CHU de Saint-Etienne
Saint-Priest-en-Jarez, Pays de la Loire Region, 42270, France
Location status: Recruiting
NCT Number: NCT07543679
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Saint-Priest-en-Jarez, Pays de la Loire Region, 42270, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluation of stiffness, elastic modulus and pile-up height for ScS patients and controls by ADHELASKIN device
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
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
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)
Time frame: Day 1
Comparison of overall and local averages and sums of firmness values measured by the ADHELASKIN device in micrometers (μm)
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
Time frame: Day 1
Standardized patient experience questionnaire in ScS and healthy patients.
Time frame: Day 1
Measurement of stiffness in N/m on a small cohort of 10 patients by 2 investigators 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
Contact information is provided by the study sponsor or research team.
Clara PFENNINGER, PhD
CONTACT
(0)477120287 ext. +33
Lucile GRANGE, MD
CONTACT
(0)4 77 82 83 42 ext. +33
Centre Hospitalier Universitaire de Saint Etienne
Other
Acronym: OBSKINS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06947460
Autoimmune Diseases, Connective Tissue Diseases
Beijing, China,Beijing, China
View Trial DetailsNCT07295847
Arthritis, Arthritis, Rheumatoid
Tucson, Arizona, United States
View Trial DetailsNCT07085104
Autoimmune Diseases, Connective Tissue Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT07090226
Connective Tissue Diseases, Diffuse Cutaneous Scleroderma
Boston, Massachusetts, United States
View Trial Details