[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531899":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":58,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Huons Biopharma","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: HU-045",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Drug: Xeomin®",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"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",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"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",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Saeroarum Han","CONTACT","82-70-7492-6032","saeroarum@huonsbiopharma.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Jiwon Kim","82-70-7492-6074","jw.kim@huonsbiopharma.com",[42],{"facility":43,"status":44,"city":45,"state":26,"zip":26,"country":46,"countryCode":26,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Kangbuk Samsung Hospital","RECRUITING","Seoul","South Korea",{"type":48,"coordinates":49},"Point",[50,51],126.9784,37.566,{"lat":51,"lon":50},[54],{"name":55,"role":34,"phone":56,"phoneExt":26,"email":57},"Kim","82-2-2001-2241","susini@naver.com",{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100531899","phase-3-to-evaluate-hu-045-in-the-treatment-of-glabellar-linesphase-iii-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":72,"type":73},312,"ESTIMATED","INTERVENTIONAL",[76],"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",[79],"Glabellar Lines","2024-10-01",{"date":82,"type":83},"2024-10-03","ACTUAL",{"date":85,"type":83},"2024-06-20",{"date":87,"type":73},"2025-03-31",{"name":5,"class":6},1]