Eosinophilic FasciitisNCT07348263
EFESO: Study on Juvenile Onset Eosinophilic Fasciitis
An observational study of Eosinophilic Fasciitis, run by Meyer Children's Hospital IRCCS at 15 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Eosinophilic Fasciitis
- How many people
- 20 participants
- Where
- 15 sitesin 11 countries
- Study dates
- 15 May 2025to 15 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- Age ≥18 years at diagnosis;
- Unwilling to participate into the study;
- A follow-up period < 6 months.
Trial locations and contacts
15 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 11 countries
Italy3 sites, 3 recruiting
- Recruiting
Meyer Children's Hospital IRCCS
Florence, FI, 50139
Edoardo Marrani, +390555662913, edoardo.marrani@meyer.it
- Recruiting
IRCCS Giannina Gaslini,
Genova
Riccardo Papa, riccardo.papa@gaslini.it
- Not yet recruiting
Università di Udine
Udine
Giorgia Martini, giorgia.martini@uniud.it
United States2 sites, 2 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
- Recruiting
SUNY Upstate Pediatric Rheumatology
Syracuse, New York, 13210
United Kingdom2 sites, 2 recruiting
- Recruiting
Alder Hey Children's Hospital
Liverpool
Clare Pain, Clare.Pain@alderhey.nhs.uk, Clare.Pain@alderhey.nhs.uk
- Not yet recruiting
Great North Children's Hospital, Newcastle Upon Tyne
Newcastle upon Tyne
Miguel Bernardo, miguelbernardo.mb92@gmail.com
Croatia1 site, 1 recruiting
- Recruiting
Children's Hospital Zagreb
Zagreb, 10000
Germany1 site, 1 recruiting
- Not yet recruiting
Hamburger Zentrum für Kinder- und Jugendrheumatologie -
Hamburg
Ivan Foldvari, foeldvari@t-online.de
Israel1 site, 1 recruiting
- Not yet recruiting
Ruth Rappaport Children's Hospital of Haifa
Haifa
Romania1 site, 1 recruiting
- Recruiting
Iuliu Hatieganu University of Medicine and Pharmacy
Cluj-Napoca
Slovenia1 site, 1 recruiting
- Not yet recruiting
University Children's Hospital
Ljubljana
Natasa Toplak, natasa.toplak@kclj.si
Spain1 site, 1 recruiting
- Not yet recruiting
Hospital Sant Joan de Déu,
Barcelona
Joan Calzada Hernández, joan.calzada@sjd.es
Sweden1 site, 1 recruiting
- Recruiting
Astrid Lindgren Children's Hospital
Solna, Stockholm County, 17164
Turkey (Türkiye)1 site, 1 recruiting
- Not yet recruiting
Cerrahpasa Medical School, Istanbul University
Istanbul
About this study
Official title: 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.
- Conditions
- Eosinophilic Fasciitis
- Keywords
- Eosinophilic Fasciitis, Juvenile eosinophilic fasciitis, juvenile scleroderma, sclerosing disorders
- Medical subject headings
- Eosinophilic Fasciitis, Juvenile-onset scleroderma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2025-2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start15 May 2025
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic FasciitisStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Simonini, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348263
- Sponsor's protocol ID
- EFESO
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicentre Cohort Study on Clinical Manifestations and Response to Therapy in Juvenile Onset Eosinophilic Fasciitis
- ClinicalTrials.gov ID
- NCT07348263
- Acronym / sponsor ID
- EFESO
- Conditions
- Eosinophilic Fasciitis
- Keywords
- Eosinophilic Fasciitis, Juvenile eosinophilic fasciitis, juvenile scleroderma, sclerosing disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Age ≥18 years at diagnosis;
- Unwilling to participate into the study;
- A follow-up period < 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Fasciitis, run by Meyer Children's Hospital IRCCS at 15 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy, United States, United Kingdom, Croatia, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edoardo Marrani (+390555662913, edoardo.marrani@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and laboratory features (time frame: 2025-2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.