NCT04249583已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 300
- 试验地点
- 26
- 主要终点
- Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month.
研究概览
简要总结
The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe GL.
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
- 是
入选标准
- •Male or female 18 years of age or older.
- •Moderate to severe GL at maximum frown as assessed by the Investigator.
- •Moderate to severe GL at maximum frown as assessed by the subject.
排除标准
- •Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
- •Female who is pregnant, breast feeding, or intends to conceive a child during the study.
- •Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP) or any botulinum toxin serotype.
结局指标
主要结局
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month.
时间窗: One Month
The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe)
次要结局
- Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown(One Month)
研究者
研究点 (26)
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