Alopecia Areata Clinical Trials

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The Effectiveness of Cyclosporine Versus Methotrexate in the Treatment of Pediatric Alopecia Areata in Routine Clinical Care: a Patient Preference Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Contact Information
Primary
Sophie van Helmond, PhD candidate
hairresearch@erasmusmc.nl
(010) 704 01 10
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 50
Treatments
Active_comparator: Methotrexate (MTX)
Methotrexate is administered orally or intramusculairly and dosed 10-15mg/m2, 1 times a week, with folate suppletion 24 hours after MTX intkae
Active_comparator: Cyclosporine (Cyclo)
Cyclosporine is given orally, dosed 3-5mg/kg/day and divided in to two doses/ day
Sponsors
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov