NCT01475071已完成3 期
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Lesion Response
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 with Aktilite™ lamp 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
- Single (Investigator)
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 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
Metvix and daylight
Experimental
干预措施: Metvix and natural daylight PDT (Drug)
Metvix and lamp
Active Comparator
干预措施: Metvix and conventional PDT (Drug)
结局指标
主要结局
Lesion Response
时间窗: Week12
Percent of lesions treated at Baseline, in complete response at Week 12
Pain Score
时间窗: Baseline (during procedure), assessed after procedure
Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)
次要结局
未报告次要终点
研究者
研究点 (2)
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