EFESO: Study on Juvenile Onset Eosinophilic Fasciitis

March 9, 2026 updated by: Gabriele Simonini, Meyer Children's Hospital IRCCS

International Multicentre Cohort Study on Clinical Manifestations and Response to Therapy in Juvenile Onset Eosinophilic Fasciitis

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • Children's Hospital Zagreb
  • Germany
      • Hamburg, Germany
        • Not yet recruiting
        • Hamburger Zentrum für Kinder- und Jugendrheumatologie -
        • Contact:
  • Israel
      • Haifa, Israel
        • Not yet recruiting
        • Ruth Rappaport Children's Hospital of Haifa
  • Italy
    • FI
      • Florence, FI, Italy, 50139
        • Recruiting
        • Meyer Children's Hospital IRCCS
        • Contact:
  • Romania
      • Cluj-Napoca, Romania
        • Recruiting
        • Iuliu Hatieganu University of Medicine and Pharmacy
  • Slovenia
      • Ljubljana, Slovenia
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Sant Joan de Déu,
        • Contact:
  • Sweden
    • Stockholm County
      • Solna, Stockholm County, Sweden, 17164
        • Recruiting
        • Astrid Lindgren Children's Hospital
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Not yet recruiting
        • Cerrahpasa Medical School, Istanbul University
  • United Kingdom
      • Liverpool, United Kingdom
        • Recruiting
        • Alder Hey Children's Hospital
        • Contact:
      • Newcastle upon Tyne, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
    • New York
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Pediatric Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical and laboratory features
Time Frame: 2025-2027
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meyer Children's Hospital IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2027

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFESO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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