[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100193284":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":29,"responsibleParty":71,"collaborators":25,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":25,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":25,"overallStatus":92,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Hugel","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Botulinum toxin type A(Botox®)","ACTIVE_COMPARATOR","Botulinum toxin type A",[13],"Drug: Botulinum toxin type A(Botulax®)",{"label":15,"type":16,"description":11,"interventionNames":17},"Botulinum toxin type A (Botulax®)","EXPERIMENTAL",[18],"Drug: Botulinum toxin type A(Botox®)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Botulinum toxin type A(Botulax®)","Single administration, Day 0, 20 units",[9],null,{"type":21,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"Single administration, Day 0, 20units",[15],[30,41,47,53,59,65],{"facility":31,"status":25,"city":32,"state":33,"zip":25,"country":34,"countryCode":25,"cosmosGeoPoint":35,"geoPoint":40,"contacts":25},"Chung-Ang University Hopspital","Seoul","Dongjak-gu","South Korea",{"type":36,"coordinates":37},"Point",[38,39],126.9784,37.566,{"lat":39,"lon":38},{"facility":42,"status":25,"city":32,"state":43,"zip":25,"country":34,"countryCode":25,"cosmosGeoPoint":44,"geoPoint":46,"contacts":25},"Seoul National University Hospital","Jongno-Gu",{"type":36,"coordinates":45},[38,39],{"lat":39,"lon":38},{"facility":48,"status":25,"city":32,"state":49,"zip":25,"country":34,"countryCode":25,"cosmosGeoPoint":50,"geoPoint":52,"contacts":25},"National Medical Center","Jung-Gu",{"type":36,"coordinates":51},[38,39],{"lat":39,"lon":38},{"facility":54,"status":25,"city":32,"state":55,"zip":25,"country":34,"countryCode":25,"cosmosGeoPoint":56,"geoPoint":58,"contacts":25},"Eulji General Hospital","Nowon-Gu",{"type":36,"coordinates":57},[38,39],{"lat":39,"lon":38},{"facility":60,"status":25,"city":32,"state":61,"zip":25,"country":34,"countryCode":25,"cosmosGeoPoint":62,"geoPoint":64,"contacts":25},"The catholic university of Korea, Seoul ST. Mary's Hospital","Seocho-Gu",{"type":36,"coordinates":63},[38,39],{"lat":39,"lon":38},{"facility":66,"status":25,"city":32,"state":67,"zip":25,"country":34,"countryCode":25,"cosmosGeoPoint":68,"geoPoint":70,"contacts":25},"Korea University Anam Hospital","Seongbuk-Gu",{"type":36,"coordinates":69},[38,39],{"lat":39,"lon":38},{"type":72,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100193284","phase-3-to-evaluate-the-safety-and-efficacy-of-botulax-are-not-inferior-to-those-of-botox-in-the-treatment-of-glabellar-lines-100193284",false,"NCT01791920","To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines","Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of \"Botulax®\" Compared to Botox Inj. in Patients With Moderate to Severe Glabellar Lines","Inclusion Criteria:\n\n* Men and women aged between 18 and 65\n* Patients attaining grade 2 or 3 in the investigator's rating of glabellar lines severity at maximum frown\n* Patients who voluntarily sign the informed consent\n* Patients who can comply with the study procedures and visit schedule\n\nExclusion Criteria:\n\n* Subjects who had facial plastic surgery (tissue augmentation, brow lift, and dermal resurfacing)treatment within 6 months. Those who had peeling or laser therapy\n* Subjects with skin disorders, scar or infection around glabellar region\n* Subjects who are taking Aspirin, NSAIDS or anti-coagulant\n* Subjects with facial palsy or eyelid ptosis\n* Subjects who diagnosed as neuromuscular junction disorder (e.g., myasthenia gravis, Lambert-Eaton Syndrome)\n* Subjects with history of drug intoxication, alcohol abuse and\u002For depressive disorder\n* Subjects with severe internal diseases (cardiovascular, respiratory, renal disease, liver disorder)\n* Subjects who have previously been treated with botulinum toxin within 3 months (Botulinum toxin type A: 3months, type B: 4 months)\n* Subject who have administered following drugs within the previous 4 months: Spectinomycin Hydrochloride, Aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, muscle relaxants, anti-cholinergic agents, benzodiazepine and similar drugs, benzamide drugs, Tubocurarine-type muscle relaxants\n* Subjects who have possibility to take the drugs listed above\n* Subjects who have a plan to receive facial cosmetic procedures including dermal filler, chemical peeling and dermabrasion during study period\n* Subjects who have glabellar lines that are unable to be improved with any physical method\n* Subjects who have history of hypersensitivity to Botulinum toxin and other agents\n* Subjects who are pregnant or breast-feeding\n* Subjects who have a plan to be pregnant in 3months, or who are not doing contraceptive\n* Subjects who participated in other studies within 30 days or were not passed over 5 times of half life for investigational product\n* Subjects who are having trouble with acute disease\n* Subjects who have taken any treatment that can affect to glabellar lines and\u002For any lines around forehead within the previous 6 months\n* Subjects who are unable to communicate or follow the instructions\n* Subjects who are not eligible for this study based on investigator's judgement","ALL","18 Years","65 Years",{"count":84,"type":85},262,"ACTUAL","INTERVENTIONAL",[88],"PHASE3","To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.",[91],"Skin Aging","COMPLETED","2022-04-14",{"date":95,"type":85},"2022-04-15",{"date":97,"type":25},"2011-08",{"date":99,"type":85},"2012-03",{"name":5,"class":6},6]