Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Percentage of decrease of tattoos 2 months after the third session as compared to baseline on standardized pictures
研究概览
简要总结
The investigators developed an ultra-speed picosecond laser (20ps) with a 20gHz repetition rate that provide very promising results in vitro and in ex vivo skin to remove skin tattoos.
The aim of this study is to evaluate the efficacy and tolerance of a new ultra-speed picosecond laser and to compare it to a nanosecond laser for treating black tattoos.
In a first phase of the study 10 patients with black tattoos will be treated with increasing fluencies of the picosecond laser to the optimal parameters in terms of efficacy and tolerance.
In a second phase, 10 additional subjects with black tattoos will be treated after central randomization on half of the tattoo with the picosecond laser (with the parameters determined in the first phase) and the other half treated with a nanosecond laser.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Black tattoos with surface between 10 and 100 cm²
- •Skin type I to VI
排除标准
- •Childbearing age women
- •Active dermatosis located on the tattoo
- •Personal history of hypertrophic scars or keloids
- •Pigmentary or vascular lesions located on the tattoo
- •Subject taking oral steroid or retinoid or have any risk of delayed healing problems
- •Acquired or hereditary conditions that could leead to a delayed healing
- •Allergy to xylocaine, prilocaine or lidocaine
结局指标
主要结局
Percentage of decrease of tattoos 2 months after the third session as compared to baseline on standardized pictures
时间窗: 2 month after the end of laser utilisation
次要结局
- Evaluation of tolerance(2 months after one session of laser utilisation)
- satisfaction evaluation of depigmanetation tattoo(2 months after one session of laser utilisation)
- Evaluation of Pain with EVA test(2 months after one session of laser utilisation)
- Skin biopsies(immediately after treatment)