Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Overall Improvement of Acne Scarring
研究概览
简要总结
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).
详细描述
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Overall Improvement of Acne Scarring
时间窗: Baseline, 1 month and 3 months post-treatment
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).
Average Improvement in Surface Texture
时间窗: Baseline, 1 month and 3 months post-treatment
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).
Degree of Atrophy
时间窗: Baseline, 1 month and 3 months post-treatment
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).
次要结局
- Pain Tolerance(At treatment visit (up to 3 visits))
研究者
Christopher Zachary
Clinical Professor
University of California, Irvine