Clinical Trial

EFESO: Study on Juvenile Onset Eosinophilic Fasciitis

Recruiting
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Record status
This record was last updated March 11, 2026 (before its estimated May 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
Eosinophilic fasciitis is a connective tissue disorder characterized by inflammation of the muscle fasciae, which is very rare in children. In juvenile-onset eosinophilic fasciitis (JEF), there may be severe joint involvement and skin manifestations may be less prevalent than in adults. It represents an important differential diagnosis of both juvenile-onset systemic sclerosis and localized scleroderma, and the correct classification of these patients is necessary to define a targeted diagnostic-therapeutic pathway. The diagnostic criteria proposed for eosinophilic fasciitis in the adult population do not necessarily require confirmation by skin biopsy, currently the "gold standard," which is an invasive procedure for pediatric patients; however, these criteria have never been directly applied to the pediatric population. From a therapeutic point of view, the combination of glucocorticoids and methotrexate is recommended for both adults and pediatric patients, but the data supporting this treatment in children are very limited, and there are no studies comparing the therapeutic approaches currently in use in pediatrics. Finally, there are no studies in the literature documenting the long-term prognosis of these patients in terms of functional limitations, quality of life, or complications related to the disease or treatments.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-09.
Trial Details
NCT Number NCT07348263
Lead Sponsor Meyer Children's Hospital IRCCS
Conditions Eosinophilic Fasciitis
Enrollment 20 participants
Start Date 2025-05-15
Primary Completion 2026-05-15 (estimated)
Study Completion 2027-05-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-11