NCT07381556 Cyclosporine Or Methotrexate for Pediatric Alopecia Areata: Routine Clinical Care Effectiveness Study
| NCT ID | NCT07381556 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Erasmus Medical Center |
| Condition | Alopecia Areata(AA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2025-11-01 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07381556 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Alopecia Areata(AA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07381556 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07381556 currently recruiting?
Yes, NCT07381556 is actively recruiting participants. Contact the research team at hairresearch@erasmusmc.nl for enrollment information.
Where is the NCT07381556 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT07381556 clinical trial?
NCT07381556 is sponsored by Erasmus Medical Center. The trial plans to enroll 50 participants.