Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Elbow Tissue - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Overall improvement of skin laxity in the areas treated
研究概览
简要总结
Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
详细描述
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve skin laxity above the elbows. Masked assessment of pre- and post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.
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
- •Male or female, age 21 to 65 years.
- •Subject in good health.
- •Mild to moderate skin laxity on the elbows.
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up 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.
- •Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control
排除标准
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Excessive subcutaneous fat around the elbows.
- •Excessive skin laxity around the elbows.
- •Significant scarring in areas to be treated.
- •Significant open wounds or lesions in the area to be treated
结局指标
主要结局
Overall improvement of skin laxity in the areas treated
时间窗: 90 days post-treatment
Determined by masked assessment analysis of photographs at 90 days post treatment compared to baseline.
次要结局
- Aesthetic improvement(90 and 180 days post-treatment)