Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck Following Sculptra® Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.
研究概览
简要总结
This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.
详细描述
This study is a prospective,single-center, randomized clinical trial. Up to thirty (30) subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up to 10 subjects per group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 35 to 60 years.
- •Subject in good health.
- •Skin laxity in the lower face and neck.
- •Grade 1 and 2 on the Knize Scale
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 face and neck.
- •Excessive skin laxity on the face and neck.
- •No scarring in areas to be treated.
- •Any open facial wounds or lesions.
- •Acne on the face.
- •Patients who have a history with keloid formation or hypertropic scarring
- •Patients who have a hypersensitivity to injectable poly-L-lactic acid
- •Presence of a metal stent or implant in the facial area to be treated.
研究组 & 干预措施
Group A
Subjects will receive Ulthera® System alone.
干预措施: Ulthera® System (Device)
Group B
Sculptra® only
干预措施: Sculptra® (Drug)
Group C
Sculptra® treatment followed by Ultherapy™ treatment
干预措施: Sculptra® treatment followed by Ultherapy™ treatment (Other)
结局指标
主要结局
Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.
时间窗: 90 days post-treatment
Three masked assessors reviewed pre- and 90 days post-treatment photos from 29 subjects who returned for their 90-day follow-up visit, assessing for improvement in skin laxity at 90 days post-treatment compared to baseline, i.e., lifted and tightened skin in the areas treated with the assigned study treatment based on the assigned study arm.
次要结局
- Overall Aesthetic Improvement at 180 Days Post-treatment(180 days post-treatment)
- Subject Satisfaction at 180 Days Post-treatment(180 days post-treatment)
- Overall Aesthetic Improvement at 90 Days Post-treatment(90 days post-treatment.)
- Subject Satisfaction at 90 Days Post-treatment(90 days post-treatment.)