NCT00955461已完成不适用
Post-Market, Randomized, Single Blind, Split-Faced Comparison of the RevLite Nd:YAG Laser System Versus a Non-Ablative, Mid Infra-red, Fractionated Type Laser System for Skin Rejuvenation
ConBio, a Cynosure Company1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2009年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Assessment of the percentage of overall, cumulative improvement from Baseline in the appearance of wrinkles, skin tone and/or texture, pigmentation and acne scars
研究概览
简要总结
The purpose of this study is to compare the results of treatment between the side of the face treated with the RevLite Laser and the side of the face treated with a fractionated laser system.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fitzpatrick Skin Type I-VI and Wrinkle Class I
- •Between the ages of 25-65
- •Evidence of bilateral dyschromia
排除标准
- •Pregnant, lactating, or is planning to become pregnant
- •history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- •any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical or systemic therapy
- •coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
- •any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study
- •currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days
- •unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
- •unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits
- •Accutane within 6 months
- •need to be exposed to artificial tanning devices or excessive sunlight during the trial
- •prior treatment with parenteral gold therapy
- •Diabetes Type 1 or 2
- •does not agree to refrain from any other type of facial skin resurfacing (e.g., microdermabrasion, laser or IPL treatment, chemical peel) or injected fillers/other substances (e.g., Restylane, Botox) that might affect the treatment area for the duration of the study
- •artificial tanning within 1 month
- •(micro)dermabrasion within 3 months
- •other laser or IPL to the face within 6 months
- •chemical peel within 1 month
- •injectable fillers within 3 months
- •topical retinoids within 3 months
- •over-the-counter anti-aging products (e.g., those containing peptides, hyaluronic acid, or agents specifically advertised as having anti-aging or age-inhibiting properties) within 1 month
- •history of keloids or hypertrophic scarring
- •evidence of compromised wound healing
- •history of cold sores, chickenpox or shingles and unwilling to take a prophylactic course of Valtrex/acyclovir
- •allergy to acyclovir
结局指标
主要结局
Assessment of the percentage of overall, cumulative improvement from Baseline in the appearance of wrinkles, skin tone and/or texture, pigmentation and acne scars
时间窗: 3 and 6 months post final treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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