NCT01629875已完成3 期
Efficacy and Safety of DWP450 Compared With Botox in Patients With Moderate to Severe Glabellar Line: Active Controlled, Double-blind, Randomized, Multi-center, Phase I/III Clinical Trial
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment
研究概览
简要总结
The purpose of this study was to observe Efficacy and safety of DWP450 compared with Botox in moderate to severe glabellar line patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DWP450
Experimental
干预措施: Generic equivalent of Clostridium Botulinum A Toxin (Drug)
Botox
Active Comparator
干预措施: Botox (Clostridium Botulinum A Toxin) (Drug)
结局指标
主要结局
At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment
时间窗: At 4 weeks
At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment
次要结局
- At 8, 12, 16 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment(At 8, 12, 16 weeks)
研究者
研究点 (1)
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