Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Improvement in acne scarring.
研究概览
简要总结
Fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair skinned individuals. This study aims to test the efficacy and safety in darker skin types. Patients are randomized to either the 10mJ 40mJ dosages and receive a total of five treatments at 17% one month apart. Improvement is judged by a dermatologist as 0-25%, 25-50%, 50-75% or 75-100%. Side effects such as pigmentary abnormalities and pain are also evaluated.
详细描述
Background: Ablative resurfacing lasers are effective for treatment of acne scars, but they have a high risk of complications. Fractional lasers have less severe side effects but more moderate efficacy than ablative devices. Studies were performed in individuals with Fitzpatrick skin type I to VI.
Objective
To determine the efficacy and safety of an erbium 1,550-nm fractional laser in the treatment of facial acne scars in Fitzpatrick skin types IV to VI.
Methods: We conducted a prospective, single-blind, randomized trial in patients with acne scars (n=15), skin type IV to VI, with a 1,550-nm erbium fractionated laser. Patients were divided into two groups; one was treated with 10 mJ and the other with 40 mJ. Five monthly laser sessions were performed. A patient questionnaire was distributed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female voluntary patients between the ages of 18 and 59 with Fitzpatrick skin type IV-VI as verified by one of the investigators
- •Patients with clinical diagnosis of ice pick, rolling, or boxcar type ane scarring
- •Patients able to follow instructions
- •If patient has a history of cold sores (herpes labialis) they must be willing to take prophylactic valtrex
- •Written informed consent from the patients (Appendix II)
排除标准
- •Children (less than 18 years old)
- •Pregnant or lactating women
- •Personal history of keloids or hypertrophic scarring
- •Active acne requiring topical or oral therapy
- •Accutane or other oral retinoid in past year
- •Patients with a known allergy to lidocaine
- •Allergy to valacyclovir in a patient that needs prophylaxis
- •Patients with an unstable or non controlled underlying medical problem
- •Patients who are not able to follow instructions
- •Patients who have participated in a study within the 3 months prior to study entry
- •Patients who refuse to give written informed consent
- •Patients with a history of a pigmentary abnormality
结局指标
主要结局
Improvement in acne scarring.
时间窗: 6 months
Blinded evaluators will score improvement of acne via photographs using a quartile grading scale (0 = no improvement, 1 = minor improvement \[1-25%\], 2 =moderate improvement \[26-50%\], 3 =marked improvement \[51-75%\], 4 = very significant improvement \[76-100%\]).
次要结局
- Dyspigmentation(6 months)
- Pain with treatment(5 months)
研究者
David M. Ozog
Senior Staff
Henry Ford Health System