Pilot Study on the Use of the Matrix Radiofrequency for Treatment of Port Wine Stain Birthmarks
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Medical Tool
研究概览
简要总结
Port wine stain, also called nevus flammeus, is a congenital, cutaneous vascular malformation involving post-capillary venules which produces a light pink to red to dark-red-violet discoloration of the skin. It is estimated that Port wine stain occurs in 3 children per 1,000 live births. Approximately 900,000 individuals in the United States and twenty million people worldwide have Port wine stain birthmarks .
详细描述
The purpose of this research study is to improve port wine stain treatment after Matrix Radiofrequency device treatment. The Matrix Radiofrequency device energy generates fractional deep dermal heating in the region of the electrode matrix to induce skin injury, thus eliciting a wound healing response. Less affected tissue surrounding the matrix points may be stimulated by heat which helps accelerate the healing process, while at the same time minimizing adverse effects such as scarring or changes in the normal skin pigmentation.
The researcher can determine Port wine stain areas treated with the Matrix Radiofrequency device will have improved Port wine stain blanching responses as compared to those areas treated by pulsed dye laser.
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
- •Port Wine Stain Birthmarks suitable for comparison testing
- •Age > 18 years of age
排除标准
- •Less than 18 years old
- •Are pregnant or breastfeeding
- •Other history assess by the investigator
结局指标
主要结局
Medical Tool
时间窗: 8 weeks
Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks
次要结局
- Port Wine Stain blanching(8 weeks)
研究者
Beckman Laser Institute and Medical Center
J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering
University of California, Irvine