NCT01221922已完成不适用
A Study of the RevLite Q-Switched Neodymium: Yttrium-Aluminum-Garnet (Nd:YAG) Laser for the Treatment of Acne Scars in Fitzpatrick Skin Types III-VI
ConBio, a Cynosure Company1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Global Acne Scarring Classification
研究概览
简要总结
The purpose of this study is to evaluate the RevLite Q-Switched Neodymium: Yttrium-Aluminum-Garnet (Nd:YAG) Laser in the treatment of acne scars in darker skin types (Fitzpatrick Skin Types III, IV, V and VI).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older with Fitzpatrick Skin Type III, IV, V or VI
- •Evidence of atrophic scarring
排除标准
- •Pregnancy, lactating or planning to become pregnant during the study
- •History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis
- •Any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy
- •Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate
- •Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days prior to entering the study
- •Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
- •Subject may be unreliable for the study. This includes subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits
- •Use of oral or topical isotretinoin therapy within 6 months prior to enrollment. With the exception of isotretinoin, subjects will be allowed to continue their topical or oral acne medications during the trial
- •Need to be exposed to artificial tanning devices or excessive sunlight during the trial
- •Prior treatment with parenteral gold therapy
- •Diabetes Type I or II, Lupus, Scleroderma or a similar immune system disorder
- •Subject does not agree to refrain from any other type of facial skin resurfacing (e.g., microdermabrasion, laser or IPL treatment, chemical peel) or injected filler/other substances (e.g., Restylane, Botox) that might affect the treatment area for the duration of the study
- •Underlying silicone or other nonabsorbable fillers in the treatment area or has had filler (e.g., collagen, fat) injections within the past 3 months
- •History of keloidal scarring or nodulocystic acne
- •Phenol or chemical peel or dermabrasion to the the treatment area within the past 6 months
结局指标
主要结局
Global Acne Scarring Classification
时间窗: 3 Months post final treatment
次要结局
- Subject Satisfaction(3 Months post final treatment)
研究者
研究点 (1)
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