Study for the RevLite Laser System for Facial Solar Lentigines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale
研究概览
简要总结
The purpose of this study is to evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines
详细描述
Prospective facial study using the revlite laser to treat pigmentation caused by sun damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a healthy male or female between 18 and 60 years old.
- •Is Fitzpatrick Skin types I-III
- •Is willing to consent 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.
- •Has clinically determined mild to severe facial mottled pigmentation (solar lentigines) on the face.
排除标准
- •Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- •Is hypersensitive to light exposure OR takes photo sensitized medication.
- •Has active or localized systemic infections.
- •Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
- •Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- •Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
- •Has used Accutane within 6 months prior to enrollment.
- •Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- •Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- •Has a history of keloids.
- •Has evidence of compromised wound healing.
- •Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
- •Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
研究组 & 干预措施
Revlite Laser System- Single Wavelength
Revlite Laser System- 1064nm wavelength will be used on half of the face.
干预措施: Revlite Laser System (Device)
Revlite Laser System- Dual Wavelength
Revlite Laser System- treatment will consist of 1064 nm and 532 nm wavelengths on half of the face.
干预措施: Revlite Laser System (Device)
结局指标
主要结局
Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale
时间窗: 1 month post last treatment
Photos taken at baseline will be compared to photos taken 1 month post last treatment to assess the level of improvement using the Global Aesthetic Improvement Scale. This evaluation is blinded. This scale ranges from -1 to 3, where -1 is worsened, 0 is no change, 1 is improved, 2 is much improved, and 3 is very much improved.
次要结局
- Physician Satisfaction Questionnaire(1 month post last treatment)