A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Assess Aesthetic Improvement and Onset of QM1114-DP Treatment Effect in Subjects With Moderate to Severe Glabellar Lines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1
研究概览
简要总结
The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar 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
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •Male or Female 18 years 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.
研究组 & 干预措施
Active arm - QM1114-DP
a Botulinum Toxin Type A (BoNT-A)
干预措施: QM1114-DP (Biological)
Inactive arm - Placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1
时间窗: At Month 1
Participant assessment at Month 1 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a participant who responded "improved," "much improved," or "very much improved" on the participant GAIS at maximum frown. Missing data is imputed as no change (non-responder).
次要结局
- Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card(At Days 0 through 7 post-treatment)
- Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12(From Day 1 through Month 12)