The Efficacy of the Cupola Ultrasonic Tattoo Removal Device: A Prospective Single Blinded, Before-After Study Design
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Tattoo Removal Efficiency
研究概览
简要总结
The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.
详细描述
The Cupola system is a non-invasive device for pigment/tattoo removal based on ultrasound technology. The safety of the device was demonstrated in a previous pilot study approved by the Herzog Helsinki committee #167-09, Ministry of Health April 2010 #HT-5293) showing that no risk was associated with the procedure.
This study is designed to determine the efficacy of the device for tattoo removal in up to 6 treatments in different treatment intervals. Three areas of the tattoo that are similar in size, color, and intensity will be chosen. One area will not be treated; the second will receive 6 treatments in 2-3 week intervals; the third will receive 3 treatments in 4-6 week intervals. The evaluations will include color measurements, photography, subject comfort and skin condition.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of tattoo - more than 1 year since application
- •Type - decorative (not cosmetic)
- •Not previously treated
- •At least 18 years of age
- •Agrees to sign the Informed Consent
- •Willingness to remove tattoo
- •Willingness to have photographs and color measurements of the treated area taken and to be used for marketing and educational presentation and/or publications
- •Willingness to follow the treatment schedule and post treatment care requirement for tattooing and removal
- •Not planning to remove the tattoo in a different procedure during the time of the experiment
排除标准
- •Skin conditions
- •Skin type 5 and 6
- •History of keloid formation
- •Active herpes simplex
- •Psoriasis or vitiligo
- •Other medical conditions
- •HIV or Hepatitis
- •Pregnancy or intention to become pregnant in the next 6 months
- •No allergic reaction during the tattooing process.
- •Currently taking anticoagulant medication, blood thinners, steroids or immunosuppressive
- •Taking isotretinoin (Accutane) currently or within the last 6 months
- •Minocyclin
结局指标
主要结局
Tattoo Removal Efficiency
时间窗: 6 months (termination)
Extent of Tattoo removal is quantified in 2 methods based on photographs taken at the baseline visit and at the termination visit: 1. Scoring by independent dermatologist 2. Measuring pigment clearance using image analysis
次要结局
- Tolerability Score(0, 2, 4, 6, 8, 10 weeks (after every treatment))