RF Pixel With Micro-Plasma Technology: Fractional Ablative Radiofrequency for the Treatment of Acne Scars and RF Pixel With Micro-Plasma Technology: Fractional Ablative Radiofrequency for the Treatment of Acne Scars and
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Improvement in the appearance of wrinkles and acne scars
研究概览
简要总结
To assess the safety and efficacy of the Pixel RF (fractional radio frequency) module in the treatment of acne scars and wrinkles.
详细描述
The study design will be a prospective open label study. Up to 20 subjects of both genders with acne scars and/or wrinkles in the face will be recruited. The subjects will be treated once on clean acne scarred skin and three times on the the wrinkled skin with the Pixel RF handpiece. Each treatment duration will be approximately 30 minutes. The initial power and number of passes parameters shall be set according to the clinical indication and skin type of the subject treated (as well as the results of test sites).
Clinical improvement will be assessed by the investigator physician from the visual appearance of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement. Adverse side effects will be scored by clinical evaluation of erythema, edema, and burns. Real-time assessments will be made as well by the investigators. Treatment and results will be documented in a Case Report Form and follow-up sessions (1, 5 days after the treatment and 1 month and 3 months after the treatment).
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
- •Subjects meeting the following inclusion criteria may participate:
- •Male or female subject 18-60 years of age.
- •Clinically documented rolling and boxcar acne scars and/or wrinkles score of 2 or 3 per the Rao-Goldman scale (see section 6.5.1 for wrinkle classification).
- •Limitation to acne scared and wrinkles area: face.
- •Patients must commit to all follow-up visits.
排除标准
- •Subjects meeting any of the following criteria will be excluded from participation:
- •Bacterial or viral infection
- •Impaired immune system
- •Isotretinoin (Accutane, Amnesteem, Claravis, and Sotret) in the past 6 months
- •Scleroderma
- •Extensive radiation therapy
- •Burns in the treatment area
- •Poor healing in the treatment area
- •Metal implants near the treatment area
- •Implantable pacemaker or automatic defibrillator/cardioverter (AICD)
- •Ablative/non-ablative cosmetic intervention (deep peeling) in the past 3 months in the areas to be treated
- •Active cancer
- •Active collagen or vascular disease
- •Pregnancy or IVF procedure
结局指标
主要结局
Improvement in the appearance of wrinkles and acne scars
时间窗: 3 months
Visual assessment of the improvement in the appearance of wrinkles and acne scars after treatment with fractionated RF.
次要结局
未报告次要终点