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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAmryt Pharma

About this trial

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 criteria

Qualifiers

Patients with a confirmed diagnosis of dystrophic EB or junctional EB

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Filsuvez

Treatment groups

580 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Amryt Pharma

Lead sponsor

Chiesi Farmaceutici S.p.A.

Collaborator