[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654770":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":16,"studyPopulation":16,"armGroups":27,"interventions":38,"overallOfficials":44,"centralContacts":48,"locations":54,"responsibleParty":68,"collaborators":16,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":16,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":16,"enrollmentInfo":79,"targetDuration":16,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":16,"overallStatus":88,"whyStopped":16,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Galderma R&D","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Responder rate based on the Blind Evaluators' live assessment using the Galderma Jawline Scale(GJS) .","A responder is defined as ≥1 grade improvement on the GJS from baseline on both jawlines concurrently.\n\nGJS is a 5-grade scale ranging from none to severe Jawline definition deficiency.","At 6 months after the last treatment for the Treatment group and at 6 months after baseline for the Control group.",[14],{"measure":15,"description":16,"timeFrame":17},"Responder rate based on the Blinded Evaluators' live assessment using the GJS",null,"At 3, 9 and 12 months after last treatment for Treatment group and at 3 months after baseline, as well as at 3 and 6 months after optional treatment for the Control group.",{"allocation":19,"interventionModel":20,"interventionModelDescription":16,"primaryPurpose":21,"observationalModel":16,"timePerspective":16,"maskingInfo":22},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":23,"maskingDescription":24,"whoMasked":25},"SINGLE","A blind evaluator to assess study primary endpoint.",[26],"OUTCOMES_ASSESSOR",[28,34],{"label":29,"type":30,"description":31,"interventionNames":32},"Treatment Group","EXPERIMENTAL","Restylane Shaype Subjects in the Treatment Group will be treated with Restylane Shaype at Baseline, Week 4(optional touch-up).",[33],"Device: Restylane Shaype",{"label":35,"type":36,"description":37,"interventionNames":16},"Control group","NO_INTERVENTION","No treatment Control Group",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":16},"DEVICE","Restylane Shaype","Restylane Shaype is an injectable, sterile, transparent, biodegradable gel of non-animal crosslinked sodium hyaluronate. Restylane Shaype has the addition of lidocaine hydrochloride. They are supplied in a glass syringe.",[29],[45],{"name":46,"affiliation":46,"role":47},"Galderma S.A.","STUDY_DIRECTOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":16,"email":53},"Galderma Research & Development","CONTACT","+8621 23159790","Clinical.Studies@galderma.com",[55],{"facility":56,"status":16,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":16},"Galderma Investigational Site #6340","Beijing","Beijing Municipality","100000","China","CN",{"type":63,"coordinates":64},"Point",[65,66],116.39723,39.9075,{"lat":66,"lon":65},{"type":69,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100654770","a-study-to-evaluate-the-effectiveness-and-safety-of-restylane-shaype-in-the-improvement-of-jawline-definition-100654770",false,"NCT07805512","A Study to Evaluate the Effectiveness and Safety of Restylane Shaype in the Improvement of Jawline Definition","A Randomized, Evaluator-blinded, Parallel Group, No-treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of Restylane® Shaype™ for Improvement of Jawline Definition in Chinese Subjects","Inclusion Criteria:\n\n1. Males and non-pregnant, non-breastfeeding females of Chinese origin and aged 18 years or older.\n2. Intent to receive bilateral jawline definition treatment.\n\nExclusion Criteria:\n\n1. Known\u002Fprevious allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.\n2. Known\u002Fprevious allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.\n3. Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.\n4. Prior surgery in the treatment area that in the Treatment investigator's opinion could interfere with the study safety and\u002For effectiveness assessments.\n5. Any previous aesthetic procedures or implants.\n6. Presence of any disease or lesions near or in the area to be treated.","ALL","18 Years",{"count":80,"type":81},162,"ESTIMATED","INTERVENTIONAL",[84],"NA","This is a randomized, evaluator-blinded, parallel group, no-treatment controlled, multicenter study to evaluate effectiveness and the safety of Restylane Shaype for improvement of jawline definition in China. Subjects of Chinese origin, age 18 years, who are eligible for treatment to improve jawline definition. Study sites is approximately 6.\n\nA total of approximately 162 subjects will be randomized (2:1) to either treatment with Restylane Shaype Treatment Group (approximately 108subjects) or no-treatment Control Group (approximately 54 subjects).",[87],"Jawline Definition","NOT_YET_RECRUITING","2026-09-10",{"date":91,"type":92},"2026-09-15","ACTUAL",{"date":94,"type":81},"2026-09",{"date":96,"type":81},"2028-03",{"name":5,"class":6},1]