Cyclosporine Or Methotrexate for Pediatric Alopecia Areata: Routine Clinical Care Effectiveness Study

Recruiting now · Phase 4

Conditions studied: Alopecia Areata(AA), Alopecia Areata (AA), Alopecia Totalis/Universalis, Alopecia Universalis (AU), Alopecia Totalis (AT), Alopecia Areata (& Ophiasis)

In brief

Rationale: Since the introduction of Janus kinase (JAK) inhibitors, there has been a significant advancement in the treatment of pediatric alopecia areata. Eligibility for this treatment, in the Netherlands, requires prior failure of systemic therapies such as cyclosporin or methotrexate. However, the choice between methotrexate and cyclosporin as first-line systemic treatment is not supported by robust comparative studies. Therefore, the investigators conduct a patient preference trial with a long-term follow-up provided in the Pediatric Systemic Alopecia Areata Registry (STA2R-Pediatric). This study will evaluate the effectiveness of Cyclosporin (CsA) and Methotrexate (MTX) in children and adolescents with moderate-to-severe AA. Objective(s): To investigate the effectiveness of CsA and MTX in the treatment of children and adolescents with alopecia areata in routine clinical care. Study type: This is a prospective, patient preference clinical trial with a duration up to 36 weeks in accordance with the routine clinical care guidelines. Study population: This study will include children and adolescents (2-17 years old) diagnosed with AA who start first-line systemic treatment. Methods: Patients and their parents will choose between CsA and MTX treatment as in routine clinical care, receiving follow-up in accordance with standard clinical practices. The participants will not be randomized. The primary endpoint is the measurement of the Severity of Alopecia Tool (SALT) at 9-months with a secondary endpoint at 24 weeks. SALT scores will be measured by a blinded assessor. The (Children) - Dermatology Life Quality Index ((C)-DLQI) questionnaire will be conducted at each visit (0, 3, 6, 9 months), allowing evaluation of the impact on patients' quality of life.

Key facts

Study ID: NCT07381556
Run by: Erasmus Medical Center
People needed: 50
Starts: 2025-11-01
Expected to finish: 2027-11-01
Last updated by the study team: 2026-02-02

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

Erasmus MC — Rotterdam, Netherlands (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.