Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Brachia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity
研究概览
简要总结
This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.
详细描述
This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will 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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 19 - 55 years.
- •Subject in good health.
- •Subjects who desire lift and tightening of the brachia and improvement in skin laxity.
- •Mild to moderate laxity of the upper arm.
- •Mild to moderate subcutaneous fat of the upper arm.
- •Mild crepiness of the skin of the upper arm.
- •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 upper arm.
- •Excessive skin laxity in the upper arm.
- •Significant scarring in areas to be treated.
- •Significant open wounds or lesions in the treatment areas.
- •Severe or cystic acne in the treatment areas.
研究组 & 干预措施
Ultherapy™ treatment
Each enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms
干预措施: Ulthera® System (Device)
结局指标
主要结局
Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity
时间窗: Baseline to 90 days post-treatment
Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.
次要结局
- Overall Aesthetic Improvement(Baseline to180 days post-treatment)
- Change in Dermal Thickness(Baseline to180 days post-treatment)
- Patient Satisfaction(Baseline to 180 days post-treatment)
- Quantitative Improvement in Skin Laxity(Baseline to 90 days post-treatment)
- Change in Dermal Thickness(Baseline to 90 days post-treatment)
- Overall Aesthetic Improvement(Baseline to 60 days post-treatment)
- Overall Aesthetic Improvement(Baseline to 90 days post-treatment)
- Patient Satisfaction(Baseline to 90 days post-treatment)