Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- The First Visit Onset of Efficacy as Measured by Subject Assessment
研究概览
简要总结
This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)
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
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects of any race, 35-55 years of age
- •Moderate to severe glabellar wrinkles (lines between the eyebrows)
排除标准
- •Previous botulinum toxin therapy
- •Subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
- •Subjects planning a facial cosmetic procedure or visible scars
- •Previous cosmetic surgery to the upper face
- •Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function
- •History of facial nerve palsy
- •Allergy or sensitivity to any component of the study medication
结局指标
主要结局
The First Visit Onset of Efficacy as Measured by Subject Assessment
时间窗: 14 Days
The first visit onset of efficacy as measured by subject assessment. Onset is determined by a yes/no answer to the question "Since being injected, have you noticed any effect on the appearance of your frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.
The First Visit Onset of Efficacy as Measured by Physician Assessment
时间窗: 14 Days
The first visit onset of efficacy as measured by physician assessment. Onset is determined by a yes/no answer to the question "Since injecting the patient, have you noticed any effect on the appearance of the patient's frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.
次要结局
- Average Subject Assessment Score in Improvement of Appearance of Frown Lines(14 Days)
- Percentage of Patients Reporting Self-Perception of Age (SPA)(Baseline, Day 14)
- Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score(Baseline, Day 14)