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NCT Number: NCT06945081

Wilson's Disease Treated With D-Penicillamine: Characterization of Skin Damage Secondary to Treatment by Measuring Skin Elasticity

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preparation of forearm molds with SILFLO® silicone

Other

Preparation of forearm molds with SILFLO® silicone (MONADERM, Monaco), CE-marked and already used routinely in dermocosmetics. These molds will, then, be analyzed.

Primary outcomes

  1. Skin tension measurement

    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.

Secondary outcomes

  1. Skin tension indices measurement on silicone casts

    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).

  2. Skin tension indice measurement with confocal laser

    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

Study contacts

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

[email protected]

(0)4 77 82 83 33 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: WILDERME

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2025
Registry last updated
Jan 23, 2026

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.

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