NCT02125669已完成不适用
The Role of the 595 nm Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas at Low Risk Anatomical Sites: Outcome of a Double Blind Randomized Placebo Controlled Trial
Hautklinik Darmstadt0 个研究点目标入组 100 人开始时间: 2012年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- complete response
研究概览
简要总结
Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking due to inconsistent design of available studies. The purpose of this study is to evaluate the PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low risk anatomical sites in an evidence based study setting.
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
- Double (Participant, 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
- •histologically confirmed unpigmented sBCC on the trunk and extremities
- •maximal tumour diameter 30 mm
排除标准
- •Fitzpatrick skin type >III
- •pregnancy
- •previous BCC treatment within 4 weeks
- •coagulation disorders
- •photo sensitizing medication
- •any indication of poor compliance
结局指标
主要结局
complete response
时间窗: 9 months
次要结局
- patients satisfaction(9 months)
- side effects(9 months)
- reduction of tumor diameter and tumor thickness(9 months)
研究者
Maurizio Podda
PD Dr. med.
Hautklinik Darmstadt
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