NCT06423573From ClinicalTrials.govRecruiting

A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez

A Long-term Non-interventional Study to Assess the Incidence of Skin Malignancies in Patients With Dystrophic and Junctional Epidermolysis Bullosa Receiving Treatment With Filsuvez

Epidermolysis Bullosa, Dystrophic
Epidermolysis Bullosa, Junctional

At a glance

Phase: Phase not stated
Study type: Observational
Sponsor: Chiesi Farmaceutici S.p.A.
Enrolment target: 170
Started: 18 December 2024
Main results due: 30 November 2031
Study sites: 12
Registry updated: 28 September 2026

Can you take part?

No age limit is stated.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

* Patients with a confirmed diagnosis of dystrophic EB or junctional EB

Exclusion Criteria:

* None

What this study is about

In the sponsor’s own words, from the registry.

In patients with epidermolysis bullosa (EB), collagen does not form properly, so their skin is very fragile and blisters easily. Such patients are also at greatly increased risk of developing skin cancers. Filsuvez is a topical gel used to promote healing of skin lesions in patients with certain types of EB. In this observational study, patients with either dystrophic EB (DEB) or junctional EB (JEB) will receive standard of care treatment, whether Filsuvez or something else, and will be followed for a minimum of 3 years. The main purpose is to see if the use of Filsuvez affects the likelihood of developing skin malignancies in these patient populations.

Study sites(12)

Lucile Packard Children's Hospital
Palo Alto, California, United States
Not yet recruiting
UCHealth / Children's Hospital Colorado
Aurora, Colorado, United States
Not yet recruiting
UF College of Medicine
Gainesville, Florida, United States
Not yet recruiting
Cincinnati Children's
Cincinnati, Ohio, United States
Not yet recruiting
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Not yet recruiting
Medical University of South Carolina
Charleston, South Carolina, United States
Not yet recruiting
CHU de Toulouse, Hôpital Larrey
Toulouse, France
Recruiting
UMC Freiburg EB Centre
Freiburg im Breisgau, Germany
Recruiting
Hospital of Skin and Venereal Diseases of Thessaloniki
Thessaloniki, Greece
Recruiting
Hospital Clinic, Barcelona
Barcelona, Spain
Recruiting
Hospital San Juan de Dios (Barcelona)
Barcelona, Spain
Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Recruiting

Showing 12 of 12 sites. 6 of the 12 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06423573. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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