Clinical trial Recruiting at 6 sites Observational

Assessing skin cancer risk in patients with Epidermolysis Bullosa using Filsuvez

Official title: 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

Run by Chiesi Farmaceutici S.p.A. · NCT06423573 · Data updated 2026-11-12

This study is testing if using the topical gel Filsuvez can help reduce the risk of skin cancer in patients with Epidermolysis Bullosa.

More Dystrophic Epidermolysis Bullosa trials

Quick facts

Study typeObservational
SexAll
Enrollment170 (estimated)
SponsorChiesi Farmaceutici S.p.A.
Industry-sponsored
Locations12 sites (Palo Alto, California and 11 other locations)
StatusRecruiting
StartedDecember 18, 2024
Main results expectedNovember 30, 2031
Study endsAugust 1, 2032
Registry record updatedSeptember 28, 2026
Trial IDNCT06423573 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with a confirmed diagnosis of dystrophic or junctional Epidermolysis Bullosa.

Probably not a fit

Patients without a diagnosis of dystrophic or junctional Epidermolysis Bullosa will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with Epidermolysis Bullosa (EB), a condition that leads to fragile skin and a higher risk of skin cancers. Participants with dystrophic EB or junctional EB will receive standard care, which may include the topical gel Filsuvez, and will be monitored for up to five years. The study aims to determine if the use of Filsuvez influences the incidence of skin malignancies such as squamous cell carcinoma, basal cell carcinoma, and malignant melanoma. Data will be collected from clinical centers in the EU and UK, as well as existing EB registries.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of Filsuvez in reducing skin cancer risk for patients with Epidermolysis Bullosa.

How similar studies have gone: While this study is observational, similar approaches in monitoring skin cancer incidence in EB patients have shown promise, though the specific use of Filsuvez in this context is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

* None

Where it's running

  • 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
Show 6 more locations
  • 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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.