Multi-centre, Randomized, Investigator-blind, Intra-individual Active and Vehicle-controlled Study, Comparing Metvix Natural Daylight Photodynamic Therapy Versus Metvix Conventional Photodynamic Therapy in Subjects With Actinic Keratosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1
研究概览
简要总结
This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study.
The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.
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
- •Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the scalp on treated areas
- •Subject with two symmetrical treated areas half scalps or two half faces excluding ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no more than a twofold difference in terms of total number of lesions between the two TAs
排除标准
- •Subject with clinical diagnosis of at least one severe (Grade 3) AK on treated areas
- •Subject with pigmented AK on the treated areas
- •Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons
- •Subject with porphyria,
研究组 & 干预措施
NDL-PDT/c-PDT
Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy
干预措施: NDL-PDT (Drug)
NDL-PDT/c-PDT
Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy
干预措施: c-PDT (Drug)
NDL-PDT/placebo c-PDT
Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy
干预措施: NDL-PDT (Drug)
NDL-PDT/placebo c-PDT
Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy
干预措施: placebo c-PDT (Drug)
结局指标
主要结局
Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1
时间窗: Baseline, Week 12
The lesion complete response rate was defined as the percentage of pre-existing and treated lesions at Baseline that were assessed as clear (complete disappearance of the lesion, visually and by palpation) at Week 12. New lesions or the lesions in non-complete response were not not considered in the lesion response assessment. This outcome measure was analyzed as an intra-individual comparison between Metvix NDL-PDT on one side of the face/scalp and Metvix vehicle cream (placebo) c-PDT on the contralateral side (Group I).
次要结局
未报告次要终点