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

NCT ID: NCT06423573

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

580 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-18

Study Completion Date

2032-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epidermolysis Bullosa, Dystrophic Epidermolysis Bullosa, Junctional

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with dystrophic or junctional EB being treated with Filsuvez

Patients in this cohort will be receiving treatment with Filsuvez for their EB.

Filsuvez

Intervention Type DRUG

Topical gel

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.

No interventions assigned to this group

Interventions

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Filsuvez

Topical gel

Intervention Type DRUG

Other Intervention Names

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Birch bark extract

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role collaborator

Amryt Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Toulouse, Hôpital Larrey

Toulouse, , France

Site Status RECRUITING

Hospital of Skin and Venereal Diseases of Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

Hospital Clinic, Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital San Juan de Dios (Barcelona)

Barcelona, , Spain

Site Status RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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France Greece Spain United Kingdom

Central Contacts

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Chiesi Clinical Trials

Role: CONTACT

[email protected]
+3905212791

Facility Contacts

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Juliette Mazereeuw Hautier

Role: primary

[email protected]
33 5 67 77 18 76

Dimitra Kiritsi

Role: primary

[email protected]
0030-6983375771

Josep Riera Monroig

Role: primary

[email protected]
93 227 54 00

Asuncion Vicente

Role: primary

[email protected]

Jemima Mellerio

Role: primary

[email protected]
44 20 7188 6399

Other Identifiers

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AEB-21

Identifier Type: -

Identifier Source: org_study_id

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