NCT00747422已完成不适用
Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Periorbital Wrinkles
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- reduction of periorbital wrinkles
研究概览
简要总结
The purpose of this study is to look at how safe and effective the Ulthera ultrasound system is at reducing the appearance of wrinkles when used with subjects who have wrinkles around the eyes.
详细描述
The purpose of this prospective, multi-center, single treatment, clinical trial is to evaluate the effectiveness and safety of the Ulthera™ System for the non-invasive treatment of periorbital wrinkles and rhytids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 40 to 70 years
- •Subject in good health
- •Desire improvement in periorbital wrinkles
- •Subject provides informed consent and agrees to attend follow-up visits
- •Subject signs a HIPPA authorization
排除标准
- •Pregnant or lactating
- •Has an active systemic or local skin disease that may alter wound healing
- •Has significant scarring in test areas
- •Has significant open facial wounds or lesions
- •Has severe or cystic acne on the face
- •Has a metal stent or implant in the face area
- •Is a current smoker or has a history of smoking in last 10 years
研究组 & 干预措施
I
Experimental
干预措施: Ulthera™ System (Device)
结局指标
主要结局
reduction of periorbital wrinkles
时间窗: 3 and 6 months
次要结局
未报告次要终点
研究者
研究点 (8)
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