Assessing skin cancer risk in patients with Epidermolysis Bullosa using Filsuvez
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
Run by Chiesi Farmaceutici S.p.A. · NCT06423573 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 170 (estimated) |
| Sponsor | Chiesi Farmaceutici S.p.A. Industry-sponsored |
| Locations | 12 sites (Palo Alto, California and 11 other locations) |
| Status | Recruiting |
| Started | December 18, 2024 |
| Main results expected | November 30, 2031 |
| Study ends | August 1, 2032 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT06423573 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with a confirmed diagnosis of dystrophic or junctional Epidermolysis Bullosa.
✕Probably not a fit
Patients without a diagnosis of dystrophic or junctional Epidermolysis Bullosa will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a confirmed diagnosis of dystrophic EB or junctional EB Exclusion Criteria: * None
Where it's running
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CHU de Toulouse, Hôpital Larrey
Toulouse, France Recruiting -
UMC Freiburg EB Centre
Freiburg im Breisgau, Germany 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
Show 6 more locations
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Lucile Packard Children's Hospital
Palo Alto, California, United States Not yet recruiting -
UCHealth / Children's Hospital Colorado
Aurora, Colorado, United States Not yet recruiting -
UF College of Medicine
Gainesville, Florida, United States Not yet recruiting -
Cincinnati Children's
Cincinnati, Ohio, United States Not yet recruiting -
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States Not yet recruiting -
Medical University of South Carolina
Charleston, South Carolina, United States Not yet recruiting
Study contacts
- Study coordinator: Chiesi Clinical Trials
- Email: clinicaltrials_info@chiesi.com
- Phone: +3905212791
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Oleogel-S10 gel for healing skin wounds in Japanese patients with epidermolysis bullosa.
We will try Oleogel‑S10 gel to see if it closes or shrinks wounds in Japanese children and adults with junctional or dystrophic epidermolysis bullosa.
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Energy-F703EB Cream for Epidermolysis Bullosa: a skin cream test in adults
This phase 2 study tests ENERGI-F703EB Cream versus a matching vehicle to see if it is safe and helps small EB skin lesions in adults.
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KB803 eye drops versus placebo for people with dystrophic epidermolysis bullosa
This trial tests whether KB803 eye drops, given three times a week, can reduce recurrent corneal abrasions in children and adults with dystrophic epidermolysis bullosa.
-
Using IV immunoglobulin to lower collagen VII antibodies in dystrophic epidermolysis bullosa
This trial tests whether IV immunoglobulin given to people with recessive dystrophic epidermolysis bullosa who are on VYJUVEK helps wounds heal faster and lowers collagen VII and HSV‑1 antibody levels.
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This trial tests whether applying TCP-25 gel to matched skin wounds helps improve healing in children and adults with dystrophic or junctional epidermolysis bullosa.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.