EFESO: Study on Juvenile Onset Eosinophilic Fasciitis

NCT07348263 | Recruiting DMC

• 1 other identifier: EFESO
• Study Type: observational
• Target: 20
• Locations: 11 countries
• Sites: 15

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.

Conditions

Eosinophilic Fasciitis

Keywords

Eosinophilic Fasciitis; Juvenile eosinophilic fasciitis; juvenile scleroderma; sclerosing disorders

Outcome Measures

Primary Outcomes (1)

• Clinical and laboratory features

  Describe the clinical and laboratory features at presentation and during follow-up, including the extent of skin involvement and extracutaneous manifestations, of patients diagnosed with JEF.

  2025-2027

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include patients diagnosed with eosinophilic fasciitis before \<18 years of age, separated into two different populations: Patients who received a diagnosis of JEF based on deep fascial biopsy features. Patients who received a diagnosis of JEF based on typical MRI findings but without deep fascial biopsy. Patients with localized or systemic scleroderma who underwent deep fascial biopsy, in a 1:1 ratio with patients with juvenile eosinophilic fasciitis will be enrolled as a comparison group

You may not qualify if:

• Age ≥18 years at diagnosis;
• Unwilling to participate into the study;
• A follow-up period \< 6 months.

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (15)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

SUNY Upstate Pediatric Rheumatology

Syracuse, New York, 13210, United States

RECRUITING

Children's Hospital Zagreb

Zagreb, 10000, Croatia

RECRUITING

Hamburger Zentrum für Kinder- und Jugendrheumatologie -

Hamburg, Germany

NOT YET RECRUITING

Ruth Rappaport Children's Hospital of Haifa

Haifa, Israel

NOT YET RECRUITING

Meyer Children's Hospital IRCCS

Florence, FI, 50139, Italy

RECRUITING

IRCCS Giannina Gaslini,

Genova, Italy

RECRUITING

Università di Udine

Udine, Italy

NOT YET RECRUITING

Iuliu Hatieganu University of Medicine and Pharmacy

Cluj-Napoca, Romania

RECRUITING

University Children's Hospital

Ljubljana, Slovenia

NOT YET RECRUITING

Hospital Sant Joan de Déu,

Barcelona, Spain

NOT YET RECRUITING

Astrid Lindgren Children's Hospital

Solna, Stockholm County, 17164, Sweden

RECRUITING

Cerrahpasa Medical School, Istanbul University

Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

Alder Hey Children's Hospital

Liverpool, United Kingdom

RECRUITING

Great North Children's Hospital, Newcastle Upon Tyne

Newcastle upon Tyne, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Eosinophilic Fasciitis; Juvenile-onset scleroderma

Central Study Contacts

Edoardo Marrani

CONTACT

+390555662913; edoardo.marrani@meyer.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

SE (1); IT (3); US (2); CR (1); RO (1); TU (1); GB (2); DE (1); IL (1); SL (1); ES (1)