NCT07543679Recruiting
Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 7 May 2026
- Primary completion date
- 1 May 2027
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT07543679
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 7 May 2026 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.