[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588173":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":30,"interventions":49,"overallOfficials":18,"centralContacts":59,"locations":68,"responsibleParty":187,"collaborators":18,"id":189,"slug":18,"hasResults":190,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":18,"eligibilityCriteria":194,"healthyVolunteers":190,"sex":195,"minAge":196,"maxAge":197,"enrollmentInfo":198,"targetDuration":18,"studyType":201,"phases":202,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":71,"whyStopped":18,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},{"fullName":5,"class":6},"JHM BioPharma (Tonghua) Co. , Ltd.","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Outcome Measure","Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 4 visit relative to baseline, based on both the investigators´ and the subjects´ in-clinic assessments.","Within 4 weeks",[14],{"measure":15,"description":16,"timeFrame":17},"Secondary Outcome Measure","Incidence of serious adverse events and drug-related adverse events during the study.","Within 52 weeks",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","Biological: Rcombinant botulinum toxin type A for injection (Eveotox) Biological: OnabotulinumtoxinA (Botox) Biological: : Placebo","TREATMENT",{"masking":25,"maskingDescription":18,"whoMasked":26},"TRIPLE",[27,28,29],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[31,37,43],{"label":32,"type":33,"description":34,"interventionNames":35},"Eveotox","EXPERIMENTAL","Eveotox, 20 Units, divided into five injections into the glabellar area. Administered in double-blind fashion at cycle 1 followed by up to 3 open-label cycles.",[36],"Biological: Rcombinant botulinum toxin type A for injection（Eveotox)",{"label":38,"type":39,"description":40,"interventionNames":41},"OnabotulinumtoxinA (Botox )","ACTIVE_COMPARATOR","Botox,20 Units, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units).",[42],"Biological: OnabotulinumtoxinA (Botox)",{"label":44,"type":45,"description":46,"interventionNames":47},"Placebo","PLACEBO_COMPARATOR","Placebo, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units)",[48],"Biological: Placebo",[50,54,57],{"type":51,"name":52,"description":52,"armGroupLabels":53,"otherNames":18},"BIOLOGICAL","Rcombinant botulinum toxin type A for injection（Eveotox)",[32],{"type":51,"name":55,"description":55,"armGroupLabels":56,"otherNames":18},"OnabotulinumtoxinA (Botox)",[38],{"type":51,"name":44,"description":44,"armGroupLabels":58,"otherNames":18},[44],[60,65],{"name":61,"role":62,"phone":63,"phoneExt":18,"email":64},"Danhua Lin","CONTACT","15811460241","danhua.lin@jhm-biopharma.com",{"name":66,"role":62,"phone":18,"phoneExt":18,"email":67},"Lei Wang","lei.wang@jhm-biopharma.com",[69,82,87,92,101,110,115,124,133,142,151,155,164,173,182],{"facility":70,"status":71,"city":72,"state":73,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":18},"Peking Union Medical College Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":77,"coordinates":78},"Point",[79,80],116.39723,39.9075,{"lat":80,"lon":79},{"facility":83,"status":71,"city":72,"state":73,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":84,"geoPoint":86,"contacts":18},"Peking University First Hospital",{"type":77,"coordinates":85},[79,80],{"lat":80,"lon":79},{"facility":88,"status":71,"city":72,"state":73,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":89,"geoPoint":91,"contacts":18},"Peking University Third Hospital",{"type":77,"coordinates":90},[79,80],{"lat":80,"lon":79},{"facility":93,"status":71,"city":94,"state":95,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":96,"geoPoint":100,"contacts":18},"The First Affiliated Hospital of Chongqing Medical University","Chongqing","Chongqing Municipality",{"type":77,"coordinates":97},[98,99],106.55771,29.56026,{"lat":99,"lon":98},{"facility":102,"status":71,"city":103,"state":104,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":105,"geoPoint":109,"contacts":18},"The First Affiliated Hospital of Jinan University","Guangzhou","Guangdong",{"type":77,"coordinates":106},[107,108],113.25,23.11667,{"lat":108,"lon":107},{"facility":111,"status":71,"city":103,"state":104,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":112,"geoPoint":114,"contacts":18},"The Third Affiliated Hospital of Sun Yat-sen University",{"type":77,"coordinates":113},[107,108],{"lat":108,"lon":107},{"facility":116,"status":71,"city":117,"state":118,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":119,"geoPoint":123,"contacts":18},"The