NCT05096247已完成不适用
Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Number of Subjects Who Noticed Improvement
研究概览
简要总结
The intended use of the RF (radiofrequency) device used in this study is to assess the efficacy of the handpiece for the treatment of facial wrinkles. If the other device (Intense Pulsed Light) laser in this study is used, the intended use will be for the treatment of benign pigmented and/or vascular lesions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A healthy male or female 18 years of age or older.
- •Agrees to be treated with the TempSure device.
- •Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
- •Understands and accepts the obligation and is logistically able to be present for all visits.
- •Is willing to comply with all requirements of the study and sign the informed consent document.
排除标准
- •Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
- •The subject has a cut, wound, or infected skin on the area to be treated.
- •The subject is on local, oral, or systemic anesthetic agents.
- •The subject has nerve insensitivity to heat in the treatment area.
- •The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
- •Exclusion Criteria for Icon Treatments Only:
- •The subject is using systemic steroids (e.g. prednisone, dexamethasone) prior to or during the course of treatment.
- •The subject has a medical condition or is receiving treatment that significantly compromise healing response.
- •The subject has a history of light-induced seizures.
- •The subject has a history of skin photosensitivity disorders.
- •The subject has a history of hypertrophic scars or keloid formation.
- •The subject has a history of radiation therapy in area to be treated.
结局指标
主要结局
Number of Subjects Who Noticed Improvement
时间窗: 12 week follow up
Subjects graded themselves on a scale ranging from "Worsened" to "Very Much Improved" at the follow up visit. The number of subjects who graded themselves as "Improved" was reported.
次要结局
未报告次要终点
研究者
研究点 (6)
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