The Efficacy of Nanofractional Radiofrequency Device in Arm Rejuvenation and Tightening : a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Effects of arm rejuvenation and tightening
研究概览
简要总结
The objective of this study is to evaluate arm rejuvenation and tightening with a nanofractional radiofrequency device, Venus viva, Venus concept, Toronto Canada. We recruit 20 subjects. All 20 subjects are treated with 3 sessions, 1 month interval with a nano fractional radiofrequency device on the inner upper arm. We evaluate skin tightening using %improvement of treated surface areas and skin elasticity using Dermalab the result at 3 months after the last treatment and clinical improvements evaluated by two board certified dermatologist (using compared photos between before treatment and 3 months after the last 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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female or male subjects, at least 30-60 years old of age
- •Subject who has BMI 18.50- 25 kg/m2 (as picture criteria above)
- •Subject has clinically evident moderate skin laxity with or without wrinkle on the upper arm
- •Subject has read and signed a written informed consent form.
排除标准
- •Patient with weight loss > 15%
- •Pregnancy or Lactation
- •History of pacemaker, defibrillator
- •History of laser resurfacing, prior radiofrequency, ultrasound or focused ultrasound on treatment areas within 1 year on the treatment area
- •History of Heat sensitivity, collagen vascular disorder disease including morphea, scleroderma, heat contact urticaria
- •History of medical illness that primary investigator thinks could interfere or influence the wound healing process
- •History of abnormal scars (keloid, hypertrophic scars)
- •History of skin cancer, radiation therapy or metal implants on treatment areas
- •Active local or systemic infection on treatment areas
- •Any other conditions that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
- •Subject is unable or unwilling to comply with the study requirements.
- •Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
结局指标
主要结局
Effects of arm rejuvenation and tightening
时间窗: 12 weeks after the last treatment
Determined by changing of the treated surface area (calculated from four-fixed tattoo points on the inner arm) surface area = length x width cm2
次要结局
- Changing of skin laxity and elasticity(12 weeks after the last treatment)
- Changing of skin wrinkles and laxity using photographs of subjects' baselines and 12 weeks after the last treatment by two independent board certified dermatologists(12 weeks after the last treatment)
- evaluate perceptions of treatment with a nano-fractional radiofrequency device(12 weeks after the last treatment)