Phase I Combined Use of Pulsed Dye Laser and Rapamycin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- improve port wine stain (PWS) therapeutic outcome
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 researchers want to determine whether the combined use of pulsed dye laser therapy and rapamycin will improve PWS therapeutic outcome.
详细描述
The researchers want to combined use of pulsed dye laser to induce port wine stain blood vessel injury, and rapamycin directly inhibits the proliferation of vascular endothelial cells driven by vascular endothelial growth factor which preventing port wine stain angiogenesis and recanalization, to improve port wine stain lesion blanching.
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.
排除标准
- •Pregnancy.
- •Abnormal blood hematology or chemistry blood tests or urine analysis.
- •History of cancer, History of high cholesterol, lipids or liver disease
- •Allergy to macrolide drugs (e.g., erythromycin).
- •Any therapy within the previous two months to the proposed PWS treatment sites.
- •Concurrent use of known photosensitizing drugs,immunosuppressive drugs or systemic steroids,antifungals, antiepileptics, HIV protease inhibitors, cimetidine, cisapride, clarithromycin, dannzol, diltiazem, erythromycin, metoclopramide, rifabutin, rifampin, rifapentine, troleandomycin, or verapamil.
研究组 & 干预措施
Treatment of Port Wine Stain
Rapamycin Treatment of Port Wine Stain
干预措施: Rapamycin Treatment of Port Wine Stain (Drug)
结局指标
主要结局
improve port wine stain (PWS) therapeutic outcome
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, M.D., Ph.D.,Professor of Surgery and Biomedical Engineering
University of California, Irvine