Skin effects of D-penicillamine in people with Wilson disease
Official title: Wilson's Disease Treated With D-Penicillamine: Characterization of Skin Damage Secondary to Treatment by Measuring Skin Elasticity
Run by Centre Hospitalier Universitaire de Saint Etienne · NCT06945081 · Data updated 2026-11-12
This project will use silicone molds and confocal imaging to see if D-penicillamine changes skin elasticity in people with Wilson disease compared with matched healthy volunteers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 2 sites (Bron and 1 other locations) |
| Status | Recruiting |
| Started | November 28, 2025 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | January 23, 2026 |
| Trial ID | NCT06945081 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 12 or older with genetically confirmed Wilson disease who are currently treated with D-penicillamine, followed at the Wilson Disease Reference Center, and without other elastic tissue disorders are ideal candidates.
✕Probably not a fit
Patients not taking D-penicillamine, those with other skin treatments or lesions at the sampling sites, or those without genetic confirmation are unlikely to gain useful information from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will enroll people aged 12 and older with genetically confirmed Wilson disease who are treated with D-penicillamine and matched healthy volunteers. Silicone molds of the forearm (and cheek when applicable) will be made to capture skin micro-relief, and samples will be analyzed by confocal laser imaging to quantify elastic tissue changes. Participants with other known elastic tissue disorders, active topical treatments, or lesions at the sampling sites are excluded to avoid confounding. Results will compare skin elasticity measures between the D-penicillamine group and matched controls to characterize treatment-related elastopathy.
Why it matters
Potential benefit: If successful, the findings could clarify a specific skin side effect of D-penicillamine and help clinicians monitor or change treatment to reduce cutaneous damage.
How similar studies have gone: Using silicone molding and confocal imaging is established in dermatology for surface and microstructural analysis, but applying these methods specifically to D-penicillamine–related elastopathy in Wilson disease is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hospices Civils de Lyon
Bron, France Recruiting -
Hôpital Nord CHU de Saint-Étienne
Saint-Etienne, France Not yet recruiting
Study contacts
- Principal investigator: Jean-Luc Perrot, Phd — Service de Dermatologie, Hôpital Nord CHU de Saint-Étienne 42055 SAINT-ETIENNE Cedex 2
- Study coordinator: Jean Luc PERROT, PHD
- Email: j.luc.perrot@chu-st-etienne.fr
- Phone: (0)4 77 82 83 33
Similar studies
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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.