Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis (OBSKINS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lucile GRANGE, MD
- Phone Number: +33 (0)4 77 82 83 42
- Email: Lucile.GRANGE@chu-st-etienne.fr
Study Contact Backup
- Name: Clara PFENNINGER, PhD
- Phone Number: +33 (0)477120287
- Email: clara.pfenninger@chu-st-etienne.fr
Study Locations
-
-
Pays de la Loire Region
-
Saint-Priest-en-Jarez, Pays de la Loire Region, France, 42270
- Recruiting
- CHU de Saint-Etienne
-
Contact:
- Lucile GRANGE, MD
- Phone Number: +33 (0)4 77 82 83 42
- Email: Lucile.GRANGE@chu-st-etienne.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ScS patients
Patients with SSc according to the 2013 ACR/EULAR criteria
|
Evaluation of stiffness, elastic modulus and pile-up height for ScS patients and controls by ADHELASKIN device
|
|
Experimental: Control group
Patients without significant skin involvement
|
Evaluation of stiffness, elastic modulus and pile-up height for ScS patients and controls by ADHELASKIN device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objectively compare skin stiffness in patients with systemic sclerosis versus healthy patients
Time Frame: Day 1
|
General comparison of average stiffness values in Newtons per meter obtained using the ADHELASKIN device on all areas examined between affected and healthy patients
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compare skin stiffness in different areas in patients with systemic sclerosis vs. healthy patients
Time Frame: Day 1
|
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
|
Day 1
|
|
Objectively compare skin elasticity in patients with systemic sclerosis vs. healthy patients.
Time Frame: Day 1
|
Comparison of the overall and local averages and sums of the elasticity values measured by the ADHELASKIN device in kilopascals (kPA)
|
Day 1
|
|
Objectively compare skin firmness in patients with systemic sclerosis vs. healthy patients.
Time Frame: Day 1
|
Comparison of overall and local averages and sums of firmness values measured by the ADHELASKIN device in micrometers (μm)
|
Day 1
|
|
Evaluate an association between the stiffness, elasticity, and firmness measurements obtained using the ADHELASKIN device and the mRSS score.
Time Frame: Day 1
|
Correlation between skin thickening measured using the mRSS score by a trained investigator and biomechanical measurements of the skin measured by ADHELASKIN
|
Day 1
|
|
Estimate the patient experience of skin assessment using ADHELASKIN
Time Frame: Day 1
|
Standardized patient experience questionnaire in ScS and healthy patients.
|
Day 1
|
|
Estimate inter-investigator variability in stiffness measurement using ADHELASKIN
Time Frame: Day 1
|
Measurement of stiffness in N/m on a small cohort of 10 patients by 2 investigators using ADHELASKIN
|
Day 1
|
|
Compare the duration of skin stiffness measurement examinations of 17 body regions by mRSS score and using ADHELASKIN
Time Frame: Day 1
|
Measurement of the duration of the mRSS examination on the 17 regions and using the ADHELASKIN device on these same regions on 10 patients by a trained investigator
|
Day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lucile GRANGE, MD, Centre Hospitalo-Universitaire de Saint-Etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26CH041
- ANSM (Other Identifier: 2025-A02921-48)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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