Cyclosporine versus methotrexate for children with alopecia areata
The Effectiveness of Cyclosporine Versus Methotrexate in the Treatment of Pediatric Alopecia Areata in Routine Clinical Care: a Patient Preference Trial
PHASE4 · Erasmus Medical Center · NCT07381556
This project tests whether cyclosporine or methotrexate works better as the first systemic treatment for children and teens (ages 2–17) with moderate-to-severe alopecia areata.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center (other) |
| Drugs / interventions | methotrexate, Ritlecitinib |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT07381556 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children and adolescents aged 2–17 with a dermatologist-confirmed diagnosis of moderate-to-severe alopecia areata who are considering systemic therapy and can attend Erasmus MC visits are ideal candidates.
Not a fit: Patients with mild alopecia areata, those already ineligible for both medications, those with contraindications to the assigned drug, or those who cannot adhere to study visits and procedures are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could clarify which systemic drug is more effective and safer as an initial systemic option for children with moderate-to-severe alopecia areata, helping clinicians and families make better treatment choices.
How similar studies have performed: There are limited randomized trials and mainly observational studies supporting systemic CsA or MTX in AA, so head-to-head prospective comparative data in pediatrics are largely lacking.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rotterdam
- Erasmus MC — Rotterdam, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Sophie van Helmond, PhD candidate
- Email: hairresearch@erasmusmc.nl
- Phone: (010) 704 01 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alopecia Areata, Alopecia Totalis/Universalis, Alopecia Universalis, Alopecia Totalis, Pediatric, Alopecia areata, systemic treatment alopecia areata