EFESO: Study on Juvenile Onset Eosinophilic Fasciitis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Meyer Children's Hospital IRCCS
Study ID
NCT07348263
Status
Recruiting

Conditions

  • Eosinophilic Fasciitis

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
May 15, 2025
Status verified
Mar 2026
Primary completion
May 15, 2026
Completion
May 15, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Juvenile eosinophilic fasciitis
    Age \< 18 years at diagnosis \- The study will include two different populations: 1. Patients who have received a diagnosis of JEF based on deep fascial biopsy characteristics. 2. Patients who have received a diagnosis of JEF based on typical MRI findings, but without performing a deep fascial biopsy.

Primary Outcome Measure

Clinical and laboratory features [ Time Frame: 2025-2027 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
SUNY Upstate Pediatric RheumatologySyracuseNew York13210-

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