Measuring skin damage in systemic sclerosis with ADHELASKIN
Official title: Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis
Run by Centre Hospitalier Universitaire de Saint Etienne · NCT07543679 · Data updated 2026-11-12
ADHELASKIN will be tried to measure skin thickness and firmness in people with systemic sclerosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-Priest-en-Jarez, Pays de la Loire Region) |
| Status | Recruiting |
| Started | May 7, 2026 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | July 31, 2026 |
| Trial ID | NCT07543679 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 healthy patients: Patients without significant skin lesions who are outpatients or inpatients at a department of the Saint-Etienne University Hospital * For healthy volunteers: Volunteers without significant skin lesions who work at the Saint-Etienne University Hospital and whose participation in the study does not require any special travel 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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.