NCT02146820已完成不适用
LASER TREATMENT OF BENIGN PIGMENTED LESIONS WITH A DUAL WAVELENGTH PICOSECOND LASER
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Global percentage of pigment clearance
研究概览
简要总结
The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of benign pigmented lesions.
详细描述
The Investigational device is a dual wavelength laser system developed for treatment of pigmented lesions and for tattoo removal. The base unit is a GentleMax system modified to emit light at wavelengths of 532 and 1064 nm and deliver pulse energy up to 400mJ, and pulse duration of 700 ps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has Fitzpatrick skin type I-VI
- •Has unwanted benign pigmented lesions including but not limited to solar lentigines, freckles, café au lait, melasma, New of Ota, Nevus of Ito, and hyperpigmentation, and wishes to undergo laser treatments to remove them
- •Is willing to sign an informed consent form to participate in the study
- •Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits
排除标准
- •Is hypersensitive to light exposure
- •Has an active sun tan
- •Has active localized or systemic infection
- •Is taking medication(s) for which sunlight is a contraindication
- •Has a history of squamous cell carcinoma or melanoma
- •Has a history of keloid scarring
- •Has used 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.
- •Has had a laser procedure, a peel or has used lightening creams in the area to be treated with in the past six months
- •Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications
- •Is female and pregnant is currently breast feeding or planning a pregnancy during the study period
- •Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine
- •Subjects with pigmented lesions that are considered not acceptable by the study doctor or any condition that, in the study doctor's opinion, would make it unsafe to treat.
结局指标
主要结局
Global percentage of pigment clearance
时间窗: 3 months post the final treatment
Global percentage of pigment clearance evaluated by blinded observers using post treatment photographs compared to baseline photographs.
次要结局
- Number of Participants with Adverse Events(3 months)
研究者
研究点 (3)
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