Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity in Patients With Fitzpatrick Skin Phototypes 3 Through 6
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in Overall Lifting and Tightening of Treated Tissue
研究概览
简要总结
This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.
详细描述
The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.
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.
- •Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity.
- •Fitzpatrick skin phototypes of 3 through
- •Provide written informed consent and HIPAA authorization
排除标准
- •Pregnant or lactating.
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Severe solar elastosis.
- •Excessive subcutaneous fat on the cheek.
- •Excessive skin laxity on the lower face and neck.
- •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
干预措施: Ulthera® System treatment (Device)
结局指标
主要结局
Change in Overall Lifting and Tightening of Treated Tissue
时间窗: 90 days post treatment
The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos
次要结局
- Patient Satisfaction Questionnaire(180 days post-treatment)
- Global Aesthetic Improvement at 90 Days Post-treatment(90 Days post-treatment)
- Global Aesthetic Improvement at 180 Days Post-treatment(180 days post-treatment)
- Patient Satisfaction Questionnaire(90 Days post-treatment)