A Double-blind, Randomized, Active-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP712 Inj. in Subjects With Moderate to Severe Glabellar Lines
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Percentage of subjects with glabellar line improvement* rate at maximum frown based on the investigator's on-site assessment at 4 weeks after IP administration
研究概览
简要总结
To evaluate the efficacy and safety of DWP712 Inj. 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
- 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
- •Subjects with a facial wrinkle scale (FWS) score of ≥2 (moderate) for glabellar lines at maximum frown in the investigator's on-site assessment at screening
排除标准
- •Subjects with glabellar lines that cannot sufficiently be improved by physical attempts, e.g., glabellar lines not flattened by hand, in the judgment of the investigator
研究组 & 干预措施
DWP712 inj.
The investigational product will be administered by a single intramuscular injection, and 4 U/0.1 mL of the IP will be injected into a total of 5 sites, totaling 20 U/0.5 mL.
干预措施: DWP712 inj. (Biological)
Botox® 100 Units
The investigational product will be administered by a single intramuscular injection, and 4 U/0.1 mL of the IP will be injected into a total of 5 sites, totaling 20 U/0.5 mL.
干预措施: Botox® 100 Units (Biological)
结局指标
主要结局
Percentage of subjects with glabellar line improvement* rate at maximum frown based on the investigator's on-site assessment at 4 weeks after IP administration
时间窗: At 4 weeks after IP administration
Improvement means FWS grade of "0" or "1" with a ≥2-point improvement from baseline
次要结局
未报告次要终点