Combined Bipolar Radiofrequency and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percent Change in Blanching of Port Wine Stain
研究概览
简要总结
Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin. However, even though the pulsed dye laser is considered as the treatment of choice for Port wine stain Birthmark the degree of fading can remain variable and unpredictable after laser treatment.
详细描述
The researcher want to use the combination of radiofrequency electrical energy with pulsed dye laser light energy which can improve therapeutic outcome of Port wine stain Birthmark. This investigational device is essentially a combination of two commercially available systems cleared for marketing (K044351 and K052324) provided by Candela Laser Corporation.
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
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Port Wine Stain suitable for comparison testing
- •Age > 12 years of age; minor will be accompanied in the room by parents or guardians during laser treatment
- •Apparent good health as documented by medical history
- •Ability to understand and carry out subject instructions
排除标准
- •History of photodermatoses or skin cancer
- •Any therapy within the previous two months to the proposed port wine stain treatment sites
- •Current participation in any other investigational drug or device evaluation
- •Concurrent use of known photosensitizing drugs
- •Inability to understand and carry out instructions
结局指标
主要结局
Percent Change in Blanching of Port Wine Stain
时间窗: 8 weeks
Port Wine Stain blood volume fractions in the skin before (fB1), and 8 weeks after (fB2) treatment will be determined using the corresponding visual reflectance spectra measured at the treatment sites. The primary outcome, degree of blanching, B, is computed as B = (fB1-fB2)/fB1.
次要结局
未报告次要终点
研究者
Beckman Laser Institute and Medical Center
J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering
University of California, Irvine