A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez
This study is investigating the link between epidermolysis bullosa (EB) and skin cancer. People with EB have very delicate skin that blisters easily because a protein called collagen doesn't form correctly. They are also at a much higher risk of developing skin cancers. The study focuses on those with dystrophic EB (DEB) or junctional EB (JEB). Researchers want to see if using a gel called Filsuvez, which helps heal skin sores, influences the chance of developing skin cancer. This is an observational study, meaning patients will receive their usual care, whether that includes Filsuvez or not. Participants will be followed for up to five years, with information collected on any skin cancers that develop.
At a glance
What is this study about?
This study aims to understand the connection between epidermolysis bullosa (EB) and the development of skin cancer. People with EB have extremely fragile skin that blisters very easily because a key building block called collagen isn't formed properly. Unfortunately, having EB also significantly increases a person's risk of developing various types of skin cancer.
The study is specifically looking at two forms of EB: dystrophic EB (DEB) and junctional EB (JEB). The main goal is to observe if a treatment called Filsuvez, which is a gel used to help heal skin sores in people with EB, has any effect on whether these patients develop skin cancer. It's important to know that this is an observational study, meaning patients will continue to receive their usual medical care, which might include Filsuvez or other treatments. Researchers will simply be watching and collecting information.
Over a period of up to five years, researchers will gather details about any skin cancers that develop in participants. This includes common types like squamous cell carcinoma (SCC), basal cell carcinoma (BCC), and malignant melanoma (MM). By comparing what happens to patients who use Filsuvez with those who don't, the study hopes to learn more about how this treatment might influence skin cancer risk in the long term for people living with EB.
Key takeaways
- This study observes skin cancer risk in people with certain types of EB.
- It aims to see if using Filsuvez gel affects this risk.
- Patients receive their usual medical care; no new treatments are given.
- Information will be collected from medical records over five years.
- The study includes people of all ages with dystrophic or junctional EB.
- Results could help improve understanding and care for EB patients.
Who may be eligible?
To take part in this study, you must have a confirmed diagnosis of either dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB). There are no age restrictions, so individuals of any age can be considered.
This study is open to both male and female patients.
There are no other specific reasons stated that would prevent someone from joining this study once they meet the diagnosis requirement.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have a confirmed diagnosis of dystrophic EB?
- Do I have a confirmed diagnosis of junctional EB?
- Am I open to my long-term medical information being reviewed for up to five years?
- Am I happy for my data to be collected from my medical records or existing EB databases?
What does participation involve?
If you take part in this study, you won't be given any new or specific treatments by the study team. Instead, you'll continue to receive your usual medical care for your EB, just as you normally would. This is an 'observational' study, which means the researchers will simply be gathering information about your health over time.
They will collect details about any skin cancers that might develop and whether you are using Filsuvez gel as part of your standard treatment. This information will come from your medical records at clinics in the UK or the EU, and potentially from existing EB patient registries. You will be followed for up to five years. The main commitment for you is allowing your medical information related to skin cancer development and treatment to be collected and reviewed by the study team over this time frame.
Potential risks and benefits
Locations (5)
- CHU de Toulouse, Hôpital LarreyVerified postcodeToulouse, France· Recruiting
- Hospital of Skin and Venereal Diseases of ThessalonikiVerified postcodeThessaloniki, Greece· Recruiting
- Hospital Clinic, BarcelonaVerified postcodeBarcelona, Spain· Recruiting
- Hospital San Juan de Dios (Barcelona)Verified postcodeBarcelona, Spain· Recruiting
- Guy's and St Thomas' NHS Foundation TrustVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is Filsuvez?
Filsuvez is a gel applied to the skin, used to help heal wounds and sores in people with certain types of epidermolysis bullosa.
Will I have to take new medicine or get extra tests?
No, you will not receive any new medicines or extra tests from this study. You'll continue with your usual medical care, and the researchers will observe your health.
How long will I be in the study?
Participants in this study will be followed for up to five years, with information collected over that period.
Where will the information come from?
Information will be taken from your medical records at clinics in the UK or EU, and from existing patient databases for EB.
Why is this study important?
This study is important because it could help us understand if Filsuvez affects the risk of skin cancer in people with EB, potentially improving long-term care.
How to find out more
Chiesi Clinical Trials
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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