[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572521":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":39,"interventions":57,"overallOfficials":68,"centralContacts":72,"locations":78,"responsibleParty":230,"collaborators":27,"id":232,"slug":27,"hasResults":233,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":27,"eligibilityCriteria":237,"healthyVolunteers":233,"sex":238,"minAge":239,"maxAge":27,"enrollmentInfo":240,"targetDuration":27,"studyType":243,"phases":244,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":81,"whyStopped":27,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},{"fullName":5,"class":6},"AbbVie","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":27},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants Achieving \"Responder\" Status Based on the Evaluating Investigator's (EI) Live Assessment of Mid-Face Volume Deficit Scale (MFVDS)","A \"responder\" is defined as a participant with at least 1-point improvement (reduction) of mid face volume deficit using the MFVDS. MFVDS is a validated 5-point scale (1 = None\u002FMinimal to 5 = Severe).","Month 6",{"measure":14,"description":15,"timeFrame":16},"Number of Participants with Adverse Events (AEs)","An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.","Up to Approximately Month 31",[18,21,24],{"measure":19,"description":20,"timeFrame":12},"Change from Baseline in the Overall Score of FACE-Q Satisfaction with Cheeks","The FACE-Q Satisfaction with Cheeks questionnaire is a 5-point survey where 1 = Very Dissatisfied and 4 = Very Satisfied.",{"measure":22,"description":23,"timeFrame":12},"Percentage of Participants Achieving \"Responder\" Status Based on Participant's Assessments of Global Aesthetic Improvement in the Treatment Area Using Global Aesthetic Improvement Scale (GAIS)","A \"responder\" is defined as a participant who achieves \"Improved\" or \"Much Improved\" on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the treatment area (2 = Much Improved to -2 = Much Worse).",{"measure":25,"description":26,"timeFrame":12},"Percentage of Participants Achieving \"Responder\" Status Based on EI's Assessments of Global Aesthetic Improvement in the Treatment Area Using the GAIS","A \"responder\" is defined as a participant who achieves \"Improved\" or \"Much Improved\" on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the treatment area (2 = Much Improved, -2 = Much Worse).",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":34},"QUADRUPLE",[35,36,37,38],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[40,46,51,54],{"label":41,"type":42,"description":43,"interventionNames":44},"Cohort 1: NOA VOLUME","EXPERIMENTAL","Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18.",[45],"Device: NOA VOLUME",{"label":47,"type":42,"description":48,"interventionNames":49},"Cohort 1: VOLUMA XC","Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18.",[50],"Device: VOLUMA XC",{"label":52,"type":42,"description":43,"interventionNames":53},"Cohort 2: NOA VOLUME",[45],{"label":55,"type":42,"description":48,"interventionNames":56},"Cohort 2: VOLUMA XC",[50],[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":27},"DEVICE","NOA VOLUME","Injections",[41,52],{"type":59,"name":64,"description":61,"armGroupLabels":65,"otherNames":66},"VOLUMA XC",[47,55],[67],"JUVÉDERM",[69],{"name":70,"affiliation":5,"role":71},"ABBVIE INC.","STUDY_DIRECTOR",[73],{"name":74,"role":75,"phone":76,"phoneExt":27,"email":77},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[79,93,103,113,123,132,138,152,162,172,182,190,200,210,220],{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":27},"Total