Clinical Comparison of the Thermage CPT™ System's Framed and Pattern Tips for Treatment of Facial and Neck Laxity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement in Laxity
研究概览
简要总结
The purpose of this study to evaluate treatment with the Thermage CPT system for facial and neck laxity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25 - 65 years of age
- •Moderate facial and neck laxity
- •Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments.
- •Subject must understand the research nature of this study and sign an Institutional Review Board (IRB)-approved informed consent prior to the performance of any study specific procedure or assessment.
- •Subject agrees not to undergo excluded procedures on the face and neck for the duration of study.
排除标准
- •Subject is pregnant or breast feeding, or trying to become pregnant for three months prior to or during the study.
- •Pacemaker, internal defibrillator, or other implanted electronic device
- •Subject has an active localized infection in the treatment area(s) or an uncontrolled systemic infection.
- •Subject has had prior cosmetic procedures on the treatment area(s) within six months of the baseline visit.
研究组 & 干预措施
Framed Tip
Treatment with Thermage CPT Framed Tip
干预措施: Thermage CPT (Device)
Pattern Tip
Treatment with the Thermage CPT Pattern Tip
干预措施: Thermage CPT (Device)
Pattern Tip Group 2
Treatment with the Thermage CPT Pattern tip
干预措施: Thermage CPT (Device)
Total Tip
Treatment with the Thermage CPT Total tip
干预措施: Thermage CPT (Device)
Framed and Patterned Tip
Split face treatment with the Thermage CPT Framed and Patterned tips
干预措施: Thermage CPT (Device)
Total and Patterned Tip
Split face treatment with the Thermage CPT Total and Patterned tips
干预措施: Thermage CPT (Device)
结局指标
主要结局
Improvement in Laxity
时间窗: 6 months
Improvement in facial and neck laxity 6 months following treatment as assessed by Study Investigator using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement.
次要结局
- Improvement in Skin Laxity (Subject Self-assessed)(6 months)
- Subject Satisfaction With Treatment Results(6 months)