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Recruiting NCT07348263

NCT07348263 EFESO: Study on Juvenile Onset Eosinophilic Fasciitis

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Clinical Trial Summary
NCT ID NCT07348263
Status Recruiting
Phase
Sponsor Meyer Children's Hospital IRCCS
Condition Eosinophilic Fasciitis
Study Type OBSERVATIONAL
Enrollment 20 participants
Start Date 2025-05-15
Primary Completion 2026-05-15

Eligibility & Interventions

Sex All sexes
Min Age N/A
Max Age 18 Years
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 20 participants in total. It began in 2025-05-15 with a primary completion date of 2026-05-15.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

Inclusion criterai: All patients diagnosed from 2000 to 31/12/2026 * minimum follow-up 6 months * Age \<18 years at diagnosis; * All patients whose informed consent is collected in accordance with current local legislation will also be considered enrollable. Exclusion Criteria: * Age ≥18 years at diagnosis; * Unwilling to participate into the study; * A follow-up period \< 6 months.

Contact & Investigator

Central Contact

Edoardo Marrani

✉ edoardo.marrani@meyer.it

📞 +390555662913

Frequently Asked Questions

Who can join the NCT07348263 clinical trial?

This trial is open to participants of all sexes, up to 18 Years, studying Eosinophilic Fasciitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07348263 currently recruiting?

Yes, NCT07348263 is actively recruiting participants. Contact the research team at edoardo.marrani@meyer.it for enrollment information.

Where is the NCT07348263 trial being conducted?

This trial is being conducted at Birmingham, United States, Syracuse, United States, Zagreb, Croatia, Hamburg, Germany and 11 additional locations.

Who is sponsoring the NCT07348263 clinical trial?

NCT07348263 is sponsored by Meyer Children's Hospital IRCCS. The trial plans to enroll 20 participants.

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