NCT01811017撤回不适用
Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Photographic Evaluation of Tattoo Clearance
研究概览
简要总结
Compare the efficacy of the 755nm Alexandrite laser to the nanosecond 755nm Alexandrite laser for the removal of unwanted tattoos using photographic evaluation and histological findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Is willing to consent to participate in the study.
- •Is willing to shield the tattoo completely from sun exposure
- •Signs informed consent form
- •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
- •Subjects who are unwilling to consent to tattoos
- •Subjects mentally ill or incompetent
- •Subjects is unwilling to have photographs taken and used in publications or scientific presentations
- •Subjects who are prisoners
- •Subjects with recent sun exposure and suntan in the area to be treated
- •Allergic tattoos (hypersensitivity to tattoo ink)
- •History of vitiligo or keloidal scarring
- •Tattoos located on the neck or face including cosmetic tattoos
- •Subjects unwilling to tolerate partial removal of the tattoo in this study
- •Infection or skin disease in the area to be treated
- •Subjects who are immunosuppressed (e.g. HIV)
- •Subject is pregnant or nursing
- •Use of oral isotretinoin within past 12 months
- •History of squamous cell carcinoma or melanoma
- •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
Photographic Evaluation of Tattoo Clearance
时间窗: up to 3 months post last treatment
次要结局
- Subject biopsy sampling(up to 3 months post last treatment)
研究者
研究点 (2)
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