First Hospital of Hebei Medical University","Shijiazhuang","Hebei",{"type":77,"coordinates":120},[121,122],114.47861,38.04139,{"lat":122,"lon":121},{"facility":125,"status":71,"city":126,"state":127,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":128,"geoPoint":132,"contacts":18},"The Third Xiangya Hospital of Central South University","Changsha","Hunan",{"type":77,"coordinates":129},[130,131],112.97087,28.19874,{"lat":131,"lon":130},{"facility":134,"status":71,"city":135,"state":136,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":137,"geoPoint":141,"contacts":18},"The Affiliated Hospital of Xuzhou Medical University","Xuzhou","Jiangsu",{"type":77,"coordinates":138},[139,140],117.28386,34.20442,{"lat":140,"lon":139},{"facility":143,"status":71,"city":144,"state":145,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":146,"geoPoint":150,"contacts":18},"Huashan Hospital, Fudan University","Shanghai","Shanghai Municipality",{"type":77,"coordinates":147},[148,149],121.45806,31.22222,{"lat":149,"lon":148},{"facility":152,"status":71,"city":153,"state":154,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":18,"geoPoint":18,"contacts":18},"Xianyang Hospital of Yan'an University","Xianyang","Shanxi",{"facility":156,"status":71,"city":157,"state":158,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":159,"geoPoint":163,"contacts":18},"West China Hospital, Sichuan University","Chengdu","Sichuan",{"type":77,"coordinates":160},[161,162],104.06667,30.66667,{"lat":162,"lon":161},{"facility":165,"status":71,"city":166,"state":167,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":168,"geoPoint":172,"contacts":18},"Tianjin Medical University General Hospital","Tianjin","Tianjin Municipality",{"type":77,"coordinates":169},[170,171],117.17667,39.14222,{"lat":171,"lon":170},{"facility":174,"status":71,"city":175,"state":176,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":177,"geoPoint":181,"contacts":18},"Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University","Hangzhou","Zhejiang",{"type":77,"coordinates":178},[179,180],120.16142,30.29365,{"lat":180,"lon":179},{"facility":183,"status":71,"city":175,"state":176,"zip":18,"country":74,"countryCode":75,"cosmosGeoPoint":184,"geoPoint":186,"contacts":18},"Zhejiang Provincial People's Hospital",{"type":77,"coordinates":185},[179,180],{"lat":180,"lon":179},{"type":188,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100588173",false,"NCT06937944","Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines","A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection (Eveotox) Compared With a Single Treatment of Botox and Placebo,and Repeated Treatment of Eveotox in Moderate to Severe Glabellar Lines","Inclusion Criteria:\n\n* Male or female subjects who are between 18 to 65 years of age\n* Moderate or severe glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity scale\n* Moderate or severe glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity scale\n* Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial\n\nExclusion Criteria:\n\n* Subjects who have a history of oversensitivity to the Botulinum Toxin A type or other components of the study drug\n* Subjects who have implanted any permanent materials in the glabellar area or received semi-permanent fillers within the first 2 years of screening\n* Subjects with active skin infections at the injection site or systemic skin disease, which the investigator judges can affect the evaluation of efficacy or safety\n* Subjects who have a history of injecting drugs similar to the study drug within 6 months prior to selection or are foreseen to use during the study period","ALL","18 Years","65 Years",{"count":199,"type":200},669,"ESTIMATED","INTERVENTIONAL",[203],"PHASE3","This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single\u002Frepeated injections of Eveotox in the treatment of moderate to severe glabellar lines. The study consists of Study Part 1 (randomized double-blind controlled study) and Part 2 (open-label study). Part I is a multicenter, randomized, double-blind, single-injection, active-controlled and placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of Eveotox in the treatment of moderate to severe glabellar lines; Part 2 is an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of Eveotox in the treatment of moderate to severe glabellar lines.",[206],"Moderate to Severe Glabellar Lines",[206],"2025-08-25",{"date":210,"type":211},"2025-09-02","ACTUAL",{"date":213,"type":211},"2025-04-30",{"date":215,"type":200},"2026-08",{"name":5,"class":6},15]