Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser"
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Physician's Global Assessment of improvement post-final treatment
研究概览
简要总结
A single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink.
详细描述
This is a single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink. Subjects will receive up to 5 laser treatments, spaced 4 to 6 weeks apart, and will be followed at 3 months post-final treatment. Number of laser treatments required shall be based upon tattoo response to laser irradiation. The Investigator will terminate laser treatments upon 100% clearance of tattoo or after 5 treatment sessions, or in the event of an adverse effect which requires cessation of laser treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fitzpatrick Skin Type I - VI
- •Target tattoo contains only black ink, is more than 1 year old and must have been obtained from a professional tattoo parlor.
- •Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment and/or every day for the duration of the study, including the follow-up period.
排除标准
- •Target tattoo is 'home made' OR was obtained from an amateur artist.
- •Presence of double tattoo in the treatment area or presence of tribal, scarred, high-ink density, or highly colorful single tattoo.
- •Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- •History of allergic reaction to pigments following tattooing.
- •History of allergy to local anesthetics.
- •History of malignant tumors in the target area.
- •History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- •Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- •Current smoker or history of smoking within 6 months of study participation.
结局指标
主要结局
Physician's Global Assessment of improvement post-final treatment
时间窗: 3 months
Assessment of tattoo clearance by independent blinded reviewers
次要结局
- Subject's Global Assessment of improvement post-final treatment(3 months)
- Subject Satisfaction post-final treatment(3 months)
- Incidence and severity of adverse device effects(Day 0, 4 wks, 8wks, 12 wks, 16 wks, 28 wks)