A Multi-center Study to Evaluate the Safety of Etanercept in the Treatment of Lichen Planus
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- The percentage of patients achieving a response in mucosal disease (or cutaneous disease if no mucosal disease) at 12 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- The percentage of patients achieving a response in cutaneous or mucosal disease at 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||September 2009|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
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.
|United States, North Carolina|
|Wake Forest University Health Sciences Dermatology|
|Winston Salem, North Carolina, United States, 27157|
|Principal Investigator:||Joseph Jorizzo, MD||Wake Forest University|