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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Percentage of participants whose glabellar lines at maximal frown are improved
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HU-045 group
HU-045 Injection group will receive intramuscular injection of HU-045 to a total of 5 glabellar line sites 4 U/0.1ml each.
HU-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.
干预措施: HU-045 (Drug)
Xeomin® group
Xeomin® Injection group will receive intramuscular injection of Xeomin® to a total of 5 glabellar line sites 4 U/0.1ml each.
Xeomin® 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.
干预措施: Xeomin® (Drug)
结局指标
主要结局
Percentage of participants whose glabellar lines at maximal frown are improved
时间窗: Week4
Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe. Only 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.
次要结局
- Percentage of participants whose glabellar lines at maximal frown are improved(Week8, Week12, Week16)
- Percentage of participants whose glabellar lines at resting are improved(Week4, Week8, Week12, Week16)
- Subject's satisfaction rate after injection(Week4, Week8, Week12, Week16)
- Percentage of subjects who assessed their Glabellar Lines are improved ≥ +2 grade(Week4, Week8, Week12, Week16)