Lichen Planus Clinical Trial
Official title:
A Double-blind, Randomized, Multi-center Study to Evaluate the Safety and Efficacy of Etanercept 50 mg Twice Weekly Versus Etanercept 25 mg Twice Weekly Versus Placebo in the Treatment of Lichen Planus
This is a research study whose purpose is to test the effectiveness of etanercept (Enbrel) in the treatment of moderate to severe lichen planus. No studies have been done on the effectiveness of etanercept in lichen planus, although etanercept has been tested and used on other medical conditions. Etanercept has not been FDA approved for the treatment of lichen planus.
Lichen planus is a chronic, inflammatory skin disease which can be particularly difficult to
treat. The exact cause of lichen planus is not clear, but a number of studies suggest that
immune system cells called T lymphocytes play a role through abnormally increased activity.
Etanercept is a drug which helps to maintain proper T lymphocyte activity and has been FDA
approved for the treatment of psoriasis, another skin condition known to be caused by T
cells with abnormally increased activity. There is no known cure for lichen planus. We hope
to learn if etanercept represents an effective and safe treatment for lichen planus.
This research study is looking for 64 people with lichen planus. The study will be conducted
at 12 sites across the United States. Approximately 5 subjects will be enrolled at this
site.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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