Skin effects of D-penicillamine in people with Wilson disease
Wilson's Disease Treated With D-Penicillamine: Characterization of Skin Damage Secondary to Treatment by Measuring Skin Elasticity
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 2 sites (Bron and 1 other locations) |
| Trial ID | NCT06945081 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bron and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.