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

NCT07381556 | Recruiting Phase 4

• 1 other identifier: MEC-2025-0562
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata(AA); Alopecia Areata (AA); Alopecia Totalis/Universalis; Alopecia Universalis (AU); Alopecia Totalis (AT); Alopecia Areata (& Ophiasis)

Keywords

Pediatric; Alopecia areata; systemic treatment alopecia areata

Outcome Measures

Primary Outcomes (1)

• SALT 36 weeks

  To compare SALT\* (delta-SALT and SALT\<20) between baseline and 36 weeks of treatment between the CsA and MTX group. \* The Severity of Alopecia Tool (SALT) score is a standardized, numerical measure (0-100) used by dermatologists to quantify scalp hair loss in patients with alopecia areata. A score of 0 indicates no hair loss, while 100 indicates total scalp hair loss.

  36 weeks

Secondary Outcomes (4)

• SALT 24 weeks

  24 weeks

• Quality of life (DLQI)

  24, 36 weeks

• Adverse events

  0, 12, 24, 36 weeks

• Discontinuation of therapy

  0, 12, 24, 36 weeks

Study Arms (2)

Methotrexate (MTX)

ACTIVE COMPARATOR

Methotrexate is administered orally or intramusculairly and dosed 10-15mg/m2, 1 times a week, with folate suppletion 24 hours after MTX intkae

Drug: Methotrexate

Cyclosporine (Cyclo)

ACTIVE COMPARATOR

Cyclosporine is given orally, dosed 3-5mg/kg/day and divided in to two doses/ day

Drug: Cyclosporin (CSA)

Interventions

Methotrexate DRUG

MTX is given at a dose of 10-15mg/m2 per week, orally or subcutaneously. Additionally, folate supplementation is administered concurrently as part of standard care, with folate 5-10 mg/week administered 24 hours after MTX intake.

Methotrexate (MTX)

Cyclosporin (CSA) DRUG

CSA is given orally (tablet or liquid form) and dosed 3-5mg/kg/day, divided into two doses a day

Cyclosporine (Cyclo)

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis

Interventions

Methotrexate; Cyclosporine

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Sophie van Helmond, PhD candidate

CONTACT

(010) 704 01 10; hairresearch@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of Department of Dermatology, MD, PhD.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: February 2, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

NL (1)