NCT03687736已完成4 期
A Multicenter, Open-Label, Interventional Study to Evaluate Subject Satisfaction of AbobutulinumtoxinA Treatments in Moderate to Severe Glabellar Lines
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines
研究概览
简要总结
An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.
详细描述
Following signature of informed consent and the screening process, eligible subjects were treated at the Baseline visit (Day 0) with abobotulinumtoxinA in the glabellar region. Subjects were re-treated at the Month 6 visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Moderate to Severe Glabellar Lines at Maximum Frown
- •Understands study requirements and signs an informed consent
排除标准
- •Known allergy to any component of study product
- •Pregnant or breast feeding or intending to get pregnant during the study
- •Botulinum toxin treatment in the face within 9 months
结局指标
主要结局
Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines
时间窗: 12 months
Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit.
次要结局
- Evaluate the Impact of Treatment; Psychological Function(Months 1,3,6,7,9 and 12)
- Subject Self-Assessment Using a 4-point Categorical Scale(Months 1,3,6,7,9 and 12)
- Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity(Months 1,3,6,7,9 and 12)
- Subject Satisfaction With Aesthetic Outcome in Treated Area(Months 1,3,6,7,9 and 12)
- Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows(Months 1,3,6,7,9 and 12)
- Onset of Treatment Response(After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit)
研究者
研究点 (7)
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