NCT01379365已完成2 期
Cryo-Touch III Refinement Study Investigational Plan
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Wrinkle Severity and incidence of device-related serious adverse events
研究概览
简要总结
This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch III device for the treatment of glabellar and/or forehead wrinkles.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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 2 in animation on the 5-point Wrinkle Scale (5WS)*
- Subject has signed institutional review board (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
- Ptosis
- Excessive dermatochalasis
- Deep dermal scarring
- Thick sebaceous skin
- History of neuromuscular disorder
- Chronic dry eye symptoms
- Allergy or intolerance to lidocaine
- Other local skin condition (eg, skin infection) at target treatment site
- Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation
研究组 & 干预措施
Treatment
Experimental
干预措施: Cryo-Touch III (Device)
结局指标
主要结局
Wrinkle Severity and incidence of device-related serious adverse events
时间窗: Up to 4 months
* Effectiveness endpoint: Wrinkle severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point grading scale. * Safety endpoint: Incidence of device-related serious adverse events (DSAE).
次要结局
- Independent Assessment(Up to 4 months)
- Global assessment(Up to 4 months)
- Wrinkle Severity(Up to 4 months)
研究者
研究点 (1)
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标识符
- NCT 编号
- NCT01379365
- 其他研究编号
- MS-4500, MS-4500
日期
- 首次提交
- (15年前)
- 首次发布
- (15年前)
- 主要完成日期
- (11年前)
- 研究完成日期
- (11年前)
- 最近核实
- (11年前)
- 最近更新
- (11年前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否
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