Photodynamic Therapy of Actinic Keratosis of the Face and Scalp With and Without Prior Curettage
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Complete lesion response rate
研究概览
简要总结
Guidelines for photodynamic therapy (PDT) of actinic keratosis recommend pretreatment with curettage. The impact of curettage on the treatment effect is, however, not known. The present study aimed to evaluate whether daylight-PDT without curettage would reduce treatment effect compared to daylight-PDT with curettage.
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
- Single (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
- •Multiple actinic keratosis on the forehead or scalp
排除标准
- •Known allergy to methyl aminolevulinate
- •Porphyria
- •Pregnancy
- •Lactation
研究组 & 干预措施
PDT with no curettage
干预措施: No curettage (Drug)
Standard PDT
干预措施: Curettage (Drug)
结局指标
主要结局
Complete lesion response rate
时间窗: Treatment efficacy was evaluated 3 months after PDT
Complete lesion response rate, was defined as the number of completely responding lesions divided by the total number of treated lesion in each field. Complete lesion response was defined as complete disappearance of the lesion both by palpation and visually.
次要结局
未报告次要终点
研究者
Ida M. Heerfordt
Principal investigator, MD, PhD
Bispebjerg Hospital