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

RecruitingPhase 4Ages 2 Years - 17 YearsAllErasmus Medical Center
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In plain words

What the trial is, and whether it could suit you

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. St

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Methotrexate
  • Cyclosporin (CSA)
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Where

1 site
Erasmus MC
Rotterdam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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