ADHELASKIN for Systemic Sclerosis Skin Assessment (NCT07543679)
Summary
A clinical trial (NCT07543679) evaluating ADHELASKIN technology by Tactinnov and École Centrale de Lyon for objective assessment of skin damage in patients with systemic sclerosis has been registered on ClinicalTrials.gov. The trial addresses limitations of the modified Rodnan skin score (mRSS), including inter- and intra-observer variability and limited sensitivity to subtle changes. ADHELASKIN uses an indentation method with ruby-based measurement to quantify rigidity, firmness, and elasticity of skin with improved accuracy. The study will classify patients as diffuse cutaneous or limited cutaneous SSc based on skin fibrosis extent.
“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.”
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What changed
A new clinical trial has been registered on ClinicalTrials.gov for ADHELASKIN, a medical technology developed by Tactinnov and École Centrale de Lyon that enables objective measurement of skin rigidity, firmness, and elasticity through an indentation method. The trial targets patients with systemic sclerosis and aims to address known limitations of the standard modified Rodnan skin score assessment, including subjectivity in palpation and limited sensitivity to small changes.
Healthcare providers and clinical investigators involved in systemic sclerosis research should note this emerging alternative assessment tool. Patients with diffuse or limited cutaneous SSc may benefit from more quantitative and reproducible skin fibrosis measurement. The trial represents an advancement in efforts to develop validated objective tools for routine clinical assessment of cutaneous sclerosis.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis
N/A NCT07543679 Kind: NA Apr 22, 2026
Abstract
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 ...
Conditions: D013493
Interventions: ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)
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