Actively Recruiting
Wilson's Disease Treated With D-Penicillamine: Characterization of Skin Damage Secondary to Treatment by Measuring Skin Elasticity
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2026-01-23
120
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Wilson's disease is a genetic condition caused by a mutation in the ATP7B gene, leading to harmful copper buildup in organs like the liver, nervous system, and eyes. This buildup causes liver and neurological problems. The usual treatment is D-Penicillamine, which helps remove copper through urine but can cause skin side effects. The exact cause of skin damage in these patients is not fully understood and needs more study to improve treatment approaches. Researchers are studying skin damage in Wilson's disease patients treated with D-Penicillamine by making silicone molds of the skin's surface on patients' forearms. These molds will be analyzed using confocal laser technology and compared to those from healthy volunteers. The study includes two groups: patients with Wilson's disease on D-Penicillamine and healthy individuals matched by age and sex. Participants will have skin tension measured at the start of the study and again after one year using silicone casts and confocal laser methods. The study involves preparation of forearm molds with a special silicone product. Researchers will monitor skin elasticity changes over time and compare findings between treated patients and healthy controls. The total duration includes initial measurements and follow-up at one year to assess skin condition changes.
CONDITIONS
Brief Title
Wilson's Disease Treated With D-Penicillamine: Characterization of Skin Damage Secondary to Treatment by Measuring Skin Elasticity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 12 years or older
- Confirmed diagnosis of Wilson's disease by genetic analysis
- Currently treated with D-Penicillamine
- Followed at the Wilson's Disease Reference Center
- No known elastic tissue disorders other than Wilson's disease
- For healthy volunteers: aged 12 years or older
- Matched by age and sex to a Wilson's disease patient
- Followed at the dermatology department of St Etienne University Hospital
- No elastic tissue disorders
- Affiliated with national social security
- Provided written informed consent
You will not qualify if you...
- Taking treatments that may alter skin elasticity (at investigator's discretion)
- Pathological lesions on the forearm or cheek
- Active or rejuvenative treatments on forearm or cheek
- Applied cream or make-up on areas to be molded
- Under legal guardianship
- Unable to follow study procedures
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At inclusion
Participants undergo preparation of forearm molds with SILFLO® silicone to characterize skin damage secondary to treatment by measuring skin elasticity.
1 visit (in-person)
Duration - 1 year
Participants return for skin tension indices measurements on silicone casts and with confocal laser to monitor skin changes.
1 visit at Year 1
Trial Site Locations
Total: 2 locations
1
Hospices Civils de Lyon
Bron, France, 69677
Actively Recruiting
2
Hôpital Nord CHU de Saint-Étienne
Saint-Etienne, France, 42055
Not Yet Recruiting
Research Team
J
Jean Luc PERROT, PHD
E
Eduardo COUCHONNAL-BEDOYA, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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