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Not yet recruiting Not applicable NCT07543679

Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis

No applicable phase (e.g. observational)
Conditions: D013493

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

trial.available_in: БГ
Overview
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 firmness or elasticity, and limited sensitivity to small changes or in areas that are not severely affected. The assessment of skin fibrosis therefore faces a lack of objective, quantitative tools that are easy to use in routine clinical practice. Certain alternatives have been evaluated (durometer, ultrasound, elastography, etc.), but none has yet been fully adopted or validated for measuring firmness, elasticity, and adhesion at different depths of the skin with good accuracy and reproducibility. ADHELASKIN° technology (by Tactinnov, LTDS / École Centrale de Lyon) enables objective, highly sensitive measurement of rigidity, firmness and elasticity using an indentation method with a ruby ball sensor. The objective of our study is to assess whether the ADHELASKIN device can differentiate between the biomechanical properties of healthy patients and those of patients with SSc.
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
Interventions
ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)
DEVICE
Locations 1
France (1)
CHU de Saint-Etienne
Saint-Priest-en-Jarez , Pays de la Loire Region
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
01.05.2027
Registry ID
NCT07543679
Source
clinicaltrials.gov
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