Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12
研究概览
简要总结
The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy in subjects with mild actinic keratoses (intra-individual comparison)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Male or female above 18 years;
- •Subject with clinical diagnosis of mild Actinic Keratosis (AK) on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);
排除标准
- •Subject with clinical diagnosis of at least one severe AK on TAs
- •Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
- •Subject with pigmented AK on the TAs
研究组 & 干预措施
Daylight
Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline
干预措施: Metvix® (Drug)
Daylight
Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline
干预措施: Photodynamic Therapy Daylight (Procedure)
Conventional treatment
Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline
干预措施: Metvix® (Drug)
Conventional treatment
Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline
干预措施: Photodynamic Therapy Blue light (Procedure)
结局指标
主要结局
Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12
时间窗: Baseline and Week 12
The number of lesions is assessed at baseline (before treatment) and 12 weeks later. The difference in lesions is recorded for each patient. The mean of disappeared lesions are then calculated for all patients.
次要结局
- Pain Assesment(at inclusion (after treatment))
- Lesions Disappearance Rate at 1 Months From Baseline.(0(baseline),1 month)
- Lesions Disappearance Rate at 6 Months From Baseline.(0(baseline), 6 month)