NCT01754207已完成不适用
Evaluation of the 755nm Alexandrite Laser for the Treatment of Tattoos
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Tattoo Clearance Using Photographic Evaluation
研究概览
简要总结
The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using the 755nm Alexandrite laser.
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.
- •Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them.
- •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
- •Is hypersensitive to light exposure.
- •Has active localized or systemic infection.
- •Is taking medication(s) for which sunlight is a contraindication.
- •Has a history of squamous cell carcinoma or melanoma.
- •Has a history of keloid scarring.
- •Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
- •Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- •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 allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
- •Has any other reason determined by the physician to be ineligible to participate in the study.
结局指标
主要结局
Tattoo Clearance Using Photographic Evaluation
时间窗: up to 3 months post last treatment
2D photography comparing pre and post treatment photos, where the percentage of tattoo clearance between the photos was determined by the evaluator.
次要结局
未报告次要终点
研究者
研究点 (2)
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