Measuring skin damage in systemic sclerosis with ADHELASKIN
Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis
ADHELASKIN will be tried to measure skin thickness and firmness in people with systemic sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-Priest-en-Jarez, Pays de la Loire Region) |
| Trial ID | NCT07543679 on ClinicalTrials.gov |
What this trial studies
Adults with systemic sclerosis and control participants without significant skin involvement will undergo objective skin measurements using the ADHELASKIN device at standard anatomical sites. Device-derived metrics will be compared with the modified Rodnan skin score (mRSS) obtained by clinical palpation to determine reproducibility, sensitivity, and agreement with clinical scoring. The single-center study is conducted at CHU de Saint-Etienne and requires informed consent and routine eligibility screening. Key exclusions include other inflammatory or scarring dermatoses and individuals unable to provide consent due to legal protection or incapacity.
Who should consider this trial
Good fit: Adults who meet the 2013 ACR/EULAR criteria for systemic sclerosis and can give informed consent are eligible, along with control volunteers who lack significant skin involvement.
Not a fit: People with unrelated inflammatory or scarring skin conditions, those legally unable to consent, or those hospitalized without consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, ADHELASKIN could provide a more objective and reproducible way to track skin fibrosis and detect subtle changes in people with systemic sclerosis.
How similar studies have performed: Other device-based approaches such as ultrasound and durometry have shown promise for objective skin measurement, but device use for routine SSc skin scoring remains relatively novel and not yet widely adopted.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients affiliated with or eligible for social security * Patients who have received informed consent about the study and have co-signed, with the investigator, a consent form to participate in the study * For case patients: Patients with SSc according to the 2013 ACR/EULAR criteria * For control patients: Patients without significant skin involvement Exclusion Criteria: * Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than research; * Adults subject to legal protection measures (guardianship-curatorship) or unable to express their consent * Inflammatory or scarring dermatoses in different individuals
Where this trial is running
Saint-Priest-en-Jarez, Pays de la Loire Region
- CHU de Saint-Etienne — Saint-Priest-en-Jarez, Pays de la Loire Region, France (Recruiting)
Study contacts
- Principal investigator: Lucile GRANGE, MD — Centre hospitalo-universitaire de Saint-Etienne
- Study coordinator: Lucile GRANGE, MD
- Email: Lucile.GRANGE@chu-st-etienne.fr
- Phone: (0)4 77 82 83 42
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.