NCT01813786已完成不适用
Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Subject Biopsy Sampling
研究概览
简要总结
Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a healthy male or female between 18 and 85 years old
- •Has unwanted scars not including atrophic 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 biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.
- •Has Fitzpatrick skin types I to IV.
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 heavy aspirin therapy {greater than 81 mg per day}).
- •The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- •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 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 subjects has an allergy to lidocaine and epinephrine.
结局指标
主要结局
Subject Biopsy Sampling
时间窗: 3 months post last treatment
Histological examination of tissue samples will be compared between baseline and 3 months post treatment.
次要结局
- Subject Biopsy Sampling(1 month post treatment)
- Photographic evaluation as a measure of improvement.(up to 3 months post last treatment)
研究者
研究点 (1)
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