NCT02458976Unknown不适用
Pulsed-dye Laser Treatment Prior to Surgical Excision
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Scar appearance
研究概览
简要总结
This prospective pilot study will investigate whether use of a pulsed dye laser (PDL) prior to surgical excision can improve the appearance and symptoms of scars. The primary outcome measurement for the study is the quality of the scar in areas pre-treated with PDL vs. control (cryogen spray only). For this study, subjects who are scheduled for a dermatologic surgical excision will have half of the surgical area pre-treated with PDL and the other half pre-treated with cryogen spray.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Subjects with ages between 18 and 65 years, who are scheduled for a dermatologic surgical excision
- •Subjects requiring surgical excisions for any condition
- •Subjects with any Fitzpatrick skin type
- •Willingness to participate in the study
- •Willingness to receive experimental treatment
- •Informed consent agreement signed by the subject
- •Willingness to follow the follow-up schedule
- •Willingness to not use any other scar treatments during the study period (i.e scar massage, over-the-counter silicone pads, intralesional steroid of 5-fluorouracil injections, laser treatments)
排除标准
- •Pregnancy
- •Prior scar in area to be treated
- •Known photoallergy to visible light (i.e polymorphous light eruption)
- •Subject is unable to comply with treatment or follow-up visits
- •Subject with a history of being on photosensitive medications for the past 3 months (thiazides [used to treat high blood pressure], tetracyclines, fluoroquinolones griseofulvin or sulfonamides [used to treat infections], sulfonylureas [used to treat diabetes], calcium channel blockers [used to treat hypertension], phenothiazines [used to treat serious emotional problems]).
- •Known autoimmune disease (some autoimmune diseases can lead to sensitivity to light, such as lupus erythematosus)
- •Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device
结局指标
主要结局
Scar appearance
时间窗: 1 month
次要结局
未报告次要终点
研究者
Richard Rox Anderson, MD
Professor of Dermatology
Massachusetts General Hospital
研究点 (2)
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