NCT05801146招募中3 期
A Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Compare the Efficacy and Safety of HG102 Versus Botox® in Subjects With Moderate to Severe Glabellar Lines
Hugel1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2024年1月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Responder rate of improvement in glabellar lines with Physician's rating line severity
研究概览
简要总结
To evaluate the efficacy and safety of HG102 for moderate to severe Glabellar Lines, non-inferiority compared to Botox® was confirmed and safety was evaluated.
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
- 否
入选标准
- •Subjects that fit all of the criteria below were selected for this clinical trial.
- •Male and female adults from 19 to 65 years old at the time of screening
- •Person with moderate or severe glabellar lines and have received Grade 2-3 according to Physician's Rating Line Severity at maximum frown
- •Person who understands and can comply to the process and visiting schedule of this clinical study
- •Person who gave spontaneous written consent to participate in this clinical study
排除标准
- •Subjects that fit any of the criteria below were excluded from this clinical trial.
- •Person with infection, skin disease, or scar on forehead
- •Person with symptoms of facial palsy or blepharoptosis
- •Person with allergies or hypersensitive reaction history to the ingredients in the investigational product (botulinum toxin formula, serum albumin, etc.)
- •Person who were administered with similar medication within 12 weeks (botulinum toxin type A medication) or 16 weeks (botulinum toxin type B medication)
- •Pregnant and breast-feeding women, men and women in the childbearing age who are planning to get pregnant during the clinical study period, or do not agree to the suitable contraceptive methods
- •Person who participated in another clinical trial, or were given medication for other clinical trials within 4 weeks from screening of 5 times the half-life, which period may be longer
- •Other person who the investigator judges as inappropriate for the clinical trial
研究组 & 干预措施
Botulinum toxin type A(HG102)
Experimental
干预措施: Botulinum Toxin Type A Injection [HG102] (Drug)
Botulinum toxin type A(Botox®)
Active Comparator
干预措施: Botulinum Toxin Type A Injection [Botox] (Drug)
结局指标
主要结局
Responder rate of improvement in glabellar lines with Physician's rating line severity
时间窗: Baseline to week 4
Improvement rate of glabellar lines at maximum frown with Physician's rating line severity at 4 weeks post injection
次要结局
- Responder rate of improvement in glabellar lines with investigator's photo assessment(Baseline to week 4, 8, 12, 16)
- Independent photo evaluator-rated improvement rate of glabellar lines at rest(Baseline to week 4, 8, 12, 16)
- Responder rate of improvement in glabellar lines with Subject's improvement assessment(Baseline to week 4, 8, 12, 16)
- Participant-rated satisfaction after treatment(Baseline to week 4, 8, 12, 16)
- Responder rate of improvement in glabellar lines with Physician's rating line severity(Baseline to week 8, 12, 16)
研究者
研究点 (1)
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