Assessing skin cancer risk in patients with Epidermolysis Bullosa using 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
This study is testing if using the topical gel Filsuvez can help reduce the risk of skin cancer in patients with Epidermolysis Bullosa.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 580 (estimated) |
| Sex | All |
| Sponsor | Amryt Pharma Industry-sponsored |
| Locations | 5 sites (Toulouse and 4 other locations) |
| Trial ID | NCT06423573 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with Epidermolysis Bullosa (EB), a condition that leads to fragile skin and a higher risk of skin cancers. Participants with dystrophic EB or junctional EB will receive standard care, which may include the topical gel Filsuvez, and will be monitored for up to five years. The study aims to determine if the use of Filsuvez influences the incidence of skin malignancies such as squamous cell carcinoma, basal cell carcinoma, and malignant melanoma. Data will be collected from clinical centers in the EU and UK, as well as existing EB registries.
Who should consider this trial
Good fit: Ideal candidates are patients with a confirmed diagnosis of dystrophic or junctional Epidermolysis Bullosa.
Not a fit: Patients without a diagnosis of dystrophic or junctional Epidermolysis Bullosa will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of Filsuvez in reducing skin cancer risk for patients with Epidermolysis Bullosa.
How similar studies have performed: While this study is observational, similar approaches in monitoring skin cancer incidence in EB patients have shown promise, though the specific use of Filsuvez in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a confirmed diagnosis of dystrophic EB or junctional EB Exclusion Criteria: * None
Where this trial is running
Toulouse and 4 other locations
- CHU de Toulouse, Hôpital Larrey — Toulouse, France (Recruiting)
- Hospital of Skin and Venereal Diseases of Thessaloniki — Thessaloniki, Greece (Recruiting)
- Hospital Clinic, Barcelona — Barcelona, Spain (Recruiting)
- Hospital San Juan de Dios (Barcelona) — Barcelona, Spain (Recruiting)
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Chiesi Clinical Trials
- Email: clinicaltrials_info@chiesi.com
- Phone: +3905212791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.