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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Wake Forest School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00691106
First received: June 2, 2008
Last updated: March 24, 2010
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Lichen Planus
Drug: etanercept
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • The percentage of patients achieving a response in cutaneous or mucosal disease at 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: March 2007
Estimated Study Completion Date: September 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691106

Locations
United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Joseph Jorizzo, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Joseph Jorizzo, MD, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00691106     History of Changes
Other Study ID Numbers: 00000002, 31706
Study First Received: June 2, 2008
Last Updated: March 24, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lichen Planus
Lichenoid Eruptions
Skin Diseases
Skin Diseases, Papulosquamous
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014