NCT01842815已完成不适用
Evaluation of the 755nm Alexandrite for Unwanted 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
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 a 755nm Alexandrite laser.
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 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
时间窗: Post Treatment 3 (18 Weeks Post Baseline)
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
次要结局
未报告次要终点
研究者
研究点 (2)
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