Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Port Wine Stain response to laser treatment
研究概览
简要总结
The purpose of this study is to improve port wine stain therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser therapy and topical ranibizumab will improve port wine stain therapeutic outcome.
详细描述
Combined use of pulsed dye laser to induce port wine stain blood vessel injury, and ranibizumab to prevent port wine stain blood vessel angiogenesis and recanalization after laser therapy, will improve port wine stain lesion blanching.
After pulsed dye laser treatment of the entire port wine stain, topical ranibizumab will be applied to two of the test sites for two weeks following pulsed dye laser therapy. The degree of port wine stain blanching which will be quantified objectively using visible reflectance spectroscopy measurements. port wine stain test site blanching responses following the combined use of pulsed dye laser and topical ranibizumab will be compared with pulsed dye laser only and with the baseline controls.
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
- 18 Years 至 —（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 > 18 years of age
排除标准
- •History of photodermatoses or skin cancer
- •use of known photosensitizing drugs
- •use of immunosuppressive drugs or systemic steroids
- •Pregnancy
研究组 & 干预措施
Ranibizumab
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
干预措施: Ranibizumab (Drug)
Pulsed Dye Laser
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
干预措施: Pulsed Dye Laser (Device)
结局指标
主要结局
Port Wine Stain response to laser treatment
时间窗: 8 weeks
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
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