NCT02877667已完成不适用
Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Soliton
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Demonstrate that multiple passes with Quality Switched Yag laser is safe based on assessment of Adverse Events
研究概览
简要总结
Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.
详细描述
A non-significant risk, single center, prospective device trial to evaluate the number of passes of Q-Switch laser treatment that can be completed with a Q-Switch Laser alone compared to use of the Soliton Planar Acoustic Wave Device System (AWD) System as an accessory to Q-switched laser in tattoo reduction treatment.
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
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Range of Fitzpatrick skin color scores I to III
- •Tattoo with location on arms, legs, and torso only, and accessible to AWD treatment head. Black ink only. Other ink colors may be present, but areas of black only tattoo should meet criteria described as: minimum 1" x 3" tattoo with at least 30-50% consistent coverage (see fig 1).
- •Tattoo age between 1 and 20 years.
- •Professionally applied.
排除标准
- •Subject is pregnant or planning to become pregnant during the duration of the study.
- •Prior tattoo removal procedures on target tattoo.
- •Self-applied or amateur tattoo.
- •Tattoo layering (additional tattoo placed over an older tattoo to hide it) on target tattoo.
- •Metal or plastic implants in the area of the tattoo (pacemaker, implanted defibrillator, stent, or implants in the hips, knees, elbows, etc.).
结局指标
主要结局
Demonstrate that multiple passes with Quality Switched Yag laser is safe based on assessment of Adverse Events
时间窗: 1 day
Safety assessments included reported Adverse Events as a result of physician examination
次要结局
- Efficacy comparison of tattoo fading of laser versus laser and Acoustic Wave Device treated tattoos .(12 weeks)
研究者
研究点 (2)
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