Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
研究概览
简要总结
A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated with facial laser resurfacing.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate or severe frown lines
- •facial laser treatment between 4 to 8 weeks prior to Day 1
排除标准
- •previous use of botulinum toxin for any indication
- •diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- •microdermabrasion or superficial peels, permanent make-up to the brow and forehead area within the last 3 months
- •facial cosmetic procedures within the last 6 Months
- •treatment to forehead, brow, nose or midface areas with any filler within the last 12 months
- •use of a new topical skin care product within 1 month of the screening
- •any prior forehead or periorbital surgery or brow lift
- •deep dermal scarring, excessively thick sebaceous skin, and/ or loss of skin elasticity
- •any facial skin infection or unhealed skin lesion
- •pregnant or breast-feeding
研究组 & 干预措施
botulinum toxin Type A
20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
干预措施: botulinum toxin Type A (Biological)
结局指标
主要结局
Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction
时间窗: Day 1, Day 30
The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.
次要结局
- Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction(Day 1, Day 14, Day 90, Day 120)
- Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction(Day 1, Day 14, Day 30, Day 90, Day 120)
- Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest(Day 1, Day 14, Day 30, Day 90, Day 120)
- Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest(Day 1, Day 14, Day 30, Day 90, Day 120)