NCT04294251已完成3 期
A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase Ⅲ Study to Evaluate the Efficacy and Safety of NABOTA® in Subjects With Benign Masseteric Hypertrophy
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年3月4日最近更新:
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
- 180
- 试验地点
- 1
- 主要终点
- Change from baseline in masseter muscle thickness
研究概览
简要总结
This Study is A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject over 18 years of age and written informed consent is obtained.
- •Subject with Benign Masseter Hypertrophy.
- •Subject who has Bisymmetry of masseter at visual assessment.
- •Subjects who meets thickness of Masseter muscle by ultrasonography.
- •Subjects who can and will comply with the requirements of the protocol.
排除标准
- •Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
- •Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 52 weeks prior to the study entry.
- •Subject who had previously received botulinum toxin within 12 weeks prior to the study entry.
- •Subject with known hypersensitivity to botulinum toxin.
- •Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study period.
- •Subjects who are not eligible for this study at the discretion of the investigator.
研究组 & 干预措施
DWP450
Experimental
干预措施: DWP450 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in masseter muscle thickness
时间窗: 12 weeks
Change from baseline in masseter muscle thickness by Ultrasonography
次要结局
- Change from baseline in lower face volume(24 weeks)
- Change from baseline in masseter muscle thickness(24 weeks)
- Overall satisfaction of subject: questionnaire(24 weeks)
研究者
研究点 (1)
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