Evaluation of the Efficacy and Safety of the Ulthera® System for Lifting and Tightening of the Face and Neck Following an Increased Density Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Improvement in Overall Lifting and Tightening of Skin
研究概览
简要总结
The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.
详细描述
All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre- and post-treatment photos will be taken. Subjects will be required to return for follow-up visits at 60 days, 90 days, 180 days and 1 year following treatment.
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
- 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
- •Desires lift and tightening of cheek tissue, reduction of jowling, improvement of jawline definition and/or submental skin laxity
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period
- •Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
排除标准
- •Presence of an active systemic or local skin disease that may affect wound healing
- •Severe solar elastosis
- •Excessive subcutaneous fat on the cheeks
- •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, a pacemaker, or cochlear implants
研究组 & 干预措施
Ultherapy treatment
Ulthera System Treatment
干预措施: Ulthera System Treatment (Device)
结局指标
主要结局
Improvement in Overall Lifting and Tightening of Skin
时间窗: Baseline to 90 days post treatment
Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.
次要结局
- Subjects' Assessment of Pain(During Ulthera treatment)
- Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment(Baseline to 90 days, 180 days and 1 year post-treatment)
- Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.(Baseline to 60 days, 90 days, 180 days and 1 year post-treatment)