A Study of Subject Satisfaction With BOTOX® Cosmetic Treatment in Facial Rhytides
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 125
- 主要终点
- Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ)
研究概览
简要总结
This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar lines and crow's feet 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glabellar lines and crow's feet lines
- •No prior use of botulinum toxin therapy of any serotype for any reason
排除标准
- •Previous facial cosmetic surgery, tissue grafting, or tissue augmentation with silicone or fat or other permanent fillers
- •Planning a facial cosmetic procedure during the study period
- •Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, and/or amyotrophic lateral sclerosis
- •Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)
研究组 & 干预措施
BOTOX®
BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.
干预措施: onabotulinumtoxinA (Biological)
Placebo
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ)
时间窗: Day 60
Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.
次要结局
- Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ(Day 60)
- Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ(Day 90)
- Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS(Day 30)
- Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ(Day 60)
- Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ(Day 60)
- Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ(Day 90)
- Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ(Day 90)
- Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS(Baseline, Day 30)
- Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ(Day 90)