Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté
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 in overall lifting and tightening of skin
研究概览
简要总结
Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.
详细描述
This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.
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
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, aged 35 to 60 years.
- •Subject in good health.
- •Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
- •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.
- •Scarring in areas to be treated.
- •Tattoos in the areas to be treated.
- •Patients with ports or defibrillators.
- •Breast size >400cc each as measured by water displacement method.
- •History of breast reduction surgery.
- •Any open wounds or lesions in the area.
- •Active and severe inflammatory acne in the region to be treated.
- •Patients who have a history with keloid formation or hypertropic scarring
研究组 & 干预措施
Ultherapy™ treatment on the décolleté
All enrolled subjects will receive the study treatment.
干预措施: Ulthera® System (Device)
结局指标
主要结局
Improvement in overall lifting and tightening of skin
时间窗: 90 days post-treatment
Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline.
次要结局
- Skin Laxity of the Décolleté(90 and 180 days post-treatment)
- Bilateral chest measurements(90 and 180 days post-treatment)
- Overall aesthetic improvement(90 and 180 days post-treatment)
- Patient satisfaction(90 and 180 days post-treatment)