NCT03317574已完成3 期
A Randomized, Double-blind, Active Drug Controlled, Multi-center, Phase Ⅰ/Ⅲ Study to Determine the Efficacy and Safety of Meditoxin® in Treatment of Crow's Feet Line
Medy-Tox1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年8月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 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(FWS)
研究概览
简要总结
to determine the efficacy and safety of Meditoxin® in treatment of crow's feet line
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of at least 20 to 65 years old
- •Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
排除标准
- •Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- •Patients with allergy or hypersensitivity to the investigational drugs or their components
- •Patients who have bleeding tendency or taking anti-coagulant
- •Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
- •Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
- •Patients who are unable to communicate or follow the instructions
- •Patients who are not eligible for this study based on the judgment of an investigator
研究组 & 干预措施
MEDITOXIN
Experimental
干预措施: botulinum toxin type A (Drug)
BOTOX
Active Comparator
干预措施: botulinum toxin type A (Drug)
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(FWS)
时间窗: 4 weeks
The Investigator assessed the severity of the patient'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
未报告次要终点
研究者
研究点 (1)
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