NCT02103153已完成不适用
Clinical Evaluation of the Picosure Laser for the Treatment of Unwanted Tattoos
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Tattoo Clearance Percentage Using a Photographic Scale
研究概览
简要总结
The purpose of this study is to evaluate the PICOSURE Laser System for the treatment of unwanted tattoos
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a healthy non-smoking (must have quit 6 months prior) male or female between 18 and 65 years old.
- •Is willing to consent to participate in the study.
- •Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits
- •Has unwanted non-cosmetic tattoo containing red ink, that has not previously been treated, and wishes to undergo laser treatment
排除标准
- •The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- •The subject is hypersensitive to light exposure OR takes photo sensitized medication.
- •The subject has active or localized systemic infections.
- •The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
- •The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- •The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
- •The subject has used Accutane within 6 months prior to enrollment.
- •The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- •The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- •The subject has a history of keloids.
- •The subject has evidence of compromised wound healing.
- •The subject has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
- •The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
结局指标
主要结局
Tattoo Clearance Percentage Using a Photographic Scale
时间窗: 1-3 month follow up post each subject's last treatment, an average of 17.5 months
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0% to 100%, where 0% is 0% tattoo cleared compared to the baseline tattoo, and 100% is 100% of tattoo cleared compared to the baseline tattoo.
次要结局
- Investigator Satisfaction(Baseline and 2 months post last treatment follow up (+/- 1 month))
- Subject Satisfaction(Baseline and 2 months post last treatment follow up (+/- 1 month))
研究者
研究点 (1)
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