Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Improve PWS lesion blanching.
研究概览
简要总结
The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.
详细描述
Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization.
The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 years of age and older
- •Have PWS suitable for comparison testing as determined by the study doctor
排除标准
- •Less than 16 years old
- •Are pregnant
- •Have skin cancer
- •Currently taking immunosuppressive or steroids or photosensitizing drugs
- •Current participation in any other investigational drug evaluation
- •Concurrent use of known photosensitizing drugs
研究组 & 干预措施
Pulsed Dye Laser
Pulsed Dye Laser
干预措施: Pulsed Dye Laser (Device)
Topical Antiangiogenic
Topical Antiangiogenic Agents
干预措施: Topical Antiangiogenic (Drug)
结局指标
主要结局
Improve PWS lesion blanching.
时间窗: 8 weeks
次要结局
- To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome.(8 weeks)
研究者
Beckman Laser Institute and Medical Center
J S Nelson, M.D., Ph.D.,Professor of Surgery and Biomedical Engineering
University of California, Irvine