A Multi-center, Open Label, Multiple Dose, Phase II Trial to Demonstrate the Safety of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Evolus, Inc.
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
研究概览
简要总结
The purpose of this study is to demonstrate the safety of multiple doses of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in treatment of moderate to severe glabellar lines in adult subjects.
详细描述
Three hundred and fifty subjects will be enrolled and injected with the study drug DWP-450 over the course of the 365 day study.
Subjects with moderate or severe glabellar lines at maximum frown on the 4 point Glabellar Line Scale (GLS, 0=none, 1= mild, 2=moderate, 3=severe), as judged by the investigator, will be eligible for injection with DWP-450. After each injection, subjects will be followed and are eligible for a repeat injection if their GLS is ≥2 at maximum frown, as judged by the Investigator. If a subject does not have a GLS≥2 they will be followed monthly until eligible for repeat treatment.
Subjects may receive up to a maximum of 4 treatments and will be followed for 365 days from initial treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Botulinum neurotoxin, Type A
DWP-450 (Botulinum purified neurotoxin, Type A) Injection
干预措施: Botulinum purified neurotoxin, Type A (Biological)
结局指标
主要结局
The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
时间窗: 365 Days
The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.
次要结局
未报告次要终点