[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658621":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":31,"studyPopulation":31,"armGroups":38,"interventions":45,"overallOfficials":31,"centralContacts":31,"locations":50,"responsibleParty":104,"collaborators":31,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":31,"enrollmentInfo":116,"targetDuration":31,"studyType":119,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":126,"whyStopped":31,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"CGBio Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of Subjects With ≥1-Point Improvement in WSRS","Proportion of subjects with ≥1-point improvement from baseline (Week 0) in the Wrinkle Severity Rating Scale (WSRS) for nasolabial folds. The WSRS ranges from Grade 1 (Absent) to Grade 5 (Extreme), with lower scores indicating less severe nasolabial folds.","Week 12 (Week 16 for subjects receiving touch-up treatment)",[14,16,20,24,28],{"measure":10,"description":11,"timeFrame":15},"Week 24 and Week 52 (Week 28 and Week 56, respectively, for subjects receiving touch-up treatment)",{"measure":17,"description":18,"timeFrame":19},"Independent Evaluator- and Investigator-Assessed GAIS Response Rate","Global Aesthetic Improvement Scale (GAIS) response rate as assessed by independent evaluators and investigators. A responder is defined as a subject with a GAIS score of +1 (Improved), +2 (Much improved), or +3 (Very much improved), using the pre-treatment baseline photograph as the reference.","Week 12, Week 24, and Week 52",{"measure":21,"description":22,"timeFrame":23},"Subject-Assessed GAIS Response Rate","Global Aesthetic Improvement Scale (GAIS) response rate as assessed by subjects. A responder is defined as a subject with a GAIS score of +1 (Improved), +2 (Much improved), or +3 (Very much improved), with baseline appearance used as the reference.","Week 12, Week 24, and Week 52 (Week 16, Week 28, and Week 56, respectively, for subjects receiving touch-up treatment)",{"measure":25,"description":26,"timeFrame":27},"Incidence and Characteristics of Adverse Events and Serious Adverse Events","Incidence, severity, seriousness, causality, and outcome of adverse events (AEs) and serious adverse events (SAEs) occurring throughout the study period.","Throughout the study period, up to Week 52 (Week 56 for subjects receiving touch-up treatment)",{"measure":29,"description":30,"timeFrame":27},"Safety Outcomes According to Fitzpatrick Skin Type","Descriptive evaluation of safety outcomes according to Fitzpatrick skin type, including a prospectively defined safety subgroup of subjects with Fitzpatrick skin types IV-VI.",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"NA","SINGLE_GROUP","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":31},"NONE",[39],{"label":40,"type":41,"description":42,"interventionNames":43},"Facetem S","EXPERIMENTAL","Participants will receive Facetem S injection in the nasolabial folds at baseline. An optional touch-up treatment may be performed approximately 4 weeks after the initial treatment if deemed clinically necessary by the investigator.",[44],"Device: Facetem S",[46],{"type":47,"name":40,"description":48,"armGroupLabels":49,"otherNames":31},"DEVICE","Facetem S is a calcium hydroxylapatite (CaHA) dermal filler administered for the correction of moderate-to-severe nasolabial folds. Treatment will be performed in accordance with the Instructions for Use (IFU). An optional touch-up treatment may be performed approximately 4 weeks after the initial treatment if clinically necessary.",[40],[51,67,79,88,93],{"facility":52,"status":31,"city":53,"state":31,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Medical office","Cannes","06400","France","FR",{"type":58,"coordinates":59},"Point",[60,61],7.01275,43.55135,{"lat":61,"lon":60},[64],{"name":65,"role":66,"phone":31,"phoneExt":31,"email":31},"Isaac Bodokh","CONTACT",{"facility":68,"status":31,"city":69,"state":31,"zip":70,"country":55,"countryCode":56,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"MEDITI Center","Nice","060000",{"type":58,"coordinates":72},[73,74],7.26608,43.70313,{"lat":74,"lon":73},[77],{"name":78,"role":66,"phone":31,"phoneExt":31,"email":31},"Philippe Kestemont",{"facility":80,"status":31,"city":81,"state":31,"zip":82,"country":55,"countryCode":56,"cosmosGeoPoint":83,"geoPoint":87,"contacts":31},"Aesthe.com","Paris","75004",{"type":58,"coordinates":84},[85,86],2.3488,48.85341,{"lat":86,"lon":85},{"facility":52,"status":31,"city":81,"state":31,"zip":89,"country":55,"countryCode":56,"cosmosGeoPoint":90,"geoPoint":92,"contacts":31},"75006",{"type":58,"coordinates":91},[85,86],{"lat":86,"lon":85},{"facility":94,"status":31,"city":95,"state":31,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":31},"Clínicas Uzuri","Madrid","28006","Spain","ES",{"type":58,"coordinates":100},[101,102],-3.70256,40.4165,{"lat":102,"lon":101},{"type":105,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100658621","dermal-evaluation-of-facetem-s-in-nasolabial-folds-esthetics-improvement-define-study-100658621",false,"NCT07855224","Dermal Evaluation of Facetem™ S in Nasolabial Folds Esthetics Improvement: DEFINE Study","A Multicenter, Prospective, Non-randomized, Uncontrolled, Post-market Clinical Follow-up (PMCF) Study to Evaluate the Performance and Safety of Facetem™ S Dermal Fillers for the Correction of Nasolabial Folds","DEFINE","Inclusion Criteria:\n\n1. Male or female, over the age of 18.