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A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez
Sponsor: Amryt Pharma
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.
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
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
580
Start Date
2024-12-18
Completion Date
2032-08-01
Last Updated
2025-09-19
Healthy Volunteers
No
Interventions
Filsuvez
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