NCT06212960已完成1 期
Double-blind, Randomized, Parallel Design, Active-controlled Phase 1 Clinical Trial to Evaluate the Efficacy and Safety of DWP712 and Botox® in Adult Patients in Need of Moderate to Severe Glabellar Lines
Daewoong Pharmaceutical Co. LTD.2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2023年11月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of occurrences for grade 3 or higher adverse drug reactions (ADRs) according to CTCAE 5.0
研究概览
简要总结
To evaluate the safety of 12-week administration 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 facial wrinkle scale (FWS) score of visual appearance of glabellar lines ≥2 (moderate) at maximum frown as assessed by the investigator at screening
排除标准
- 未提供
结局指标
主要结局
Number of occurrences for grade 3 or higher adverse drug reactions (ADRs) according to CTCAE 5.0
时间窗: At 4, 8, 12 week after the injection
次要结局
未报告次要终点
研究者
研究点 (2)
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