NCT06945081 Wilson's Disease Treated With D-Penicillamine: Characterization of Skin Damage Secondary to Treatment by Measuring Skin Elasticity
| NCT ID | NCT06945081 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Wilson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-11-28 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-11-28 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
JEAN-LUC PERROT, PHD
PRINCIPAL INVESTIGATOR
Service de Dermatologie, Hôpital Nord CHU de Saint-Étienne 42055 SAINT-ETIENNE Cedex 2
Frequently Asked Questions
Who can join the NCT06945081 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Wilson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06945081 currently recruiting?
Yes, NCT06945081 is actively recruiting participants. Contact the research team at j.luc.perrot@chu-st-etienne.fr for enrollment information.
Where is the NCT06945081 trial being conducted?
This trial is being conducted at Bron, France, Saint-Etienne, France.
Who is sponsoring the NCT06945081 clinical trial?
NCT06945081 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is JEAN-LUC PERROT, PHD at Service de Dermatologie, Hôpital Nord CHU de Saint-Étienne 42055 SAINT-ETIENNE Cedex 2. The trial plans to enroll 120 participants.