NCT02236312已完成2 期
A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Three Doses of Botulinum Toxin in the Treatment of Moderate to Very Severe Glabellar Frown Lines
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 359
- 试验地点
- 1
- 主要终点
- Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a single treatment of three different doses of botulinum toxin compared to placebo, in the treatment of moderate to very severe glabellar frown lines.
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
- •Moderate to Very Severe glabellar lines at maximum frown as assessed by the subject and the Investigator and at least Mild glabellar lines at rest
排除标准
- •Any previous treatment with any botulinum toxin
- •Rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart
- •Any previous insertion of any permanent or semi-permanent material, hyaluronic acid or collagen fillers to the glabellar region
- •Any history of facial surgery above the lower orbital rim
- •Any planned facial surgery or aesthetic procedure during the study period
- •Ablative skin resurfacing or chemical peels above the lower orbital rim in the previous 12 months or during the study period
研究组 & 干预措施
Botulinum Toxin 30 units
Experimental
I.M. injection
干预措施: Botulinum Toxin Type A (Drug)
Botulinum Toxin 45 units
Experimental
I.M. injection
干预措施: Botulinum Toxin Type A (Drug)
Botulinum Toxin 60 units
Experimental
I.M. injection
干预措施: Botulinum Toxin Type A (Drug)
Placebo
Placebo Comparator
I.M. injection
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin
时间窗: 14 Days
Reduction in glabellar frown line severity is derived separately for the Investigator and the subject assessment, using a validated photo scale, at maximum frown on Day 14.
次要结局
未报告次要终点
研究者
研究点 (1)
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