NCT01813747已完成不适用
Mandible and Sub-mandible Using the 1440nm Wavelength Laser and Hand Piece
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Photographic Evaluation
研究概览
简要总结
The purpose of this study is to use the 1440nm Wavelength laser along with the hand piece to provide clinical outcome data for treatment of the mandibular and submandibular areas specifically for skin tightening and laser lipolysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy non-smoking male or female subjects 18-65 years of age
- •Presents for treatment of their unwanted skin laxity and fat in the mandibular and submandibular areas for an improved aesthetic appearance and is willing to undergo laser treatment
- •Understands/accepts obligation not to receive any other procedures in the mid-face to sub-mandibular areas through 3 months follow up visit
- •Understands/accepts the obligation and is logistically able to present for all scheduled follow up visits
- •Is capable of understanding the consent form and able to provide written consent to participate in the study and any other practice consents for anesthesia and surgical procedures
- •Understands/accepts obligation to have facial photographs taken
- •Understands/accepts may be asked to consent to having a two 2mm biopsies in an inconspicuous place such as behind the ear
- •Agrees to maintain present diet and exercise program
排除标准
- •Has had any procedure in the mid-face to sub-mandibular areas in the last six months
- •Has a history of thrombophlebitis, history of coagulation disorders or using anticoagulant medications
- •Has a significant systemic illness or immunity disorder or localized condition affecting treatment area
- •Is female and pregnant, was pregnant or given birth within the last three months, is currently breast feeding, or planning a pregnancy during the course of the study
- •Has known history of allergic reactions to local anesthesia
- •Has any other medical condition, that, in the investigator's opinion would interfere with the subject's participation in the study
- •Is susceptible to light induced seizures or history of seizures
- •Has a history of keloid formation
- •Has therapies or medications which may interfere with the treatment (including medications causing photosensitivity
- •Has a BMI above 30
结局指标
主要结局
Photographic Evaluation
时间窗: 3 months post last treatment
Photos will be evaluated by the investigator comparing time baseline and 3 month photos using the global aesthetic improvement scale
次要结局
- Number of participants with adverse events(up to 3 months post last treatment)
- Photographic Evaluation(1 week post treatment)
研究者
研究点 (2)
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