[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100408112":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":49,"centralContacts":48,"locations":53,"responsibleParty":154,"collaborators":156,"id":159,"slug":160,"hasResults":161,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":167,"sex":168,"minAge":169,"maxAge":48,"enrollmentInfo":170,"targetDuration":48,"studyType":173,"phases":174,"briefSummary":176,"conditions":177,"keywords":48,"overallStatus":179,"whyStopped":48,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"fullName":5,"class":6},"Merz North America, Inc.","INDUSTRY",[8,14,20,24,28,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Main Period: Placebo (Group P)","PLACEBO_COMPARATOR","Subjects will receive placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Main Period: NT 201 (Group U)","EXPERIMENTAL","Subjects will receive a total of 64 Units (U) of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period.",[19],"Drug: NT 201",{"label":21,"type":16,"description":22,"interventionNames":23},"Main Period: NT 201 and Placebo (Group G and H)","Subjects will receive a total of 40 U of NT 201: 20 U of NT 201 injection both in the GFL and HFL area, and placebo injection in the LCL area on Day 1 of main period.",[19,13],{"label":25,"type":16,"description":26,"interventionNames":27},"OLEX: NT 201 (Main Period: Group P)","Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.",[19],{"label":29,"type":16,"description":26,"interventionNames":30},"OLEX: NT 201 (Main Period: Group U)",[19],{"label":32,"type":16,"description":26,"interventionNames":33},"OLEX: NT 201 (Main Period: Group G and H)",[19],[35,44],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","NT 201","Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% NaCl.",[15,21,32,25,29],[41,42,43],"IncobotulinumtoxinA","Xeomin","Botulinum toxin type A (150 kiloDalton), free from complexing protein",{"type":36,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Placebo","Solution for injection prepared by reconstitution of powder with percent (%) Sodium Chloride (NaCl).",[21,9],null,[50],{"name":51,"affiliation":5,"role":52},"Merz Medical Expert","STUDY_DIRECTOR",[54,67,75,83,92,101,110,118,127,135,140,145],{"facility":55,"status":48,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":48},"Merz Investigational Site","Encino","California","91436","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-118.50119,34.15917,{"lat":65,"lon":64},{"facility":55,"status":48,"city":68,"state":57,"zip":69,"country":59,"countryCode":60,"cosmosGeoPoint":70,"geoPoint":74,"contacts":48},"Newport Beach","92663",{"type":62,"coordinates":71},[72,73],-117.92895,33.61891,{"lat":73,"lon":72},{"facility":55,"status":48,"city":76,"state":57,"zip":77,"country":59,"countryCode":60,"cosmosGeoPoint":78,"geoPoint":82,"contacts":48},"San Diego","92121",{"type":62,"coordinates":79},[80,81],-117.16472,32.71571,{"lat":81,"lon":80},{"facility":55,"status":48,"city":84,"state":85,"zip":86,"country":59,"countryCode":60,"cosmosGeoPoint":87,"geoPoint":91,"contacts":48},"Greenwood Village","Colorado","80111",{"type":62,"coordinates":88},[89,90],-104.95081,39.61721,{"lat":90,"lon":89},{"facility":55,"status":48,"city":93,"state":94,"zip":95,"country":59,"countryCode":60,"cosmosGeoPoint":96,"geoPoint":100,"contacts":48},"Washington D.C.","District of Columbia","20037",{"type":62,"coordinates":97},[98,99],-77.03637,38.89511,{"lat":99,"lon":98},{"facility":55,"status":48,"city":102,"state":103,"zip":104,"country":59,"countryCode":60,"cosmosGeoPoint":105,"geoPoint":109,"contacts":48},"Aventura","Florida","33180",{"type":62,"coordinates":106},[107,108],-80.13921,25.95648,{"lat":108,"lon":107},{"facility":55,"status":48,"city":111,"state":103,"zip":112,"country":59,"countryCode":60,"cosmosGeoPoint":113,"geoPoint":117,"contacts":48},"Boca