Clinical trial · Observational
A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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 a minimum of 3 years. The main purpose is to see if the use of Filsuvez affects the likelihood of developing skin malignancies in these patient populations.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epidermolysis Bullosa, Dystrophic | — | UNRESOLVED | — |
| Epidermolysis Bullosa, Junctional | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Filsuvez | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients with dystrophic or junctional EB being treated with Filsuvez
- description
- Patients in this cohort will be receiving treatment with Filsuvez for their EB.
- interventionNames
- Drug: Filsuvez
- label
- Patients with dystrophic or junctional EB not being treated with Filsuvez
- description
- Patients in this cohort will be receiving treatment other than Filsuvez or no treatment at all for their EB.
Primary outcomes (1)
- measure
- Incidence of first skin malignancy during follow-up in EB patients receiving Filsuvez
- timeFrame
- Minimum 3 years
- description
- Patients being treated with Filsuvez will be followed for occurrence of skin malignancies from the date of study enrolment until either the date of discontinuation (withdrawal of consent, withdrawal from the site or registry, physician decision, death, or lost to follow-up) or termination of the study
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with a confirmed diagnosis of dystrophic EB or junctional EB Exclusion Criteria: * None
References
Publications (0)
Data not yet available