Actively Recruiting
Effectiveness of Cyclosporine Versus Methotrexate for Pediatric Alopecia Areata in Routine Clinical Care: A Patient Preference Trial
Led by Erasmus Medical Center · Updated on 2026-02-02
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of Cyclosporin (CsA) and Methotrexate (MTX) in treating children and adolescents aged 2 to 17 years with moderate-to-severe alopecia areata (AA). This patient preference clinical trial aims to compare these two systemic treatments in routine clinical care, as there is currently limited evidence guiding the choice between them. The study also collects long-term data through the Pediatric Systemic Alopecia Areata Registry to improve understanding of treatment outcomes and safety. Participants and their parents choose between CsA and MTX for their first systemic treatment, following usual care guidelines. Methotrexate is given orally or by injection once a week at 10-15 mg/m2 with folate supplements, while Cyclosporine is taken orally twice daily at 3-5 mg/kg per day. The trial lasts up to 36 weeks, with assessments at several visits according to standard clinical practices. Throughout the study, researchers will measure the Severity of Alopecia Tool (SALT) scores at 24 and 36 weeks to assess hair loss severity, with a blinded assessor conducting these evaluations. Participants complete quality of life questionnaires at each visit (0, 3, 6, and 9 months). Safety is monitored through reports of adverse events and therapy discontinuation. This study provides insight into the impact of treatment on hair loss and patient well-being over time.
CONDITIONS
Brief Title
Cyclosporine Or Methotrexate for Pediatric Alopecia Areata: Routine Clinical Care Effectiveness Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 to 17 years
- Clinical diagnosis of alopecia areata by a certified dermatologist
- Willingness of participant (if 12-17 years) and parents to provide informed consent for participation in the study
You will not qualify if you...
- Inability to adhere to the study protocol including medication intake, clinic visits, and questionnaire completion
- Contraindications to Cyclosporine such as impaired kidney function, poorly controlled hypertension, active infections, malignancy, or complicated nephrotic syndrome
- Contraindications to Methotrexate such as pregnancy or lactation, severe kidney or liver dysfunction, bone marrow problems, anemia, poor nutrition, allergy to Methotrexate, or lung toxicity related to Methotrexate
- Patients ineligible for Cyclosporine are assigned to Methotrexate and vice versa
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 weeks
Participants receive either Cyclosporine or Methotrexate as first-line systemic treatment for moderate-to-severe alopecia areata according to routine clinical care protocols.
Visits at 0, 3, 6, 9 months for assessments and questionnaires
Duration - Beyond 36 weeks
After treatment, participants are followed in the Pediatric Systemic Alopecia Areata Registry for long-term outcomes and safety monitoring.
Follow-up visits according to the registry protocol
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
Research Team
S
Sophie van Helmond, PhD candidate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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