RecruitingNCT06423573

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


Sponsor

Amryt Pharma

Enrollment

580 participants

Start Date

Dec 18, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Inclusion Criteria1

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

Exclusion Criteria1

  • None

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Interventions

DRUGFilsuvez

Topical gel


Locations(5)

CHU de Toulouse, Hôpital Larrey

Toulouse, France

Hospital of Skin and Venereal Diseases of Thessaloniki

Thessaloniki, Greece

Hospital Clinic, Barcelona

Barcelona, Spain

Hospital San Juan de Dios (Barcelona)

Barcelona, Spain

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

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NCT06423573


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