Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown
研究概览
简要总结
This is a safety and efficacy study of botulinum toxin type A in subjects with 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate or severe glabellar frown lines
- •Female or male, 30 to 65 years of age in good general health
- •Women of childbearing potential must agree to use an effective method of birth control during the course of the study
- •Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response
排除标准
- •Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
- •Muscle weakness or paralysis, particularly in the treatment area
- •Active skin disease or infections or irritation at the treatment area
- •Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart
- •Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body
研究组 & 干预措施
Dose C
Dose C: Botulinum Toxin Type A
干预措施: Botulinum Toxin Type A (Biological)
Dose D
Dose D: Botulinum Toxin Type A
干预措施: Active Comparator botulinum toxin (Biological)
Dose E
Dose E: Placebo
干预措施: Placebo Comparator (Biological)
Dose B
Dose B: Botulinum Toxin Type A
干预措施: Botulinum Toxin Type A (Biological)
Dose A
Dose A: Botulinum Toxin Type A
干预措施: Botulinum Toxin Type A (Biological)
结局指标
主要结局
Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown
时间窗: Week 24
Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity
时间窗: Up to Week 36
次要结局
未报告次要终点