Measuring Skin Hardness With a Device in People With Systemic Sclerosis
Tests a device that measures skin firmness and elasticity in adults with systemic sclerosis.
Plain-language title generated from the registry record
Registry title: Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis
Key facts
- Where
- Saint-Priest-en-Jarez, FranceSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with systemic sclerosis, and also for people without significant skin lesions as a comparison group. It tests a device that measures skin stiffness and elasticity.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Patients with systemic sclerosis according to the 2013 ACR/EULAR criteria. The comparison group has no significant skin lesions.
Main reasons for not taking part
- People deprived of their liberty, or hospitalized without consent
- Adults under legal protection (guardianship) or unable to give consent
- Inflammatory or scarring skin diseases
Read by machine on 12 November 2026.
Where in France
- Chu de Saint EtienneSaint-Priest-en-Jarez, FranceContact: Lucile GRANGE, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Centre Hospitalier Universitaire de Saint Etienne
- Trial code
- NCT07543679
- Record updated
- 31 July 2026
- Original description
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.Read full original descriptionShow less
Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis
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.
Inclusion: 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 healthy patients: Patients without significant skin lesions who are outpatients or inpatients at a department of the Saint-Etienne University Hospital; For healthy volunteers: Volunteers without significant skin lesions who work at the Saint-Etienne University Hospital and whose participation in the study does not require any special travel.
Exclusion: 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.