NCT03369990Unknown2 期
A Randomized, Double-blind, Placebo-controlled, Phase Ⅱ Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects With Benign Masseteric Hypertrophy
Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 98 人开始时间: 2017年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 98
- 主要终点
- Reduction amount of masseter muscle thickness
研究概览
简要总结
This study is A Randomized, Double-blind, Placebo-controlled, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 treatment, including double jaw surgery, laser, thread treatment etc. in 12 months.
- •Subject who had previously received botulinum toxin within 3 months 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
Placebo
Placebo Comparator
Normal Saline
干预措施: Placebos (Drug)
Botulinum toxin type A
Experimental
DWP450
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Reduction amount of masseter muscle thickness
时间窗: At 12 weeks
Reduction amount of masseter muscle thickness by Ultrasonography
次要结局
- Overall satisfaction of subject(At 4, 8, 12, 16 weeks)
- Reduction amount of masseter muscle thickness(At 4,8,16 weeks)
- Reduction amount of lower face volume(At 4, 8, 12, 16 weeks)
研究者
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