NCT03866304Unknown不适用
A Single-center, Open-label, Uncontrolled Pilot Study to Evaluate the Safety and Efficacy of S2 - Multi-Wavelength Laser for Tattoo Removal
LigthSense Israel Ltd2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Tattoo clearing
研究概览
简要总结
Evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal
详细描述
The purpose of this investigation is to evaluate safety and efficacy of S2 multi-wavelength laser for tattoo removal.
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
- •Healthy female and male subjects between 18 to 65 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 a tattoo contains containing single or multi-color ink.
- •Willing to receive the proposed S2 laser treatments and comply with study (protocol) requirements
- •Must be able to read, understand and sign the Informed Consent Form
- •Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
- •Agree not to undergo any other procedure(s) for the tattoo removal during the study.
排除标准
- •Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
- •Pregnant or planning to become pregnant, having given birth less than 3 months prior to treatment, and/or breastfeeding
- •History of allergic reaction to pigments following tattooing.
- •History of hypersensitivity to light exposure
- •Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- •History of malignant tumors in the target area.
- •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 or during the treatment course
- •Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
- •History of keloid scarring, abnormal wound healing and / or prone bruising
- •Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
- •Suffering from coagulation disorders or taking prescription anticoagulation medications.
- •History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- •History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- •History of vitiligo, eczema, or psoriasis.
- •History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- •History of seizure disorders due to light.
- •Suffering from Histoplasmosis, hyperparathyroidism, Lymphoma, kidney disease, sarcoidosis, tuberculosis, high levels of calcium in the blood
- •Suffering from Vitamin D deficiency
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
研究组 & 干预措施
Picosecond Laser
Experimental
Treatment with investigational wavelengths of the S2 laser for tattoo removal.
干预措施: Device: S2 Picosecond laser (Device)
结局指标
主要结局
Tattoo clearing
时间窗: 8 weeks post-final treatment (up to 6 month)
Tattoo clearing as rated by blinded reviewers at 8 weeks post-final treatment (Physician's Global Assessment of Improvement). Blinded reviewer will first be asked to determine the temporal order (before and after) of each photograph pair for each treatment side and then rate the degree of tattoo clearing observed in the after photograph (compared to before photograph) using the Physician's Global Assessment scale: 4 = Very Significant Clearing (\> 75%) 3 = Significant Clearing (51 - 75%) 2 = Moderate Clearing (26 - 50%) 1 = Mild Clearing (5 - 25%) 0 = No Change (\< 5%)
次要结局
- Degree of tattoo clearing at 8 weeks post-final treatment as assessed by Subject(8 weeks post-final treatment (up to 6 month))
- Subject discomfort (pain) during treatments(During the treatments period (up to 6 month))
- Subject satisfaction Questionnaire (4-8 weeks post-final treatment)(4-8 weeks post-final treatment (up to 6 month))
- Degree of tattoo clearing as assessed by PGA(8 weeks post-final treatment (up to 6 month))
研究者
研究点 (2)
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