A Multi-center Study to Evaluate the Safety of Etanercept in the Treatment of Lichen Planus
This trial is active, not recruiting.
|Sponsor||Wake Forest School of Medicine|
|Start date||March 2007|
|End date||March 2008|
|Trial size||5 participants|
|Trial identifier||NCT00691106, 00000002, 31706|
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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
The percentage of patients achieving a response in mucosal disease (or cutaneous disease if no mucosal disease) at 12 weeks.
time frame: 12 weeks
The percentage of patients achieving a response in cutaneous or mucosal disease at 24 weeks.
time frame: 24 weeks
Male or female participants at least 18 years old.
Inclusion Criteria: - At least 18 years of age. - Must carry a diagnosis of lichen planus as determined by either a skin or mucosal biopsy - Patients must have a score of 3 or greater (moderate-severe) on the PGA for cutaneous or mucosal disease - Patient must be considered appropriate for systemic therapy based upon fulfilling one of the following criteria: - inability to maintain weight due to pain with eating, chewing, or swallowing; - dyspareunia or dysuria due to genital lesions; - itch/pain of sufficient severity that activities of daily living are significantly affected—this includes sleeping, cleansing oneself, performing one's occupation. Exclusion Criteria: - Known HIV-positive status, any other immuno-suppressive disease, or inability to practice safe sex during the length of the study - Subject has been diagnosed with a malignancy within the past 5 years except for successfully treated non-melanoma skin cancer or in-situ cervical carcinoma. - Subject has signs or symptoms of a lymphoproliferative disease. - Other skin or mucosal disease that might interfere with lichen planus assessments, including signs of squamous cell carcinoma. - Lichen planus variants including hypertrophic, atrophic, follicular (including lichen planopilaris), and bullous cutaneous forms.
|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|
|Principal investigator||Joseph Jorizzo, MD|
|Description||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.|
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