NCT05067504已完成不适用
Prospective, Evaluator-blind, Multicenter Study to Assess the Safety and Effectiveness of Treatment With the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Percentage of Treated Subjects With Eyebrow Lift at Day 90
研究概览
简要总结
This study was conducted to evaluate the effectiveness and safety of the Octave System to lift the eyebrow and improve the appearance of the face and neck.
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
盲法说明
While there was only one arm, Outcome Assessors were masked to pre- vs post-treatment images.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate eyebrow/upper-face laxity.
- •Mild to moderate fine lines, wrinkles, and laxity of the face and neck.
排除标准
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Scarring in area(s) to be treated.
- •Active implants (e.g., pacemakers or defibrillators), ports, or metallic implants in area(s) to be treated.
研究组 & 干预措施
Octave-Ultherapy treatment
Experimental
Octave-Ultherapy treatment of the brow, face, and neck.
干预措施: Octave-Ultherapy treatment (Device)
结局指标
主要结局
Percentage of Treated Subjects With Eyebrow Lift at Day 90
时间窗: Day 90
Improvement in eyebrow lift was determined by three evaluators after comparing Day 90 photographs with baseline photographs. Lift was concluded if at least two evaluators reported "eyebrow lift" in the Day 90 photographs as compared to baseline.
次要结局
- Percentage of Treated Subjects With Eyebrow Lift at Day 180(Day 180)
- Percentage of Treated Subjects With Eyebrow Lift of at Least 0.5 Millimeter (mm) at Day 90 and Day 180(Day 90 and Day 180)
- Change From Baseline in FACE-Q Satisfaction With Forehead and Eyebrows Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject(At Baseline, Day 90 and Day 180)
- Change From Baseline in FACE-Q Satisfaction With Lower Face and Jawline Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject(At Baseline, Day 90 and Day 180)
- Change From Baseline in FACE-Q Patient-Perceived Age Visual Analogue Scale (VAS) Rating at Day 90 and Day 180, as Assessed by the Subject(At Baseline, Day 90 and Day 180)
- Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Octave-Ultherapy Treatment(From first treatment on Day 1 up to the end of study on Day 180 (an average of 6 months))
研究者
研究点 (3)
Loading locations...
相似试验
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT06762340[Redacted]
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT04616833[Redacted]
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT04945941[Redacted]
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT06733259[Redacted]
已完成
不适用
Clinical Investigation (Beta) of a New Developed Prosthetic KneeAmputationNCT06748729Össur Iceland ehf11