NCT02103816已完成不适用
The Smartlipo Triplex 1440nm Wavelength Laser and the Sidelaze 800 Hand Piece for the Treatment of Facial Acne Scars
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale
研究概览
简要总结
The purpose of this study to evaluate the SmartLipo Triplex laser system along with the SideLaze800 hand piece in the treatment of Acne Scars.
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
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
- •A healthy male or female between 18 and 65 years old
- •Has unwanted facial acne scars and wishes to undergo laser treatments.
- •Is willing to consent to participate in the study.
- •Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending follow up visits.
排除标准
- •The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- •The subject is hypersensitive to light exposure OR takes photo sensitized medication.
- •The subject has active or localized systemic infections.
- •The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin) {greater than 81 mg per day}).
- •The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within the planned treatment area 3 months prior to entering this study.
- •The subject has used Accutane within 6 months prior to enrollment.
- •The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- •The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- •The subject has a history of keloids.
- •The subject has evidence of compromised wound healing.
- •The subject has a history of squamous cell carcinoma or melanoma.
- •The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- •The subject has an allergy to lidocaine and epinephrine.
- •The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
结局指标
主要结局
Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale
时间窗: 3 months post treatment
This assesses the level of improvement of acne scarring using the Global Aesthetic Improvement Scale. It is done through using photographic evaluation, comparing the baseline photograph to a photograph taken 3 months post the last treatment. The options for the acne scarring improvement are very much improved, much improved, improved, no change, or worse. The photographic evaluator decides this improvement based off of scar appearance differences amongst the photographs.
次要结局
- Subject Satisfaction Questionnaire(3 months post treatment)
- Investigator Satisfaction Questionnaire(3 months post treatment)
研究者
研究点 (2)
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