Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423573
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-16
Brief Title:
A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez
Sponsor:
Amryt Pharma
Organization:
Amryt Pharma
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOSteR
Brief 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
Detailed Description:
Some forms of EB are associated with a greatly increased incidence of aggressive skin and mucosal squamous cell carcinoma SCC as well as increased incidence of other skin malignancies including basal cell carcinoma BCC and malignant melanoma MM This long-term non-interventional study will assess all types of skin malignancies SCC BCC and MM in DEB and JEB patients It is an observational study of real-world treatment practices in which patients will receive standard of care therapy whatever that may entail Data will be obtained from two sources clinical study centers in the European Union EU and the United Kingdom UK and pre-existing EB registries in the EU Participants will be followed for up to 5 years and information about the development and nature of skin malignancies will be collected over this time period both from patients who are taking and those who are not taking Filsuvez
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None