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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07381556
Eligibility Criteria:
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Age 2-17 years
* Clinical diagnosis of AA by a certified dermatologist
* Willingness of participant (in case 12-17 years) and parents to provide informed consent for participation in the study.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Inability to adhere to the study protocol, including medication intake, clinic visits, and questionnaire completion.
* Patients who are ineligible for the CsA arm (due to contraindications), are automatically included in the MTX arm.
* Contra-indications CsA:
Impaired kidney function. Poorly controlled hypertension Active infections. Presence of a malignancy. Nephrotic syndrome combined with poorly controlled hypertension, infection or malignancy.
Kidney disorders, except in cases of nephrotic syndrome with mild to moderate renal impairment.
* Patients who are ineligible for the MTX arm (due to contraindications), are automatically included in the CsA arm.
* Contraindications MTX:
Conception (both male and female) and lactation Severe kidney or liver dysfunction (fibrosis, cirrhosis) or alcohol abuse Bone marrow hypoplasia, immunodeficiency Anemia, leukopenia, or thrombocytopenia Poor nutritional status (low albumin) Hypersensitivity or allergy to MTX Lung toxicity due to MTX or significant reduction in lung function.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT07381556
Study Brief:
Protocol Section:
NCT07381556