NCT06021418进行中（未招募）不适用
A Single Center, Randomized, Subject and Evaluator Blinded, Split-face, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of DKB-119 in Crow's Feet
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Crow's feet
研究概览
简要总结
To prove the non-inferiority of DKB-119 by evaluating the injecting efficacy and safety DKB-119 and control for patients in crow's feet
详细描述
A single center, randomized, subject and evaluator blinded, split-face, pivotal clinical trial
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, Outcomes Assessor)
盲法说明
- Blind: Participant, Outcomes Assessor
- Un-blind: Investigator(Care Provider)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who are over 19 under 70 ages.
- •Those who score 2 or more in the LCL severity evaluation.
- •Those who have visually symmetrical crow's feet on both sides.
排除标准
- •Pregnancy and lactating women.
结局指标
主要结局
Crow's feet
时间窗: 18 weeks
Difference in improvement rate (percentage)
次要结局
- GAIS(Global Aesthetic Improvement Scale)(8, 10, 18 weeks)
- Crow's feet(8, 10 weeks)
- LCL(Lateral Canthal Line) Severity(8, 10, 18 weeks)
研究者
研究点 (1)
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