Wilson's Disease Treated With D-Penicillamine: Characterization of Skin Damage Secondary to Treat… (NCT06945081) | Clinical Trial Compass
RecruitingNot Applicable
Wilson's Disease Treated With D-Penicillamine: Characterization of Skin Damage Secondary to Treatment by Measuring Skin Elasticity
France120 participantsStarted 2025-11-28
Plain-language summary
Wilson's disease is a genetic disorder, resulting from an anomaly present on the ATP7B gene located on chromosome 13, causing a progressive accumulation of copper in various organs such as the liver, nervous system and cornea, leading to various hepatic and neurological disorders and a systemic evolution.
Currently, the first-line treatment for this disease is D-Penicillamine, which acts by chelation and promotes copper excretion through the urine. Unfortunately, this treatment also has significant side-effects, particularly on the skin. However, the pathogenesis of elastopathy in patients with Wilson's disease has yet to be fully characterized, and needs to be better understood in order to adapt the therapeutic strategy.
A silicon mold will be made on Wilson's disease patients, enabling the skin micro-relief to be shaped, and analyzed by confocal laser in comparison with the skin of healthy volunteers.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Diseased patients :
* Patient over 12 years old
* Patient with Wilson's disease confirmed by genetic analysis
* Patient followed up in the Wilson's Disease Reference Center for his care
* Patient treated with D-Penicillamine
* Patient with no other known elastic tissue pathology
Healthy volunteers :
* Patient over 12 years old
* Patient followed up in the dermatology department of St Etienne University Hospital
* Patient matched on sex and age with a patient from the "Wilson's disease" group
* Patient with no elastic tissue pathology
All patients :
* Patient affiliated to a national social security
* Patient with written informed consent
Exclusion Criteria:
All patients:
* Patient not taking a treatment (at investigator's discretion) that may modify skin elasticity
* Patient with pathological lesion(s) on forearm or cheek
* Patient with a potentially active/rejuvenative forearm or cheek treatment
* Patient having applied cream and/or make-up to the areas to be molded (forearm and cheek)
* Patient under guardianship
* Patient unable to follow study procedures
* Pregnant or breast-feeding women
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Skin tension measurement
Timeframe: At inclusion
Trial details
NCT IDNCT06945081
SponsorCentre Hospitalier Universitaire de Saint Etienne