Skin and Beauty Dermatology Center \u002FID# 258164","RECRUITING","Birmingham","Alabama","35205","United States","US",{"type":88,"coordinates":89},"Point",[90,91],-86.80249,33.52066,{"lat":91,"lon":90},{"facility":94,"status":81,"city":95,"state":96,"zip":97,"country":85,"countryCode":86,"cosmosGeoPoint":98,"geoPoint":102,"contacts":27},"Advanced Research Associates - Glendale \u002FID# 276812","Glendale","Arizona","85308",{"type":88,"coordinates":99},[100,101],-112.18599,33.53865,{"lat":101,"lon":100},{"facility":104,"status":81,"city":105,"state":106,"zip":107,"country":85,"countryCode":86,"cosmosGeoPoint":108,"geoPoint":112,"contacts":27},"West Dermatology La Jolla \u002FID# 278590","San Diego","California","92121",{"type":88,"coordinates":109},[110,111],-117.16472,32.71571,{"lat":111,"lon":110},{"facility":114,"status":81,"city":115,"state":116,"zip":117,"country":85,"countryCode":86,"cosmosGeoPoint":118,"geoPoint":122,"contacts":27},"Susan H. Weinkle MD \u002FID# 258160","Bradenton","Florida","34209-5642",{"type":88,"coordinates":119},[120,121],-82.57482,27.49893,{"lat":121,"lon":120},{"facility":124,"status":81,"city":125,"state":116,"zip":126,"country":85,"countryCode":86,"cosmosGeoPoint":127,"geoPoint":131,"contacts":27},"Hevia Cosmetic Dermatology \u002FID# 258165","Coral Gables","33134",{"type":88,"coordinates":128},[129,130],-80.26838,25.72149,{"lat":130,"lon":129},{"facility":133,"status":81,"city":125,"state":116,"zip":134,"country":85,"countryCode":86,"cosmosGeoPoint":135,"geoPoint":137,"contacts":27},"Skin Research Institute LLC \u002FID# 258158","33146-1837",{"type":88,"coordinates":136},[129,130],{"lat":130,"lon":129},{"facility":139,"status":81,"city":140,"state":141,"zip":142,"country":85,"countryCode":86,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Atlanta Biomedical Clinical Research \u002FID# 261210","Atlanta","Georgia","30331-2160",{"type":88,"coordinates":144},[145,146],-84.38798,33.749,{"lat":146,"lon":145},[149],{"name":150,"role":75,"phone":151,"phoneExt":27,"email":27},"Site Coordinator","678-515-3446",{"facility":153,"status":81,"city":154,"state":155,"zip":156,"country":85,"countryCode":86,"cosmosGeoPoint":157,"geoPoint":161,"contacts":27},"Pure Dermatology \u002FID# 258168","Metairie","Louisiana","70001",{"type":88,"coordinates":158},[159,160],-90.15285,29.98409,{"lat":160,"lon":159},{"facility":163,"status":81,"city":164,"state":165,"zip":166,"country":85,"countryCode":86,"cosmosGeoPoint":167,"geoPoint":171,"contacts":27},"Aesthetic Center at Woodholme \u002FID# 258166","Baltimore","Maryland","21208-6391",{"type":88,"coordinates":168},[169,170],-76.61219,39.29038,{"lat":170,"lon":169},{"facility":173,"status":81,"city":174,"state":175,"zip":176,"country":85,"countryCode":86,"cosmosGeoPoint":177,"geoPoint":181,"contacts":27},"Edwin F. Williams III, MD FACS of LATHAM P.C. D\u002FB\u002FA THE REJUVA CENTER \u002FID# 261211","Latham","New York","12110",{"type":88,"coordinates":178},[179,180],-73.75901,42.74702,{"lat":180,"lon":179},{"facility":183,"status":81,"city":175,"state":175,"zip":184,"country":85,"countryCode":86,"cosmosGeoPoint":185,"geoPoint":189,"contacts":27},"Jane Yoo MD \u002FID# 279811","10019",{"type":88,"coordinates":186},[187,188],-74.00597,40.71427,{"lat":188,"lon":187},{"facility":191,"status":81,"city":192,"state":193,"zip":194,"country":85,"countryCode":86,"cosmosGeoPoint":195,"geoPoint":199,"contacts":27},"Northwest Dermatology Institute \u002FID# 258167","Portland","Oregon","97210-2859",{"type":88,"coordinates":196},[197,198],-122.67621,45.52345,{"lat":198,"lon":197},{"facility":201,"status":81,"city":202,"state":203,"zip":204,"country":85,"countryCode":86,"cosmosGeoPoint":205,"geoPoint":209,"contacts":27},"Westlake