EFESO: Study on Juvenile Onset Eosinophilic Fasciitis

NCT ID: NCT07348263

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-15

Study Completion Date

2027-05-15

Brief Summary

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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 (Pinal-Fernandez et al. 20145; JInnin M 20186) 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.

Detailed Description

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Conditions

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Eosinophilic Fasciitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meyer Children's Hospital IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Gabriele Simonini

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

SUNY Upstate Pediatric Rheumatology

Syracuse, New York, United States

Site Status RECRUITING

Children's Hospital Zagreb

Zagreb, , Croatia

Site Status RECRUITING

Meyer Children's Hospital IRCCS

Florence, FI, Italy

Site Status RECRUITING

Iuliu Hatieganu University of Medicine and Pharmacy

Cluj-Napoca, , Romania

Site Status RECRUITING

Astrid Lindgren Children's Hospital

Solna, Stockholm County, Sweden

Site Status RECRUITING

Countries

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United States Croatia Italy Romania Sweden

Central Contacts

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Edoardo Marrani

Role: CONTACT

+390555662913

Facility Contacts

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Edoardo Marrani

Role: primary

+390555662913

Other Identifiers

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EFESO

Identifier Type: -

Identifier Source: org_study_id

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