucosal lichen planus
- No systemic (oral or injectable) treatment of lichen planus for 4 weeks prior to starting study drug.
- Willing to forgo changes in topical treatment (creams) for 4 weeks before receiving the study drug and during the course of the study.
- Off of topical tacrolimus or pimecrolimus for 4 weeks prior to starting the study drug
- CD4+ T lymphocyte counts must be above the lower limit of normal laboratory value
- Key
Exclusion
- Clinically significant abnormal laboratory values
- Skin lesions currently undiagnosed, but suspicious for malignancy
- Other skin disease that might interfere with lichen planus status assessments.
- History of malignancy other than basal cell carcinomas or fewer than 3 squamous cell carcinomas
- Exposure to systemic therapy for lichen planus within 4 weeks prior to enrollment.
- Previous exposure to alefacept
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00135733
Start Date
April 1 2004
End Date
December 1 2004
Last Update
February 12 2009
Active Locations (1)
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1
Clinical Unit for Research Trials in Skin
Boston, Massachusetts, United States, 02115