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

NCT06423573 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 580

Last updated 2025-09-19

No results posted yet for this study

Summary

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 up to 5 years. The main purpose is to see if the use of Filsuvez affects the likelihood of developing skin malignancies in these patient populations.

Conditions

  • Epidermolysis Bullosa, Dystrophic
  • Epidermolysis Bullosa, Junctional

Interventions

DRUG

Filsuvez

Topical gel

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    collaborator INDUSTRY

  • Amryt Pharma

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-18
Primary Completion
2031-11-30
Completion
2032-08-01

Countries

  • France
  • Greece
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06423573 on ClinicalTrials.gov