NCT01279226已完成不适用
Radiofrequency Magnetic Induction Device for Use in Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improved cosmesis
研究概览
简要总结
The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device intended to be used to improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female at least 21 years old,
- •Apparently healthy,
- •Informed consent signed by the subject.
排除标准
- •Tobacco smokers,
- •History of skin hypersensitivity,
- •Current skin disorder or infection (e.g., herpes simplex),
- •Prior cosmetic treatments to the face (e.g. Botox) or facial fillers (e.g. Restylane),
- •Subjects with a pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
- •Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
- •The current or recent use (within the past 12 months) of isotretinoin,
- •Pregnancy or breast feeding,
- •Insulin dependent diabetic subjects,
- •Oxygen dependent subjects,
- •Subjects with severe chronic illness, scleroderma, or lupus,
- •Subjects with open sores or scars in the treatment region, or
- •Subjects with ischemia in the treatment region.
结局指标
主要结局
Improved cosmesis
时间窗: 2-6 timepoints from 4 days to 6 months
Photographs of subjects before and after treatment will be scored and compared. Histology of skin samples may be used to assess deleterious events and elucidate the operative mechanism.
次要结局
未报告次要终点
研究者
研究点 (2)
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