NCT04681352已完成不适用
Prospective, Evaluator-blind, Multicenter Study to Assess the Safety and Effectiveness of Treatment With the Octave System for Improving Lines and Wrinkles of the décolleté
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
- 99
- 试验地点
- 10
- 主要终点
- Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90
研究概览
简要总结
To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe fine lines, wrinkles, laxity, and crepiness of the décolleté that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention.
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.
- •Breast implants or is planning to receive breast implants during the study.
- •Inability to take pre-treatment medications due to a pre-existing condition, medication allergy, or medical issue that, at the discretion of the treating investigator, is contraindicated.
研究组 & 干预措施
Octave System
Experimental
Single treatment of décolleté tissue.
干预措施: Octave-Ultherapy treatment (Device)
结局指标
主要结局
Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90
时间窗: Day 90
Improvement in lines and wrinkles of the décolleté were determined after comparing Day 90 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 90 photographs as "improved" compared to baseline.
次要结局
- Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180(Day 180)
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs)(From Day 1 up to end of the study (Up to Day 180))
研究者
研究点 (10)
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