NCT01030198终止不适用
Post-Market, Two-Arm, Single Blind, Controlled Study of the RevLite Electro-optic Q-Switched Neodymium-doped Yttrium Aluminum Garnet (EO QS Nd:YAG) Laser System for the Treatment of Scars
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis
研究概览
简要总结
The purpose of this study is to measure the effectiveness of the RevLite Laser in the treatment of both fresh surgical scars and mature/older scars.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- 是
入选标准
- •Fitzpatrick Skin Type I-VI and either a fresh surgical scar (with sutures still present [or dissolving sutures within 7 days of surgery for facial scars or within 14 days of surgery for scars on the trunk or extremities) of at least 2cm in length or an erythematous and/or hypertrophic scar of at least 2cm in length and of greater than or equal to 18 months in duration
- •Scar is easily divisible into two equal segments for the purpose of the study, or is bilateral in nature (e.g., inframammary)
排除标准
- •Pregnant, lactating, or is planning to become pregnant
- •history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- •any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical systemic therapy
- •coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
- •any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study
- •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
- •unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
- •unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits
- •Isotretinoin therapy within 6 months
- •need to be exposed to artificial tanning devices or excessive sunlight during the trial
- •prior treatment with parenteral gold therapy
- •does not agree to refrain from other laser treatment, (micro)dermabrasion or topical scar treatment creams for the duration of the study
- •Diabetes Type 1 or 2
- •Lupus, scleroderma or similar immune system disorder
- •underlying silicone or other non-absorbable filler in the area of the scar
- •phenol chemical peel or dermabrasion to the area of the scar within 3 months
- •Fitzpatrick Skin Type IV, V or VI with a known sensitivity to hydroquinone or is unwilling or unable to comply with physician/manufacturer instructions for the use of this ingredient
结局指标
主要结局
Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis
时间窗: 1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars)
The number of participants who experienced improvements in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis will be counted.
次要结局
未报告次要终点
研究者
研究点 (2)
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