NCT02110121已完成不适用
Picosure Alexandrite Laser and Revlite Nd:Yag 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
- 63
- 试验地点
- 2
- 主要终点
- Tattoo Clearance
研究概览
简要总结
The purpose of this study is to evaluate the Picosure and Revlite Laser Systems for the treatment of unwanted tattoos.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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.
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 sensitizing 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 keloid scar formation.
- •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.
- •The subject has red tattoo ink allergy
结局指标
主要结局
Tattoo Clearance
时间窗: 2 months post each patient's last treatment, approximately 15 months
Clearance will be measured using a blinded photograph evaluation scale. This ranges from 0 to 3, where a score of 0 is 0-25%, 1 is 25-50% clearance rating, 2 is 50-75%, and 3 is \>75%. Photographs will be taken of the subjects at baseline and post treatment. The results will be compared to determine clearance.
次要结局
未报告次要终点
研究者
研究点 (2)
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