NCT04225260已完成3 期
A Multicenter, Open-Label Study to Evaluate the Safety of QM1114-DP for the Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal 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
- 902
- 试验地点
- 60
- 主要终点
- Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown
研究概览
简要总结
This is a phase 3, multicenter, open-label study to evaluate the safety of QM1114-DP for the long term treatment of moderate to severe Glabellar (Frown) Lines (GL) and Lateral Canthal Lines (Crow's Feet and LCL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 at least 18 years of age.
排除标准
- •Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
- •Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).
- •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 Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown
时间窗: Week 4
4-point scale
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile
时间窗: Week 4
4-point scale
次要结局
未报告次要终点
研究者
研究点 (60)
Loading locations...
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