Wilson DiseaseWILDERMENCT06945081
Wilson's Disease Treated With D-Penicillamine: Characterization of Skin Damage Secondary to Treatment by Measuring Skin Elasticity
A study testing Preparation of forearm molds with SILFLO® silicone in people with Wilson Disease and D-Penicillamine, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wilson Disease, D-Penicillamine, Effect of D-penicilline on Cutaneous Elastity of Wilson's Patient
- What is being tested?
- Preparation of forearm molds with SILFLO® silicone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Nov 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Eduardo COUCHONNAL-BEDOYA, MD contact
France2 sites, 2 recruiting
- Recruiting
Hospices Civils de Lyon
Bron, 69677
Eduardo COUCHONNAL-BEDOYA, MD, (0)4 27 35 70 50 ext. +33, eduardo.couchonnal-bedoya@chu-lyon.fr
- Not yet recruiting
Hôpital Nord CHU de Saint-Étienne
Saint-Etienne, 42055
JEAN-LUC PERROT, PHD, (0)4 77 82 83 33 ext. +33, j.luc.perrot@chu-st-etienne.fr
About this study
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.
- Conditions
- Wilson Disease, D-Penicillamine, Effect of D-penicilline on Cutaneous Elastity of Wilson's Patient
- Being tested
- Preparation of forearm molds with SILFLO® silicone
- Keywords
- Cutaneous elastopathy
- Medical subject headings
- Hepatolenticular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preparation of forearm molds with SILFLO® siliconeOther
Preparation of forearm molds with SILFLO® silicone (MONADERM, Monaco), CE-marked and already used routinely in dermocosmetics. These molds will, then, be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| D-penicillamine | Experimental | Patients with Wilson's disease treated with D-penicillamine for various exposure times Receives: Other: Preparation of forearm molds with SILFLO® silicone |
| Healthy patients | Active comparator | Patients not diagnosed with wilson's disease and not receiving treatment that may affect skin elasticity Receives: Other: Preparation of forearm molds with SILFLO® silicone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin tension measurement
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.
Measured: At inclusion
Secondary outcomes (2)
Skin tension indices measurement on silicone casts
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).
Measured: Year 1
Skin tension indice measurement with confocal laser
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
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start28 Nov 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilson DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory, prospective, matched-control study. Cohort of Wilson's disease patients undergoing treatment with D-Penicillamine matched for age and sex to a control patient, as we know that skin elasticity is modified according to the patient's age and sex. This will enable us to study primarily the effect of treatment and its duration, although we know that other factors may come into play (sun exposure, smoking/alcohol consumption, etc.). Characterization of cutaneous side-effects of treatment by measuring skin tension lines (using a silicone mold on a small part of the skin of the forearm and cheek, enabling precise measurement of the tension lines, reproduced in these molds, by a confocal laser).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JEAN-LUC PERROT, PHD, Principal investigator, Service de Dermatologie, Hôpital Nord CHU de Saint-Étienne 42055 SAINT-ETIENNE Cedex 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945081
- Sponsor's protocol ID
- 25CH057
- Other IDs
- ANSM
- Acronym
- WILDERME
- Status last verified
- Jan 2026
- First submitted
- 18 Apr 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wilson's Disease Treated With D-Penicillamine: Characterization of Skin Damage Secondary to Treatment by Measuring Skin Elasticity
- ClinicalTrials.gov ID
- NCT06945081
- Acronym / sponsor ID
- WILDERME / 25CH057
- Conditions
- Wilson Disease, D-Penicillamine, Effect of D-penicilline on Cutaneous Elastity of Wilson's Patient
- Keywords
- Cutaneous elastopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Exploratory, prospective, matched-control study. Cohort of Wilson's disease patients undergoing treatment with D-Penicillamine matched for age and sex to a control patient, as we know that skin elasticity is modified according to the patient's age and sex. This will enable us to study primarily the effect of treatment and its duration, although we know that other factors may come into play (sun exposure, smoking/alcohol consumption, etc.). Characterization of cutaneous side-effects of treatment by measuring skin tension lines (using a silicone mold on a small part of the skin of the forearm and cheek, enabling precise measurement of the tension lines, reproduced in these molds, by a confocal laser).
| Arm | Type | Receives |
|---|---|---|
| D-penicillamine | Experimental | Other: Preparation of forearm molds with SILFLO® siliconePatients with Wilson's disease treated with D-penicillamine for various exposure times |
| Healthy patients | Active comparator | Other: Preparation of forearm molds with SILFLO® siliconePatients not diagnosed with wilson's disease and not receiving treatment that may affect skin elasticity |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preparation of forearm molds with SILFLO® siliconePreparation of forearm molds with SILFLO® silicone (MONADERM, Monaco), CE-marked and already used routinely in dermocosmetics. These molds will, then, be analyzed. | Other | D-penicillamine, Healthy patients |
Primary outcome
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.
2 secondary outcomes
Skin tension indices measurement on silicone casts
Time frame: Year 1
Skin tension indice measurement with confocal laser
Time frame: Year 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eduardo COUCHONNAL-BEDOYA, MD contact
JEAN-LUC PERROT, PHD principal investigator
Service de Dermatologie, Hôpital Nord CHU de Saint-Étienne 42055 SAINT-ETIENNE Cedex 2
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preparation of forearm molds with SILFLO® silicone in people with Wilson Disease and D-Penicillamine, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Luc PERROT, PHD ((0)4 77 82 83 33 ext. +33, j.luc.perrot@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin tension measurement (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.