Fractional Resurfacing Device for Treatment of Acne Scarring
2013年12月13日 更新者：Christopher Zachary、University of California, Irvine
Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring
The purpose of this research study is to evaluate the safety and effectiveness of a new investigational laser device for treatment of acne scarring, for improvement in the appearance of surface texture and topography (recessed or uneven surfaces).
研究概览
详细说明
Thirty subjects between two research locations with an acne scar severity score greater than 4 will receive up to 3 treatments with an FDA IDE and Institutional Review Board approved 10,600nm fractional carbon dioxide laser system. Improvement of acne scarring is evaluated at 1 month and 3 months post-treatment.
Post-treatment responses evaluated are immediate erythema, immediate edema, and any other immediate responses. Evaluations are conducted immediate post treatment and one week post-treatment. Key safety data include the severity scoring of post-treatment responses, as well as by photodocumentation.
The incidence of side effects such as scarring, pigmentary changes, etc. are evaluated at follow-up visits one and three months post-treatment. Key safety data include the incidence rates and severity scoring of side effects, as well as by photodocumentation
研究类型
介入性
注册 (实际的)
15
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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California
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Irvine、California、美国、92697
- UC Irvine Dermatology Clinical Research Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Have Fitzpatrick skin type I-V. (Type I is blonde/red hair with freckles and Type V are Hispanics and lighter African Americans.)
- Are male or female.
- Are between 18 and 75 years of age.
- Have moderate to severe acne scarring. Acne scarring will be assessed with the Acne Scar Severity Scale. Subjects will be eligible for treatment if the area to be treated is scored as having an Acne Scar Severity Score > 4 according to the Acne Scar Severity Scale (0-9).
- Are able to read, understand, and sign the Informed Consent.
- Are willing and able to comply with all follow-up requirements for a minimum of 8 months.
Exclusion Criteria:
- Have had active localized or systemic infections within 6 months of enrollment
- Have compromised ability for wound healing, such as: malnutrition, oral steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid formation (raised and thickened scars), atrophic dermatitis (extreme skin irritation or itchiness) or immunologic abnormalities such as vitiligo (white patches of skin due to loss of pigment)
- Have immunocompromised status (inability to resist infection, etc.)
- Have been treated with lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 6 months of enrollment
- Have taken Accutane within 12 months of enrollment
- Are allergic to lidocaine (skin numbing agent)
- Are allergic to Valtrex (an anti-viral medication)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Fractional carbon dioxide laser system
Thirty total healthy subjects from two research centers with skin type I-IV of moderate to severe acne scarring received treatment with the 10,600 nm fractional carbon dioxide laser system.
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1-3 laser treatments using 20-100 millijoules (mJ) with 100-400 microscopic treatment zones (MTZ)/cm2 per pass and total density of 600-1200 MTZ/cm2
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Improvement of Acne Scarring
大体时间：Baseline, 1 month and 3 months post-treatment
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Subject assessment of the percent improvement of acne scarring compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
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Baseline, 1 month and 3 months post-treatment
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Average Improvement in Surface Texture
大体时间：Baseline, 1 month and 3 months post-treatment
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Subject assessment of the percent improvement of surface texture compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
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Baseline, 1 month and 3 months post-treatment
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Degree of Atrophy
大体时间：Baseline, 1 month and 3 months post-treatment
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Subject assessment of the percent improvement in extent of atrophy compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
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Baseline, 1 month and 3 months post-treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain Tolerance
大体时间：At treatment visit (up to 3 visits)
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The average pain score reported over all three treatments was 5.67, corresponding to "moderate" pain based on a 10-point scale.
The pain score is recorded on a 10-point scale, with 0 being "no pain" and 10 being "worst pain imaginable."
All subjects reported that any discomfort associated with the procedure was only during active intervention and resolved immediately post-procedure.
Increased pain scores correlated with increased density, but not increased energy.
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At treatment visit (up to 3 visits)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Christopher B Zachary, MBBS, FRCP、University of California, Irvine
- 首席研究员：Brian D Zelickson, MD、Department of Dermatology, University of Minnesota, Minneapolis, Minnesota
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年3月1日
初级完成 (实际的)
2008年7月1日
研究完成 (实际的)
2008年7月1日
研究注册日期
首次提交
2007年12月26日
首先提交符合 QC 标准的
2007年12月26日
首次发布 (估计)
2008年1月3日
研究记录更新
最后更新发布 (估计)
2014年1月15日
上次提交的符合 QC 标准的更新
2013年12月13日
最后验证
2013年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.