NCT01797094已完成3 期
BOTOX® in the Treatment of Upper Facial Lines in Japan
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
研究概览
简要总结
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the treatment of upper facial lines (Crow's Feet Lines and 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe Crow's Feet Lines and Frown Lines
排除标准
- •Current or previous botulinum toxin treatment of any serotype
- •Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
- •Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months
- •Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year
- •Medium-depth or deep facial peels within 5 years
- •Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, periorbital treatment with fillers, implantation or transplantation)
结局指标
主要结局
Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
时间窗: Day 30
The Investigator assessed the severity of the participant's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.
次要结局
- Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30(Baseline, Day 30)
- Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30(Baseline, Day 30)
- Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline(Baseline, Day 30)
- Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines (SGA-CFL)(Day 30)
- Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30(Baseline, Day 30)
- Percentage of Participants Mostly or Very Satisfied With Their Crow's Feet Lines on the Facial Line Satisfaction Questionnaire(Day 30)
研究者
研究点 (1)
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