Clinical Study to Evaluate the Performance of the PicoWayTM 1064 nm/ 785 nm/ 532nm Picosecond Laser for Tattoo Removal
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Global percentage of tattoo clearance
研究概览
简要总结
This is an open-label, multi-center study. Subjects in this study will receive up to eight (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWayTM device using the 1064 nm/ 785±20 nm/ 532 nm handpiece according to the study protocol (tattoo colors). Subjects will return for one follow-up (FU) visit at the clinic at 8 weeks following the last treatment.
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic
详细描述
This study is a prospective clinical study to demonstrate the safety and efficacy of the PicoWayTM device for tattoo removal.
Up to a total of 60 healthy candidates who are seeking tattoo removal clearance treatment from participating investigators will be enrolled at up to 3 participating study sites. Subjects will receive up to eight (8) PicoWayTM treatments at 11±5 (6-16) week's intervals. Prior to each consecutive treatment, the investigator will decide, based on degree of clearance assessment, should the subject undergo additional treatment or to be forwarded to the 8 weeks Follow-Up visit with no more treatments. Topical anesthetic (ointment) or intradermal injected solution may be used prior to treatment.
Each subject will be followed at one post treatment visit that will be conducted at:
• Eight weeks post last treatment - 8wk FU.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female and male subjects between 18 to 70 years of age
- •Fitzpatrick skin type I-VI
- •Have unwanted decorative (non-cosmetic) tattoo(s) and willing to undergo laser treatments to remove them
- •Have at least one of the following colors in the tattoo: black, green and\ or blue.
- •Willing to receive the proposed PicoWayTM treatments and comply with all study (protocol) requirements
- •Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked)
- •For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence)
- •Informed consent process is completed and subject consent is signed
排除标准
- •Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
- •Hypersensitivity to light exposure
- •Active sun tan
- •Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
- •Have a history of squamous cell carcinoma or melanoma
- •History of keloid scarring, abnormal wound healing and / or prone to bruising
- •Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment, e.g., lack of noticeable skin flaking, skin peeling and skin surface roughness.
- •History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
- •Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine
- •As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
结局指标
主要结局
Global percentage of tattoo clearance
时间窗: 8 weeks post final treatment
Global percentage of tattoo clearance as assessed by blinded evaluators based on comparing pre and post treatment photos.
次要结局
- Rate of tattoo clearance(8 weeks post final treatment)
- Adverse event reporting(Through study completion, average of 1 year)