A Multi-Center Study to Evaluate the Safety of Etanercept in the Treatment of Lichen Planus
Information source: Wake Forest University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lichen Planus
Intervention: etanercept (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Wake Forest University
Official(s) and/or principal investigator(s):
Joseph Jorizzo, MD, Principal Investigator, Affiliation: Wake Forest University
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
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
Primary outcome: The percentage of patients achieving a response in mucosal disease (or cutaneous disease if no mucosal disease) at 12 weeks.
Secondary outcome: The percentage of patients achieving a response in cutaneous or mucosal disease at 24 weeks.
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
Minimum age: 18 Years.
Maximum age: N/A.
- At least 18 years of age.
- Must carry a diagnosis of lichen planus as determined by either a skin or mucosal
- 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.
- 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.
Locations and Contacts
Wake Forest University Health Sciences Dermatology, Winston Salem, North Carolina 27157, United States
Starting date: March 2007
Ending date: September 2008
Last updated: June 10, 2008