Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks: Comparison of 577 nm Versus 595 nm Wavelengths
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Improvement in blanching for the 577 nm Pulsed Dye Laser therapy in comparison with 595 nm
研究概览
简要总结
Port wine stain are a congenital, progressive vascular malformation of human skin. The pulsed dye laser is approved by the Food and Drug Administration for the treatment of choice. However, the degree of port wine stain blanching seen following pulsed dye laser treatment remains variable and unpredictable. If the ultimate standard required is complete lesion blanching, the average success rate is below 10%, even after undergoing numerous pulsed dye laser treatments. Moreover, less than 50% of patients achieve 50% fading of their Port wine stain in response to pulsed dye laser therapy.
详细描述
The researchers' specific aim is to determine whether the use of the pulsed dye laser operating at a wavelength of 577 nm will improve therapeutic outcome as compared to a pulsed dye laser operating at 595 nm.
The researcher can treat port wine stain treated using a pulsed dye laser operating at a wavelength of 577 nm and the other half at a wavelength of 595 nm. The researcher can determine that the 577 nm pulsed dye laser improved port wine stain blanching responses more than the areas treated with 595 nm.
The degree of port wine stain blanching which will determine by visible reflectance spectroscopy skin imaging device measurements. Post-treatment blanching responses can compare with pre-treatment measurements of port wine stain fractional blood volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 6 Months 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 > 6 months 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
- •Inability to understand and carry out instructions
结局指标
主要结局
Improvement in blanching for the 577 nm Pulsed Dye Laser therapy in comparison with 595 nm
时间窗: 8 weeks
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