NCT04830345已完成3 期
A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety of ATGC-100 Versus Botox in Subjects With Moderate to Severe Glabellar Lines
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Proportion of patients with improvement of glabellar lines at maximum frown
研究概览
简要总结
Efficacy and safety of ATGC-100 are assessed in subjects 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy male and female aged 19 to 65 years old
- •Participants with Facial Wrinkle Scale (FWS) score of > 2 at maximum frown at screening
- •Participants willing to follow the study procedures and schedules
- •Participants willing to give written informed consent to participate in the trial
排除标准
- •Participants with severe glabellar lines that cannot be improved physical method
- •Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
- •Participants with known hypersensitivity to any component of the study drug
- •Participant who has skin disorder including infection and scar on injection site
结局指标
主要结局
Proportion of patients with improvement of glabellar lines at maximum frown
时间窗: 4 weeks post injection compared to baseline
Improvement rate of glabellar lines at maximum frown with Physician's Facial wrinkle scale (FWS)
次要结局
未报告次要终点
研究者
研究点 (1)
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