Phase II Clinical Trial is to Compare Epidermal Temperature Measurements During 1.Laser Treatment at Standard Treatment Energies 2.Cryogen Spray Cooling (CSC) Plus Laser Treatment. 3.Contact Cooling Plus Laser Treatment.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- skin temperature during laser treatment
研究概览
简要总结
Lasers are the treatment modality of choice for Port Wine Stain birthmarks.The epidermis is not totally spared due to partial absorption of energy therein by melanin that presents an optical barrier through which the light must pass to reach the underlying blood vessels. Absorption of laser energy by melanin causes localized heating in the epidermis, which may, if not controlled, produce permanent complications such as hypertrophic scarring or dyspigmentation.
详细描述
The researchers want to establish a correlation between non-invasive skin temperature measurements and the minimum laser energy during skin laser treatment using cryogen spray cooling.
This study would eliminate the need for test pulses to estimate the safe and acceptable radiant exposure prior to laser treatment.
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
- 7 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •7 years of age and older with diagnosis of port wine stain birthmark
- •18 years of age and older with no port wine stain
- •non-pregnant women
- •apparent good health
排除标准
- •age less than 7 years old
- •pregnant women
- •history of photodermatoses or skin cancer
- •current use of photosensitizing drugs
研究组 & 干预措施
cooling spray
cooling spray during laser treatment
干预措施: cooling spray during laser treatment (Procedure)
结局指标
主要结局
skin temperature during laser treatment
时间窗: 90 days
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