NCT01167140已完成2 期
Cryo-Touch II for the Treatment of Wrinkles
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Number of Participants With Effectiveness and Safety Success
研究概览
简要总结
This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 30-70 years
- •Subject has a glabellar and/or forehead wrinkle rating by investigator of at least 1 at rest on the 5-point Wrinkle Scale (5WS)*
- •Subject has signed IRB-approved informed consent form
排除标准
- •Subject takes any medication or dietary supplement regularly that affects blood clotting (e.g., Coumadin, aspirin, clopidogrel) or increases the risk of bleeding/bruising
- •Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites
- •The investigator is unable to substantially lessen facial lines by physical separation
- •Subject has undergone another facial cosmetic procedures at or above the level of the cheekbones within the past 6 months
- •Subject is participating in another facial cosmetic research study
- •Patient has any of following conditions:
- •History of facial nerve palsy
- •Marked facial asymmetry
- •Excessive dermatochalasis
- •Deep dermal scarring
- •Thick sebaceous skin
- •History of neuromuscular disorder
- •Chronic dry eye symptoms
- •Allergy or intolerance to lidocaine
结局指标
主要结局
Number of Participants With Effectiveness and Safety Success
时间窗: Up to 4 months
* Effectiveness success: an improvement in line severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point wrinkle scale * Safety success: the absence of a device-related serious adverse event (DSAE)
次要结局
- Participants With One Point Improvement in Line Severity(Baseline and up to 4 months)
- Participants With an Improvement in Global Appearance(Up to 4 months)
研究者
研究点 (2)
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