Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT00135733
Eligibility Criteria:
Key Inclusion Criteria:
* Written informed consent, authorize release and use of protected health information
* At least 18 years of age
* Diagnosis of moderate to severe mucosal lichen planus
* No systemic (oral or injectable) treatment of lichen planus for 4 weeks prior to starting study drug.
* Willing to forgo changes in topical treatment (creams) for 4 weeks before receiving the study drug and during the course of the study.
* Off of topical tacrolimus or pimecrolimus for 4 weeks prior to starting the study drug
* CD4+ T lymphocyte counts must be above the lower limit of normal laboratory value
Key Exclusion Criteria:
* Clinically significant abnormal laboratory values
* Skin lesions currently undiagnosed, but suspicious for malignancy
* Other skin disease that might interfere with lichen planus status assessments.
* History of malignancy other than basal cell carcinomas or fewer than 3 squamous cell carcinomas
* Exposure to systemic therapy for lichen planus within 4 weeks prior to enrollment.
* Previous exposure to alefacept
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00135733
Study Brief:
Protocol Section:
NCT00135733