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:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT07029204
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 65 at screening visit.
* Diagnosis of alopecia areata by a board-certified dermatologist at screening visit.
* Current alopecia areata episode involving the scalp of more than 3 months' duration prior to baseline visit.
* SALT Score between 10 and 50 at baseline visit.
* Stable disease based on subject history over the past 1 month.
* Agree not to use any alopecia areata treatments during the study, including, but not limited to: systemic therapies (eg, methotrexate, cyclosporine, corticosteroids, JAK inhibitors) and biologics (eg, monoclonal antibodies), intralesional corticosteroid injections, topical therapies, and phototherapy
Exclusion Criteria:
* Currently experiencing other forms of alopecia. Including but not limited to: androgenetic alopecia, telogen effluvium, or any other concomitant conditions (eg, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that could interfere with evaluation of alopecia areata
* Previous treatment with cyclosporine
* Other autoimmune diseases
* Pregnancy or lactation
* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking study drug or interfere with the interpretation of data. These may include, but are not limited to, patients with untreated hypertension, patients with known renal disease with decreased GFR, and known infection.
* Adults unable to consent
* Prisoners
* Currently using drugs that are well-substantiated to interact with cyclosporine, including the following: ciprofloxacin, gentamicin, tobramycin, trimethoprim with sulfamethaxazole, vancomycin, melphalan, amphotericin B, ketoconazole, azapropazon, colchicine, diclofenac, naproxen, sulindac, cimetidine, ranitidine, tacrolimus, fibric acid derivatives (e.g. bezafibrate, fenofibrate), and methotrexate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07029204
Study Brief:
Protocol Section:
NCT07029204