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RecruitingNAINTERVENTIONAL

Wilson's Disease Treated With D-Penicillamine: Characterization of Skin Damage Secondary to Treatment by Measuring Skin Elasticity

This study is investigating how a medicine called D-Penicillamine, used for Wilson's disease, might affect the skin. Wilson's disease is a genetic condition where too much copper builds up in the body, which can harm organs like the liver and brain. D-Penicillamine helps remove this extra copper, but it can also cause skin issues. Researchers want to better understand these skin changes. They will gently take a mould of a small area of skin from people with Wilson's disease who are taking D-Penicillamine and compare it to moulds from healthy volunteers. This will help them learn more about how the medicine might change skin elasticity, which could lead to better ways to manage treatment in the future.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrolment target
120
Start
28 Nov 2025
Estimated completion
01 Jun 2026

What is this study about?

Wilson's disease is a condition inherited through families where the body has trouble getting rid of copper. This means copper can build up in places like the liver, brain, and eyes, which can cause health problems over time. A common treatment for Wilson's disease is a medicine called D-Penicillamine. This medicine works by helping your body get rid of the extra copper.

While D-Penicillamine is very important for treating Wilson's disease, it can sometimes cause side effects, particularly with the skin. Scientists don't fully understand why these skin changes happen and how exactly the medicine affects the skin's flexibility or 'elasticity'. This study aims to gather more information about these skin effects.

To do this, researchers will look closely at the skin of people with Wilson's disease who are taking D-Penicillamine. They will compare this to the skin of healthy people who don't have the condition. By understanding these skin changes better, doctors might be able to find ways to reduce these side effects or tailor treatments more effectively for patients in the future.

Key takeaways

  • Study aims to understand D-Penicillamine's effect on skin.
  • Compares skin of Wilson's patients to healthy volunteers.
  • Involves a gentle skin moulding procedure on the forearm.
  • No new medication given; continues existing treatment.
  • Results could lead to better management of skin side effects.

Who may be eligible?

To join this study, you would need to be at least 12 years old. If you have Wilson's disease, it must have been confirmed by a genetic test, and you should be receiving care at the Wilson's Disease Reference Center and currently taking D-Penicillamine. It's also important that you don't have any other known skin conditions that affect skin flexibility.

For healthy volunteers, you would also need to be at least 12 years old and be attending the dermatology department at St Etienne University Hospital for your care. We would try to match you by age and sex with someone who has Wilson's disease. Like the other group, you should not have any skin conditions that affect flexibility.

For everyone taking part, you need to be covered by national health insurance and be able to provide written permission (consent) to participate. You wouldn't be able to join if you are pregnant or breastfeeding, unable to follow instructions, or if you have any skin problems or are using certain creams on the areas being studied.

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.

  1. Are you 12 years old or older?
  2. If you have Wilson's disease, is it confirmed by a genetic test and are you taking D-Penicillamine?
  3. Do you have national health insurance?
  4. Are you able to give written permission to take part?
  5. Do you have no other skin conditions affecting flexibility, or active skin problems on your forearm or cheek?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main step involves a simple, gentle procedure. Researchers will make a small, temporary mould of a small area of skin on your forearm using a soft silicone material called SILFLO®. This process is painless and safe. It will help them get a detailed impression of your skin's surface. There won't be any medication given as part of the study itself, as they are looking at the effects of the D-Penicillamine you are already taking. The study involves a one-time visit for this procedure. The exact total duration of the study for you would likely be just that single visit.

Potential risks and benefits

Taking part in this study may help researchers better understand how D-Penicillamine affects the skin in people with Wilson's disease, which could lead to improved care in the future. The risks of participating are very low; making a silicone mould of your skin is a safe and gentle procedure. You might feel a slight, temporary sensation when the mould is applied and removed. It's important to remember that you are free to change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

  • Hospices Civils de Lyon
    Verified postcode
    Bron, France· Recruiting
  • Hôpital Nord CHU de Saint-Étienne
    Verified postcode
    Saint-Etienne, France· Not yet recruiting

Common questions

What is Wilson's disease?

It's a genetic condition where your body can't remove enough copper, causing it to build up and potentially harm organs.

What is D-Penicillamine?

It's a medicine commonly used for Wilson's disease that helps your body get rid of the extra copper.

What will happen during the study?

A soft, harmless silicone mould will be made of a small area of skin on your forearm to study its surface.

Will I have to stop my D-Penicillamine?

No, the study is looking at people who are already taking D-Penicillamine, you will continue your usual treatment.

Is the skin mould painful?

No, making the silicone mould is a gentle and painless procedure.

How to find out more

Jean Luc PERROT, PHD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Wilson's Disease Treated With D-Penicillamine: Characterizat…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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