Dermatology & Cosmetic Surgery - Westlake \u002FID# 258156","Austin","Texas","78746-4720",{"type":88,"coordinates":206},[207,208],-97.74306,30.26715,{"lat":208,"lon":207},{"facility":211,"status":81,"city":212,"state":213,"zip":214,"country":85,"countryCode":86,"cosmosGeoPoint":215,"geoPoint":219,"contacts":27},"SkinDC \u002FID# 258163","Arlington","Virginia","22209",{"type":88,"coordinates":216},[217,218],-77.10428,38.88101,{"lat":218,"lon":217},{"facility":221,"status":81,"city":222,"state":223,"zip":224,"country":85,"countryCode":86,"cosmosGeoPoint":225,"geoPoint":229,"contacts":27},"EthiQ2 Research, LLC \u002FID# 258906","Brookfield","Wisconsin","53005",{"type":88,"coordinates":226},[227,228],-88.10648,43.06057,{"lat":228,"lon":227},{"type":231,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100572521",false,"NCT06734351","A Study to Evaluate Safety and Effectiveness of NOA VOLUME Injectable Gel in Adult Participants Compared to JUVÉDERM VOLUMA XC for Improvement of Mid-Face Volume","A Multicenter, Evaluator and Subject-blinded, Randomized, Comparator-controlled, Parallel-design Study to Evaluate the Safety and Effectiveness of NOA VOLUME Compared to JUVÉDERM® VOLUMA® XC for Improvement of Mid-face Volume","Inclusion Criteria:\n\n* Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the 5-point photonumeric MFVDS based on evaluating investigator's (EI) live assessment.\n* Mid-face is amenable to achieving at least a 1-point improvement in MFVDS score with the allowed injection volume in the treating investigator's (TI) judgement.\n\nExclusion Criteria:\n\n* Significant skin laxity in the midface in the opinion of the TI.\n* Significant skin pigmentation disorders or discoloration in the mid-face area that would interfere with the visual assessment of the mid-face area.\n* Current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, unhealed wound, or cancerous or precancerous lesion on the face.","ALL","22 Years",{"count":241,"type":242},231,"ESTIMATED","INTERVENTIONAL",[245],"PHASE3","Facial fullness is often regarded as a characteristic feature of a youthful face. Chronic reduction of collagen, elastin, and glycosaminoglycans contribute to the facial volume loss that characterizes the aging face. Volume restoration by replacing or augmenting soft tissue is critical to successful facial rejuvenation. NOA VOLUME is a crosslinked Hyaluronic Acid (HA) injectable gel formulated with lidocaine that was developed to provide a safe, minimally invasive method of improving mid-face volume deficit. The purpose of this study is to assess safety and effectiveness of NOA VOLUME in adult participants seeking improvement of mid-face volume compared to JUVÉDERM VOLUMA XC (VOLUMA XC).\n\nNOA VOLUME is an investigational device being developed for the improvement of mid-face volume. There will be 2 cohorts in this study. Participants will receive either NOA VOLUME or VOLUMA XC. Around 231 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 15 sites in the United States.\n\nParticipants will receive either NOA VOLUME or VOLUMA XC injections in the cheek area on Day 1. Participants will receive optional touch-up treatment at Day 31 and optional repeat treatment at Month 18 and will be followed up for up to 31 months.",[248],"Mid Face Volume Deficit",[248,60,250],"JUVÉDERM® VOLUMA® XC","2026-06-16",{"date":253,"type":254},"2026-06-18","ACTUAL",{"date":256,"type":254},"2024-12-16",{"date":258,"type":242},"2029-07",{"name":5,"class":6},15]