Actively Recruiting

All Genders
NCT06423573

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

Led by Amryt Pharma · Updated on 2025-09-19

580

Participants Needed

5

Research Sites

397 weeks

Total Duration

On this page

Sponsors

A

Amryt Pharma

Lead Sponsor

C

Chiesi Farmaceutici S.p.A.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a confirmed diagnosis of dystrophic EB or junctional EB
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

CHU de Toulouse, Hôpital Larrey

Toulouse, France

Actively Recruiting

2

Hospital of Skin and Venereal Diseases of Thessaloniki

Thessaloniki, Greece

Actively Recruiting

3

Hospital Clinic, Barcelona

Barcelona, Spain

Actively Recruiting

4

Hospital San Juan de Dios (Barcelona)

Barcelona, Spain

Actively Recruiting

5

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Actively Recruiting

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Research Team

C

Chiesi Clinical Trials

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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