Overview

This trial is active, not recruiting.

Condition lichen planus
Treatment etanercept
Phase phase 2
Sponsor Wake Forest School of Medicine
Start date March 2007
End date March 2008
Trial size 5 participants
Trial identifier NCT00691106, 00000002, 31706

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment

Primary Outcomes

Measure
The percentage of patients achieving a response in mucosal disease (or cutaneous disease if no mucosal disease) at 12 weeks.
time frame: 12 weeks

Secondary Outcomes

Measure
The percentage of patients achieving a response in cutaneous or mucosal disease at 24 weeks.
time frame: 24 weeks

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.