Cyclosporine versus methotrexate for children with alopecia areata

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, patient-preference clinical trial comparing cyclosporine (CsA) and methotrexate (MTX) in children and adolescents with moderate-to-severe alopecia areata over a treatment period up to 36 weeks, with long-term follow-up through the Pediatric Systemic Alopecia Areata Registry (STA2R-Pediatric). Participants (age 2–17) choose their preferred treatment arm unless contraindicated, and those unable to take CsA are placed in the MTX arm. Outcomes include clinical hair regrowth, safety, and durability of response in routine clinical care settings. The trial aims to fill current gaps in prospective comparative data on off-label systemic therapies used before pediatric JAK inhibitor eligibility.

Why it matters

Who can join: the full rules

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.

Where it's running

• Erasmus MC
  Rotterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Sophie van Helmond, PhD candidate
• Email: hairresearch@erasmusmc.nl
• Phone: (010) 704 01 10

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.