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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

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

Locations
Other Locations
France
CHU de Toulouse, Hôpital Larrey
RECRUITING
Toulouse
Greece
Hospital of Skin and Venereal Diseases of Thessaloniki
RECRUITING
Thessaloniki
Spain
Hospital Clinic, Barcelona
RECRUITING
Barcelona
Hospital San Juan de Dios (Barcelona)
RECRUITING
Barcelona
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Chiesi Clinical Trials
clinicaltrials_info@chiesi.com
+3905212791
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2032-08-01
Participants
Target number of participants: 580
Treatments
Patients with dystrophic or junctional EB being treated with Filsuvez
Patients in this cohort will be receiving treatment with Filsuvez for their EB.
Patients with dystrophic or junctional EB not being treated with Filsuvez
Patients in this cohort will be receiving treatment other than Filsuvez or no treatment at all for their EB.
Sponsors
Collaborators: Chiesi Farmaceutici S.p.A.
Leads: Amryt Pharma

This content was sourced from clinicaltrials.gov