Evaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Severity Change in Acne Scarring
研究概览
简要总结
The purpose of this study is to assess treatment of facial acne scars using the 755nm Alexandrite Laser with lens arrays.
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
- •Is a healthy male or female between 18 and 65 years old
- •Has unwanted acne scars, excluding ice pick scars (Deep atrophic scars that resemble poked holes), 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.
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 subject has an allergy to lidocaine and epinephrine.
研究组 & 干预措施
755nm Alexandrite laser with lens array
干预措施: 755nm Alexandrite laser with lens array (Device)
结局指标
主要结局
Severity Change in Acne Scarring
时间窗: Baseline and 3 months post treatment
The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).
Severity Change in Acne Scarring
时间窗: Baseline and 1 month post treatment
The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).
次要结局
- Subject Satisfaction Questionnaire(3 months post treatment)
- Investigator Satisfaction Questionnaire(3 months post treatment)