Preparation of forearm molds with SILFLO® silicone
OtherPreparation of forearm molds with SILFLO® silicone (MONADERM, Monaco), CE-marked and already used routinely in dermocosmetics. These molds will, then, be analyzed.
NCT Number: NCT06945081
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.
Interested in participating?
Request Info12 year and older
All sexes
Interventional
Not applicable
Hospices Civils de Lyon, Bron, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Diseased patients :
Healthy volunteers :
All patients :
Exclusion criteria
All patients:
Preparation of forearm molds with SILFLO® silicone (MONADERM, Monaco), CE-marked and already used routinely in dermocosmetics. These molds will, then, be analyzed.
Time frame: At inclusion
Measurement of skin tension indices on a silicone cast of the inner forearm with a confocal laser expressed as a percentage (from 0 (perfect tension balance) to 100 (absolute imbalance on one tension axis)) of patients treated with D-Penicillamine and healthy patients.
Time frame: Year 1
Measurement of skin tension indices on silicone casts of the inner and outer forearm with confocal laser and comparison between different groups of patients according to duration of exposure to treatment in subgroups: (< to 5 years, 5 to 10 years, 10 to 15 years and 15 years and more).
Time frame: Year 1
Measurement of skin tension indices on various silicone casts of the inner and outer forearm and cheek with confocal laser and comparison between patients and age- and sex-matched control group patients
Contact information is provided by the study sponsor or research team.
Eduardo COUCHONNAL-BEDOYA, MD
CONTACT
(0)4 72 35 70 50 ext. +33
Jean Luc PERROT, PHD
CONTACT
(0)4 77 82 83 33 ext. +33
Centre Hospitalier Universitaire de Saint Etienne
Other
Acronym: WILDERME
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03334292
Basal Ganglia Diseases, Brain Diseases
New Haven, Connecticut, United States
View Trial DetailsNCT07301216
Basal Ganglia Diseases, Brain Diseases
New Haven, Connecticut, United States
View Trial DetailsNCT06650319
Basal Ganglia Diseases, Brain Diseases
Hangzhou, Zhejiang, China
View Trial DetailsNCT06430359
Basal Ganglia Diseases, Brain Diseases
Bron, Rhone, France
View Trial Details