Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis
Systemic sclerosis (SSc) is an autoimmune disease characterized by skin fibrosis, which clinically manifests as thickening, hardening, and loss of elasticity of the skin. Patients are typically classified as having diffuse cutaneous SSc (dcSSc) or limited cutaneous SSc (lcSSc) depending on the extent of skin fibrosis.
| Condition(s) | D013493 |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Systemic sclerosis (SSc) is an autoimmune disease characterized by skin fibrosis, which clinically manifests as thickening, hardening, and loss of elasticity of the skin. Patients are typically classified as having diffuse cutaneous SSc (dcSSc) or limited cutaneous SSc (lcSSc) depending on the extent of skin fibrosis. The standard assessment of cutaneous sclerosis is based on the modified Rodnan skin score (mRSS), which consists of clinical palpation of 17 areas of the body, scored from 0 (normal) to 3 (severe sclerosis) for each area, with a total of 51 points. However, the mRSS has several limitations, including high inter- and intra-observer variability, particularly depending on the clinician's experience, subjectivity of palpation with difficulties in quantifying subtle changes in fir |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Locations | Saint-Priest-en-Jarez, Pays de la Loire Region, France |
| Start date | 2026-05-07 |
| NCT ID | NCT07543679 |
| Official listing | https://clinicaltrials.gov/study/NCT07543679 |