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To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)

RecruitingPhase 3Ages 19 Years - 65 YearsAllHuons Biopharma
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 19 Years to 65 Years(Adult, Older Adult) * 2(Moderate) and/or above of Facial Wrinkle Scale (FWS) score at frown in investigator's live assessment. * Subject who signed voluntarily in informed consent form and fully understood about this clinical trial. Exclusion Criteria: * Subject who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.) * History of bleeding disorder * Infection, dermatological condition or scar at the treatment injection sites * Subject who has marked facial asymmetry * History of facial nerve palsy or eyebrow/eyelid ptosis * History of surgical procedures affecting on the lines of forehead and/or middle of the forehead areas * History of malignant tumor within 5 years (except for basal cell carcinoma * Any disease and condition that, in the view of the investigator, would interfere with study participation * History of alcohol or drug addiction * Subject who has been treated with any botulinum toxin drug within 6 months * Persons who have received the following drugs with systemic muscle relaxant action within 4 weeks of screening * Subjects taking more than 1,000 IU/day of anticoagulants, antiplatelet agents, NSAIDs, or vitamin E within 7 days prior to administration of the investigational drug (excluding low-dose aspirin) * A person who has received a retinoid series of medications during the following period as of the time of screening * Subjects who have hypersensitivity reaction to investigational drug or local anesthetics * History of Anaphylaxis or severe combined allergy disease * Subject who has physically untreatable glabellar lines like that can't be spread out even if someone forces it to spread out * Pregnant and lactating women F- ertile women and men who have plans to pregnancy and who do not agree to appropriate contraception. * Participant who has been treated with any investigational drug within 30 days from screening * Subject who are not eligible for this study based on investigator's judgement.
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What it tests

  • HU-045
  • Xeomin®
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Where

1 site
Kangbuk Samsung Hospital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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