Actively Recruiting
Cyclosporine Or Methotrexate for Pediatric Alopecia Areata: Routine Clinical Care Effectiveness Study
Led by Erasmus Medical Center · Updated on 2026-02-02
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cyclosporine Or Methotrexate for Pediatric Alopecia Areata: Routine Clinical Care Effectiveness Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2-17 years
- Clinical diagnosis of alopecia areata by a certified dermatologist
- Willingness of participant (if aged 12-17 years) and parents to provide informed consent for participation
You will not qualify if you...
- Inability to follow the study protocol including medication intake, clinic visits, and questionnaire completion
- Contraindications to Cyclosporin including impaired kidney function, poorly controlled hypertension, active infections, malignancy, or nephrotic syndrome with complications
- Contraindications to Methotrexate including pregnancy or lactation, severe kidney or liver dysfunction, alcohol abuse, bone marrow problems, immunodeficiency, anemia, leukopenia, thrombocytopenia, poor nutrition, allergy to methotrexate, or lung toxicity due to methotrexate
- Patients who cannot take Cyclosporin are assigned to Methotrexate, and vice versa
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
Research Team
S
Sophie van Helmond, PhD candidate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here