Evaluation of the Safety and Efficacy of the DeScribe™ Laser Tattoo Removal Accessory Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of passes with Describe patch
研究概览
简要总结
This is a prospective study to evaluate the efficacy and safety of an accessory for laser tattoo removal in allowing multiple passes within a single treatment session.
详细描述
This is a prospective study to evaluate the efficacy and safety of an accessory for laser tattoo removal in allowing multiple passes within a single treatment session. One half of the tattoo will be randomly assigned laser treatment utilizing the Device (the "Device half"); the other half will receive laser treatment without the Device and serve as the control (the "Control half"). Based on statistical analysis sample size calculations, 30 subjects will be enrolled. The tattoo must be no larger than approximately 2 ½" x 6" or 3" x 5" in size, such that ½ of the tattoo can be covered with a single patch. Each subject will receive a single Treatment Session consisting of 5 minutes. Investigators will administer the standard laser treatment to both the Device and Control sites using well-established tattoo-removal treatment parameters for the laser used. Subjects will return for follow up approximately one month post-treatment. The presence of side effects and adverse events will be assessed and recorded for both Device and Control sites immediately after treatment and at the 1-month follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects presenting with tattoos approximately 2 ½" x 6" or 3" x 5" or smaller in size.
- •Fitzpatrick skin type I - III
- •Women of childbearing potential using an accepted form of contraception at least 3 months prior to enrollment and during the study period (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence)
- •Subjects who provide written informed consent
- •Subjects who agree to all treatment guidelines and follow-up visits
排除标准
- •Subjects younger than 18 years of age
- •Subjects with traumatic tattoos
- •As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in the study
- •Subjects who are pregnant or breastfeeding
- •Subjects who are tan
- •As per the investigator's discretion, subjects with a history of keloid scarring or abnormal wound healing
- •Subjects who have used oral retinoids (isotretinoin or acitretin) within 12 months of study entry
- •Subjects currently participating or planning to participate in any other clinical trial specifically designed to treat tattoos during the course of this study and for the duration of their participation in the study
- •Subjects who refuse to sign this informed consent form and/or refuse to comply with all study requirements.
结局指标
主要结局
Number of passes with Describe patch
时间窗: 5 minutes
Number of passes with Describe patch compared to laser only
次要结局
- Safety assessment: Overall rate and severity of all reported adverse events(immediate post treatment, 1-month post tx)