A Multi-center Study to Evaluate the Safety of Etanercept in the Treatment of Lichen Planus

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00691106
• Other study ID #: 00000002
• Secondary ID: 31706
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 2, 2008
• Last updated: March 24, 2010
• Start date: March 2007
• Est. completion date: September 2009

Study information

• Verified date: June 2008
• Source: Wake Forest School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: September 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lichen Planus

Intervention

Drug:
• etanercept
Etanercept 50mg will be administered twice weekly by subcutaneous injection for 12 weeks. Those subjects continuing on etanercept beyond 12 weeks will receive a dose of 25mg twice weekly.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences Dermatology	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients achieving a response in mucosal disease (or cutaneous disease if no mucosal disease) at 12 weeks.		12 weeks	No
Secondary	The percentage of patients achieving a response in cutaneous or mucosal disease at 24 weeks.		24 weeks	No