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NCT07381556: COMPARE
Cyclosporine Or Methotrexate for Pediatric Alopecia Areata: Routine Clinical Care Effectiveness Study
Phase 4 trial testing Methotrexate in Alopecia Areata(AA) in 50 participants. Currently enrolling.
1 November 2027
Quick facts
| Lead sponsor | Erasmus Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 November 2025 |
| Primary completion | 1 November 2027 |
| Estimated completion | 1 November 2027 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Methotrexate — full drug profile →
- Cyclosporin (CSA) — full drug profile →
Conditions studied
- Alopecia Areata(AA) — all drugs for Alopecia Areata(AA) →
- Alopecia Areata (AA) — all drugs for Alopecia Areata (AA) →
- Alopecia Totalis/Universalis — all drugs for Alopecia Totalis/Universalis →
- Alopecia Universalis (AU) — all drugs for Alopecia Universalis (AU) →
Sponsor
Erasmus Medical Center
Who can join
Adults 2 to 17, any sex, with Alopecia Areata(AA) or Alopecia Areata (AA). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07381556 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Erasmus Medical Center
- Last refreshed: 2 February 2026
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