NCT02110095已完成不适用
Picosure Alexandrite 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
- 15
- 试验地点
- 2
- 主要终点
- Number of Patients With Tattoo Clearance
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a healthy male or female between 18 and 85 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.
- •The tattoo must include red pigment.
排除标准
- •Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- •Is hypersensitive to light exposure OR takes photo sensitized medication.
- •Has active or localized systemic infections.
- •Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
- •Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- •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.
- •Has used Accutane within 6 months prior to enrollment.
- •Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- •Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- •Has a history of keloids.
- •Has evidence of compromised wound healing.
- •Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
- •Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
- •Is allergic to topical lidocaine or topical steroids.
结局指标
主要结局
Number of Patients With Tattoo Clearance
时间窗: 2 months post last treatment
Tattoo clearance will be measured using baseline and 2 month post treatment photos using a photographic scale. The scale ranges from 0 to 10, where 10 is 100% improvement from the baseline photo.
次要结局
- Physician Satisfaction Questionnaire(2 months post last treatment)
研究者
研究点 (2)
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