\n2. Subjects with moderate-to-severe nasolabial folds (WSRS Grade 3-4) on both sides of the face.\n3. Signed informed consent.\n4. Women of childbearing potential must be using a highly effective method of contraception throughout the study period.\n5. Agrees not to undergo any other facial aesthetic procedure that may interfere with the evaluation of nasolabial folds during study participation.\n6. Is willing and able to attend all scheduled follow-up visits and comply with all study requirements.\n\nExclusion Criteria:\n\n1. Any history of treatment with permanent or non-absorbable facial fillers, including silicone, polymethyl methacrylate (PMMA), polytetrafluoroethylene (PTFE), hydroxyethyl methacrylate (HEMA), dextran-based fillers, or other non-resorbable filler materials. Prior treatment with biostimulatory fillers, including poly-L-lactic acid (PLLA), poly-D,L-lactic acid (PDLLA), or other polylactic acid-based fillers, within the past 24 months is also exclusionary. The presence of any foreign particulate material at the treatment site, including liquid silicone or residual filler material, is exclusionary.\n2. Prior botulinum toxin treatment in the treatment area within the past 12 months.\n3. Any prior facial surgical procedures, including plastic surgery or thread lift, or the presence of a permanent surgical implant that could interfere with performance assessments.\n4. Prior treatment within the past 12 months with any dermal filler (e.g., hyaluronic acid, CaHA, collagen-based fillers) in the area to be treated.\n5. Prior treatment within the past 6 months with facial dermal therapies, including but not limited to ablative or non-ablative laser therapy, radiofrequency treatment, chemical or mechanical peels, non-invasive skin-tightening procedures, or planned treatments of this nature during the study period.\n6. History of severe allergic reactions, including anaphylaxis, or known hypersensitivity to any components of the study treatment.\n7. Known bleeding disorder or anticoagulant, antiplatelet, or thrombolytic therapy within 2 weeks prior to treatment that may increase the risk of bleeding, bruising, or other injection-related complications.\n8. Active inflammation, infection, or skin conditions at or near the injection site.\n9. History of keloid or hypertrophic scar formation, or any condition that predisposes the subject to abnormal wound healing, subjects prone to inflammatory skin diseases, or presence of foreign materials at the treatment site.\n10. Pregnant or nursing women, or those planning to become pregnant during the study.\n11. Autoimmune diseases, immunodeficiency disorders, or ongoing immunosuppressive therapy.\n12. Use of immunosuppressive agents or other systemic medications within the past 3 months.\n13. Active infectious disease, including viral hepatitis or syphilis.\n14. Current chronic systemic corticosteroid therapy, defined as continuous systemic corticosteroid use for ≥4 weeks at a dose equivalent to ≥10 mg\u002Fday of prednisone.\n15. Participation in another drug or medical device clinical trial within the past 3 months.\n16. Any other condition that, in the investigator's judgment, makes the subject unsuitable for study participation.\n17. Subjects who are incarcerated or under legal guardianship and are unable to understand the study or provide informed consent.\n18. Subjects with clinically significant severe facial asymmetry, scars, deformities, or other conditions involving the nasolabial fold area that, in the opinion of the investigator, may compromise standardized photographic documentation or reliable assessment of WSRS and GAIS outcomes.","ALL","18 Years",{"count":117,"type":118},100,"ESTIMATED","INTERVENTIONAL",[33],"This is a multicenter, prospective, non-randomized, uncontrolled post-market clinical follow-up (PMCF) study designed to evaluate the performance and safety of Facetem S dermal filler for the correction of moderate-to-severe nasolabial folds in adult subjects.\n\nSubjects will receive Facetem S treatment at baseline, with an optional touch-up treatment approximately 4 weeks later if clinically necessary. Subjects will be followed for up to 12 months after the final injection to assess wrinkle severity improvement, overall aesthetic improvement, and safety.",[123],"Nasolabial Folds",[125],"Dermal Filler","NOT_YET_RECRUITING","2026-09-28",{"date":129,"type":130},"2026-10-02","ACTUAL",{"date":132,"type":118},"2027-01",{"date":134,"type":118},"2029-01",{"name":5,"class":6},5]