NCT01701440Unknown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
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improvement in cosmesis
研究概览
简要总结
In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and improve contour and cosmesis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria for the study are:
- •Male or female 21 to 65 years old,
- •Clinically appreciable skin laxity on the abdomen (including flank), face, neck, hips, thighs, upper arms & buttocks as determined by the study investigator,
- •For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
- •Apparently healthy,
- •Informed consent signed by the subject.
排除标准
- •The exclusion criteria for the study are:
- •History of skin hypersensitivity,
- •Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex) in the treatment area,
- •Subjects with 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,
- •Infectious diseases (such as HIV) present,
- •Are a tobacco smoker,
- •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
Improvement in cosmesis
时间窗: 1 month
Improvement in cosmesis will be assessed by scoring photographs taken before and 1 month after treatment. Circumference changes will be measured and compared
次要结局
- Improvement in cosmesis(3 months)
研究者
研究点 (2)
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