Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Soliton
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Tattoo clearance
研究概览
简要总结
To further evaluate accelerated fading resulting from additional treatment sessions of Soliton AWD as accessory to laser in tattoo reduction treatment.
详细描述
To further evaluate accelerated fading resulting from additional treatment sessions of multi-pass Q-Switched laser with the Soliton Planar Acoustic Wave Device System (AWD) 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
- 否
入选标准
- •Range of Fitzpatrick skin color scores I to III
- •The identical tattoo located on the arms, legs, and torso treated by Q-Switched laser and Laser + AWD during Soliton's previous 2016-001 clinical trial
- •Black ink only. Other ink colors may be present, but areas of black only tattoo should meet inclusion criteria
- •Approximately 1" x 3" tattoo with at least 30-50% of the treatment area containing black tattoo ink
排除标准
- •Subject is pregnant or planning to become pregnant during the duration of the study
- •Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)
- •Skin disorders (skin infections or rashes, scarring, moles,birthmarks, psoriasis, etc.)
- •Any surgical procedure in the prior 3 months, or planned during the duration of the study
- •Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, etc.
- •Moderate to heavy tanning on and around the tattoo to be treated as determined by the Principle Investigator.
结局指标
主要结局
Tattoo clearance
时间窗: 12 weeks
To evaluate changes in accelerated fading of previously treated tattoos from original treatment with additional treatment sessions of Soliton Acoustic Wave Device as an accessory to laser treatment through comparison of photographic evidence. Changes are measured by comparing photos of the tattoos after the original treatment to photos of the tattoos after additional treatment.
次要结局
- Incidence of Treatment Emergent Adverse Events for Safety Reporting(12 weeks)