[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531899":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":36,"interventions":49,"overallOfficials":26,"centralContacts":59,"locations":69,"responsibleParty":86,"collaborators":26,"id":88,"slug":26,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":26,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":26,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":26,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Huons Biopharma","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of participants whose glabellar lines at maximal frown are improved","Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe.\n\nOnly the participants whose FWS score is 0 or 1 grade when it's assessed and ≥ 2 grade improvement from baseline will be defined as their glabellar lines are improved.","Week4",[14,16,20,23],{"measure":10,"description":11,"timeFrame":15},"Week8, Week12, Week16",{"measure":17,"description":18,"timeFrame":19},"Percentage of participants whose glabellar lines at resting are improved","Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at resting; 0=none, 1=mild, 2=moderate or 3=severe.\n\nOnly the participants whose FWS score is 0 or 1 grade when it's assessed and ≥ 2 grade improvement from baseline will be defined as their glabellar lines are improved.","Week4, Week8, Week12, Week16",{"measure":21,"description":22,"timeFrame":19},"Subject's satisfaction rate after injection","Participants will rate their overall satisfaction by answering the question on a Questionnaire using 7 point scale. 6 and\u002For above grade will be defined as the participant is satisfied about their glabellar lines; (1 = very unsatisfied, 2 = un satisfied, 3 = slightly dissatisfied, 4 = average, 5 = slightly satisfied, 6 = Satisfaction, 7 = very satisfied",{"measure":24,"description":25,"timeFrame":19},"Percentage of subjects who assessed their Glabellar Lines are improved ≥ +2 grade","Subjects will assess their glabellar Lines with a 9 point scale from -4 to +4;(+4 = 100% improvement, +3 = 75% improvement, +2 = 50% improvement, +1 = 25% improvement, 0 = no change, -1 = 25% worse, -2 = 50% worse, -3 = 75% worse, -4 = 100% worse",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":33},"DOUBLE",[34,35],"PARTICIPANT","INVESTIGATOR",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"HU-045 group","EXPERIMENTAL","HU-045 Injection group will receive intramuscular injection of HU-045 to a total of 5 glabellar line sites 4 U\u002F0.1ml each.\n\nHU-045 will be reconstituted from a powder into liquid form by adding 2.5cc of 0.9% sterile saline to the vial, and appropriate volumes will be administered.",[42],"Drug: HU-045",{"label":44,"type":45,"description":46,"interventionNames":47},"Xeomin® group","ACTIVE_COMPARATOR","Xeomin® Injection group will receive intramuscular injection of Xeomin® to a total of 5 glabellar line sites 4 U\u002F0.1ml each.\n\nXeomin® will be reconstituted from a powder into liquid form by adding 2.5cc of 0.9% sterile saline to the vial, and appropriate volumes will be administered.",[48],"Drug: Xeomin®",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":26},"DRUG","HU-045","HU-045 is a medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use.\n\nWhite powder\n\nOther Names:\n\nIncobotulinumtoxinA",[38],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":26},"Xeomin®","Xeomin® is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use.\n\nOther Names:\n\nIncobotulinumtoxinA",[44],[60,65],{"name":61,"role":62,"phone":63,"phoneExt":26,"email":64},"Saeroarum Han","CONTACT","82-70-7492-6032","saeroarum@huonsbiopharma.com",{"name":66,"role":62,"phone":67,"phoneExt":26,"email":68},"Jiwon Kim","82-70-7492-6074","jw.kim@huonsbiopharma.com",[70],{"facility":71,"status":72,"city":73,"state":26,"zip":26,"country":74,"countryCode":26,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Kangbuk Samsung Hospital","RECRUITING","Seoul","South Korea",{"type":76,"coordinates":77},"Point",[78,79],126.9784,37.566,{"lat":79,"lon":78},[82],{"name":83,"role":62,"phone":84,"phoneExt":26,"email":85},"Kim","82-2-2001-2241","susini@naver.com",{"type":87,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100531899",false,"NCT06205797","To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)","A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HU-045 Compared to Xeomin® in Adult Patients With Moderate or Severe Glabellar Lines","Inclusion Criteria:\n\n* 19 Years to 65 Years(Adult, Older Adult)\n* 2(Moderate) and\u002For above of Facial Wrinkle Scale (FWS) score at frown in investigator's live assessment.\n* Subject who signed voluntarily in informed consent form and fully understood about this clinical trial.\n\nExclusion Criteria:\n\n* Subject who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)\n* History of bleeding disorder\n* Infection, dermatological condition or scar at the treatment injection sites\n* Subject who has marked facial asymmetry\n* History of facial nerve palsy or eyebrow\u002Feyelid ptosis\n* History of surgical procedures affecting on the lines of forehead and\u002For middle of the forehead areas\n* History of malignant tumor within 5 years (except for basal cell carcinoma\n* Any disease and condition that, in the view of the investigator, would interfere with study participation\n* History of alcohol or drug addiction\n* Subject who has been treated with any botulinum toxin drug within 6 months\n* Persons who have received the following drugs with systemic muscle relaxant action within 4 weeks of screening\n* Subjects taking more than 1,000 IU\u002Fday of anticoagulants, antiplatelet agents, NSAIDs, or vitamin E within 7 days prior to administration of the investigational drug (excluding low-dose aspirin)\n* A person who has received a retinoid series of medications during the following period as of the time of screening\n* Subjects who have hypersensitivity reaction to investigational drug or local anesthetics\n* History of Anaphylaxis or severe combined allergy disease\n* Subject who has physically untreatable glabellar lines like that can't be spread out even if someone forces it to spread out\n* Pregnant and lactating women F- ertile women and men who have plans to pregnancy and who do not agree to appropriate contraception.\n* Participant who has been treated with any investigational drug within 30 days from screening\n* Subject who are not eligible for this study based on investigator's judgement.",true,"ALL","19 Years","65 Years",{"count":99,"type":100},312,"ESTIMATED","INTERVENTIONAL",[103],"PHASE3","A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HU-045 and Xeomin® in Patients With Moderate to Severe Glabellar Lines",[106],"Glabellar Lines","2024-10-01",{"date":109,"type":110},"2024-10-03","ACTUAL",{"date":112,"type":110},"2024-06-20",{"date":114,"type":100},"2025-03-31",{"name":5,"class":6},1]