Evaluation of the Ulthera® System for Obtaining a Reduction of Wrinkles Around the Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes
研究概览
简要总结
The purpose of this prospective, multi-center, single treatment study is to evaluate the clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of the skin.
详细描述
The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for non-invasive treatment to reduce wrinkles around the eyes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 30 to 65 years.
- •Subject in good health.
- •Mild to moderate rhytids in the periorbital region.
- •Willingness and ability to comply with protocol requirements and return for follow-up visits.
- •Not pregnant.
- •Provide written informed consent and HIPAA authorization.
排除标准
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Severe solar elastosis.
- •Excessive subcutaneous fat in the face.
- •Deep wrinkles, numerous lines, with or without redundant skin in the area to be treated.
- •Excessive hooding, with or without redundant skin, in the areas to be treated.
- •Significant scarring in areas to be treated.
- •Significant open facial wounds or lesions.
- •Severe or cystic acne on the face.
- •Presence of a metal stent or implant in the facial area to be treated.
研究组 & 干预措施
Ulthera System Treatment
Ulthera treatment to the upper face.
干预措施: Ulthera® System treatment (Device)
结局指标
主要结局
Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes
时间窗: 90 days post-treatment
Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.
次要结局
- Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment(90 days post-treatment)
- Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment(60 days post-treatment)
- Patient Satisfaction Questionnaire at 180 Days Post-treatment(180 days post-treatment)
- Patient Satisfaction Questionnaire 90 Days Post-treatment(90 days post-treatment)
- Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment(180 days post-treatment)