Raton","33431",{"type":62,"coordinates":114},[115,116],-80.0831,26.35869,{"lat":116,"lon":115},{"facility":55,"status":48,"city":119,"state":120,"zip":121,"country":59,"countryCode":60,"cosmosGeoPoint":122,"geoPoint":126,"contacts":48},"Metairie","Louisiana","70006",{"type":62,"coordinates":123},[124,125],-90.15285,29.98409,{"lat":125,"lon":124},{"facility":55,"status":48,"city":128,"state":128,"zip":129,"country":59,"countryCode":60,"cosmosGeoPoint":130,"geoPoint":134,"contacts":48},"New York","10028",{"type":62,"coordinates":131},[132,133],-74.00597,40.71427,{"lat":133,"lon":132},{"facility":55,"status":48,"city":128,"state":128,"zip":136,"country":59,"countryCode":60,"cosmosGeoPoint":137,"geoPoint":139,"contacts":48},"10065",{"type":62,"coordinates":138},[132,133],{"lat":133,"lon":132},{"facility":55,"status":48,"city":128,"state":128,"zip":141,"country":59,"countryCode":60,"cosmosGeoPoint":142,"geoPoint":144,"contacts":48},"10075",{"type":62,"coordinates":143},[132,133],{"lat":133,"lon":132},{"facility":55,"status":48,"city":146,"state":147,"zip":148,"country":59,"countryCode":60,"cosmosGeoPoint":149,"geoPoint":153,"contacts":48},"Nashville","Tennessee","37215",{"type":62,"coordinates":150},[151,152],-86.78444,36.16589,{"lat":152,"lon":151},{"type":155,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR",[157],{"name":158,"class":6},"Merz Pharmaceuticals GmbH","100408112","phase-3-safety-and-efficacy-study-of-the-simultaneous-treatment-of-upper-facial-lines-horizontal-forehead-lines-glabellar-frown-lines-and-lateral-canthal-lines-in-subjects-with-moderate-to-severe-upper-facial-lines-100408112",true,"NCT04594213","Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Lateral Canthal Lines) in Subjects With Moderate to Severe Upper Facial Lines","A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)","ULTRA I","Inclusion Criteria:\n\n* Outpatients (male or female) 18 years of age or older.\n* Horizontal forehead lines (HFL), glabellar frown lines (GFL), and symmetrical lateral canthal lines (LCL) of moderate to severe intensity at maximum contraction as assessed by the investigator and subject according to Merz Aesthetics Scales (MAS).\n\nExclusion Criteria:\n\n* Previous treatment with botulinum neurotoxin (BoNT) of any serotype in the face within the last 12 months before injection.\n* Any facial cosmetic procedure within the last 12 months before baseline injection.\n* Previous treatment with any biodegradable filler in the face within the last 12 months before injection.\n* Any previous insertion of permanent material in the face (regardless of the time between previous treatment and this study).\n* Any medical condition that may put the subject at increased risk with exposure to NT201.",false,"ALL","18 Years",{"count":171,"type":172},362,"ACTUAL","INTERVENTIONAL",[175],"PHASE3","The purpose of this study is to investigate the safety and efficacy of NT 201 (active ingredient: Botulinum (neuro)toxin type A, free from complexing proteins) in the combined treatment of wrinkles in the upper face (Upper Facial Lines \\[UFL\\]): Horizontal Forehead Lines \\[HFL\\], Glabellar Frown Lines \\[GFL\\], and Lateral Canthal Lines \\[LCL\\]). It is a prospective, randomized, double-blind, placebo-controlled, multicenter study with a placebo-control main period (MP) followed by an open-label extension (OLEX) period.",[178],"Moderate to Severe Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)","COMPLETED","2024-04-11",{"date":182,"type":172},"2024-05-08",{"date":184,"type":172},"2020-09-23",{"date":186,"type":172},"2022-05-09",{"name":5,"class":6},12]