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.
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
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
Parallel
ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)
DeviceEvaluation of stiffness, elastic modulus and pile-up height for ScS patients and controls by ADHELASKIN device
Objectively compare skin stiffness in patients with systemic sclerosis versus healthy patients
General comparison of average stiffness values in Newtons per meter obtained using the ADHELASKIN device on all areas examined between affected and healthy patients
Compare skin stiffness in different areas in patients with systemic sclerosis vs. healthy patients
Overall comparison of the sums and local averages and sums of the stiffness ( Newtons per meter) measured by the ADHELASKIN device on all areas explored between affected and healthy patients
Objectively compare skin elasticity in patients with systemic sclerosis vs. healthy patients.
Comparison of the overall and local averages and sums of the elasticity values measured by the ADHELASKIN device in kilopascals (kPA)
Objectively compare skin firmness in patients with systemic sclerosis vs. healthy patients.
Comparison of overall and local averages and sums of firmness values measured by the ADHELASKIN device in micrometers (μm)
Evaluate an association between the stiffness, elasticity, and firmness measurements obtained using the ADHELASKIN device and the mRSS score.
Correlation between skin thickening measured using the mRSS score by a trained investigator and biomechanical measurements of the skin measured by ADHELASKIN
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