Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ulthera, Inc
- 入组人数
- 25
- 主要终点
- Number of Participants With Lift in Brow Region at Day 90
研究概览
简要总结
To evaluate the effect of the Ulthera® system for facial laxity and sagging skin
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
- 39 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to sign a written consent form
- •Willing to have of facial skin laxity and wrinkles assessed by clinician
- •Male or female, aged 39 to 65 years.
- •Willingness to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- •Willingness to cooperate with photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
- •Must understand the ultrasound device (Ulthera) treatment may have no therapeutic effect.
- •Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
排除标准
- •Open wounds or lesions in the area(s) to be treated.
- •Severe or cystic acne on the area(s) to be treated.
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.).
- •Subcutaneous fillers
- •Keloid scar
- •Patients with anticoagulant treatment plan.
- •Children, pregnant women, breastfeeding women.
- •Patients with the following disease conditions: bleeding disorders or coagulation disorder that may affect wound healing, active localized disease, herpes simplex, autoimmune diseases, diabetes, epilepsy bell-type paralysis (temporary facial palsy)
研究组 & 干预措施
Microfocused ultrasound with visualization
干预措施: Microfocused ultrasound with visualization (Device)
结局指标
主要结局
Number of Participants With Lift in Brow Region at Day 90
时间窗: Baseline, Day 90
Lift improvement as measured by quantitative analysis was considered minimum 0.5 millimeter (mm) Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points along the natural outline of each participant's brow. Brow height was calculated using the sum and average of the five calculations in each brow area.
Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90
时间窗: Baseline, Day 90
Lift improvement as measured by quantitative analysis was considered greater than or equal to (\>=) 20.0 square millimeter (mm\^2) of the submental area Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points on the neck. Area was calculated in between each of the 5 points and then sum of the five calculations was the total area of the region of interest.
次要结局
- Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90(Day 90)
- Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180(Baseline, Day 180)
- Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90(Baseline, Day 90)
- Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90(Baseline, Day 90)
- Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180(Baseline, Day 180)