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 fasciitisAge \< 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
- Edoardo Marrani+390555662913
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | - |
| SUNY Upstate Pediatric Rheumatology | Syracuse | New York | 13210 | - |