Comparison of safety and efficacy of 2 brands of Botulinum Toxin A for the treatment of crow’s feet: A Split face study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To study the safety and efficacy of Botulinum toxin A on the crow’s feet
研究概览
简要总结
Facialwrinkles are classified as dynamic wrinkles that occur with facial expressionand static wrinkles that appear at rest. Static wrinkles are caused bycutaneous sagging or a decrease in the subcutaneous fat layer and atrophy ofthe dermis1. Dynamic wrinkles, caused by repeated muscularcontraction, can be improved with botulinum toxin injection.Crow’s feet, are horizontal lines in thelateral canthal area that appear when smiling. Crow’s feet are predominantlyassociated with the action of the lateral orbicularis oculi muscle andpartially with that of the zygomaticus muscle.2Botulinum toxin injection is the mostcommonly performed nonsurgical procedure worldwide.3
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •18 years and above Both Male and Female Moderate to severe lateral canthal lines associated with orbicularis oculi activity.
排除标准
- •a)Known Hypersensitivity to Botulinum Toxin b)Subjects with neuromuscular disorders (myasthenia gravis, Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis, or motor neuropathy) c)Subjects who used medications that interfere with the neuromuscular function, such as aminoglycoside antibiotics and curare-like agents, within 4 weeks before screening.
- •d)Subjects with a previous injection of botulinum toxin Type A within 3 months or cosmetic procedures associated with crow’s feet e)Pregnancy and lactation.
结局指标
主要结局
To study the safety and efficacy of Botulinum toxin A on the crow’s feet
时间窗: After 3 months
次要结局
- The severity of crow’s feet on both sides will be assessed, using a facial wrinkle scale (FWS) with grades of 0 (none), 1 (mild), 2 (moderate), and 3 (severe) at maximum smile and at rest. Day 0, Week 4, Week 8 And Week 12(After 3 months)