Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Objectively compare skin stiffness in patients with systemic sclerosis versus healthy patients
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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 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
Arms & Interventions
ScS patients
Patients with SSc according to the 2013 ACR/EULAR criteria
Intervention: ADHELASKIN (Tactinnov° - Ecole centrale de Lyon) (Device)
Control group
Patients without significant skin involvement
Intervention: ADHELASKIN (Tactinnov° - Ecole centrale de Lyon) (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
- Estimate inter-investigator variability in stiffness measurement using ADHELASKIN(Day 1)
- Compare the duration of skin stiffness measurement examinations of 17 body regions by mRSS score and using ADHELASKIN(Day 1)