A Pilot Study to Examine the Effectiveness of 595nM Pulsed Dye Lasers in the Treatment of Basal Cell Carcinoma and Squamous Cell Carcinoma in Situ
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Tumor Clearance
研究概览
简要总结
This is a research study to find out more about the use of the pulsed dye laser in the treatment of basal cell carcinoma and early stage squamous cell carcinoma that has not invaded deep into the skin. The purpose of this study is to determine whether the use of the pulsed dye laser (PDL) can completely clear or regress basal cell carcinoma or early stage squamous cell carcinoma.
Pulsed dye laser is a type of laser that is commonly used to treat lesions on the skin that have a prominent blood vessel component. It has been used to treat broken blood vessels on the face, hemangiomas in children and adults, leg veins, port wine stains, and other lesions with a prominent vascular component.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients requiring surgical excision (conventional or Mohs) for biopsy-proven basal cell carcinoma and biopsy-proven squamous cell carcinoma in situ that is clinically present at the pre-operative visit and measures greater than 0.4cm and less than 3cm in size.
- •Lesions in the Trunk, Extremities, and Scalp
- •Presence of clinically identifiable residual tumor.
- •Patients, males and females, aged 18-90 years.
- •Willing to participate.
- •Able to give informed consent.
排除标准
- •Age younger than 18 years
- •Location of lesion not in the Trunk, Extremities, and Scalp
- •Fitzpatrick skin type V or VI.
- •Prior history of known light sensitivity.
- •Pregnancy
- •Cognitive Impairment
研究组 & 干预措施
Control
No treatment administered
PDL Setting 1
PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes
干预措施: PDL Treatment (Procedure)
PDL Setting 2
PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses
干预措施: PDL Treatment (Procedure)
结局指标
主要结局
Tumor Clearance
时间窗: 21 to 36 days after the treatment
Review of the pathology report showing whether there was residual tumor or not. If there was no residual tumor in the pathology report from the confirmatory excision, the laser treatment was considered successful (tumor clearance).
次要结局
未报告次要终点
研究者
Dr. Shang I. Brian Jiang
Clinical Professor of Dermatology
University of California, San Diego