[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634745":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":51,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":24,"enrollmentInfo":62,"targetDuration":24,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ScS patients","EXPERIMENTAL","Patients with SSc according to the 2013 ACR\u002FEULAR criteria",[13],"Device: ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)",{"label":15,"type":10,"description":16,"interventionNames":17},"Control group","Patients without significant skin involvement",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)","Evaluation of stiffness, elastic modulus and pile-up height for ScS patients and controls by ADHELASKIN device",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Lucile GRANGE, MD","Centre hospitalo-universitaire de Saint-Etienne","PRINCIPAL_INVESTIGATOR",[31,36],{"name":27,"role":32,"phone":33,"phoneExt":34,"email":35},"CONTACT","(0)4 77 82 83 42","+33","Lucile.GRANGE@chu-st-etienne.fr",{"name":37,"role":32,"phone":38,"phoneExt":34,"email":39},"Clara PFENNINGER, PhD","(0)477120287","clara.pfenninger@chu-st-etienne.fr",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":24,"geoPoint":24,"contacts":49},"CHU de Saint-Etienne","RECRUITING","Saint-Priest-en-Jarez","Pays de la Loire Region","42270","France","FR",[50],{"name":27,"role":32,"phone":33,"phoneExt":34,"email":35},{"type":52,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100634745","objective-assessment-of-skin-damage-using-adhelaskin-in-patients-with-systemic-sclerosis-100634745",false,"NCT07543679","Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis","OBSKINS","Inclusion Criteria:\n\n* Patients affiliated with or eligible for social security\n* Patients who have received informed consent about the study and have co-signed, with the investigator, a consent form to participate in the study\n* For case patients: Patients with SSc according to the 2013 ACR\u002FEULAR criteria\n* For control patients: Patients without significant skin involvement\n\nExclusion Criteria:\n\n* Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than research;\n* Adults subject to legal protection measures (guardianship-curatorship) or unable to express their consent\n* Inflammatory or scarring dermatoses in different individuals","ALL","18 Years",{"count":63,"type":64},100,"ESTIMATED","INTERVENTIONAL",[67],"NA","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.\n\nHowever, 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.\n\nADHELASKIN° technology (by Tactinnov, LTDS \u002F 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.",[70],"D013493",[72,73,74,75,76],"Systemic sclerosis","firmness","skin evaluation","Rodnan score","mRSS","2026-05-07",{"date":79,"type":80},"2026-05-12","ACTUAL",{"date":77,"type":80},{"date":83,"type":64},"2027-05-01",{"name":5,"class":6},1]