Feasibility Study: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Laxity/Crepiness and Texture of Abdominal Tissue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Improvement laxity/crepiness and texture of abdominal tissue
研究概览
简要总结
Enrolled subjects will receive one UltherapyTM treatment on the abdomen. 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 for improving laxity/crepiness and texture of abdominal tissue. Changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal thickness, 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 25 to 60 years.
- •Subject in good health.
- •Skin laxity in the abdomen
- •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.
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 abdomen.
- •Excessive skin laxity on the abdomen.
- •Significant scarring in areas to be treated.
- •Open wounds or lesions in the area to be treated.
- •Inability to understand the protocol or to give informed consent.
- •BMI equal to and greater than 30.
研究组 & 干预措施
Study treatment
All enrolled subjects will receive one Ulthera System Treatment.
干预措施: Ulthera System Treatment (Device)
结局指标
主要结局
Improvement laxity/crepiness and texture of abdominal tissue
时间窗: 90 days post-treatment
Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline
次要结局
- Overall aesthetic improvement(180 days post-treatment)