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

NCT07543679 | Not Yet Recruiting

• 2 other identifiers: 26CH041ANSM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

D013493

Keywords

Systemic sclerosis; firmness; skin evaluation; Rodnan score; mRSS

Outcome Measures

Primary Outcomes (1)

• 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

  Day 1

Secondary Outcomes (7)

• Compare skin stiffness in different areas in patients with systemic sclerosis vs. healthy patients

  Day 1

• Objectively compare skin elasticity in patients with systemic sclerosis vs. healthy patients.

  Day 1

• Objectively compare skin firmness in patients with systemic sclerosis vs. healthy patients.

  Day 1

• Evaluate an association between the stiffness, elasticity, and firmness measurements obtained using the ADHELASKIN device and the mRSS score.

  Day 1

• Estimate the patient experience of skin assessment using ADHELASKIN

  Day 1

Study Arms (2)

ScS patients

EXPERIMENTAL

Patients with SSc according to the 2013 ACR/EULAR criteria

Device: ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)

Control group

EXPERIMENTAL

Patients without significant skin involvement

Device: ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)

Interventions

ADHELASKIN (Tactinnov° - Ecole centrale de Lyon) DEVICE

Evaluation of stiffness, elastic modulus and pile-up height for ScS patients and controls by ADHELASKIN device

Control group; ScS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Priest-en-Jarez, Pays de la Loire Region, 42270, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Lucile GRANGE, MD

  Centre hospitalo-universitaire de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucile GRANGE, MD

CONTACT

(0)4 77 82 83 42; Lucile.GRANGE@chu-st-etienne.fr

Clara PFENNINGER, PhD

CONTACT

(0)477120287; clara.pfenninger@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

FR (1)