NCT00987246已完成3 期
Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 40
- 主要终点
- Histological status of AK target lesion
研究概览
简要总结
The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).
详细描述
To investigate as primary objective:
- Superiority to placebo and non-inferiority to LAS106521 measured by histological clearance of one predefined target lesion;
To investigate as secondary objective:
- Superiority to LAS106521
- Improvement of treated lesions (lesion response)
- Assessment of tolerability and safety by physicians global assessment score (PGA, PGT)
- Patient's assessment of tolerability and efficacy and patient's compliance
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have at least 4 but not more than 10 clinically confirmed AK target lesions of mild to moderate intensity within the face/forehead or bald scalp (excluding eyelids, lips, and mucosa), i.e. actinic keratosis grade I and II according to Olsen EA et al. 1991
- •Woman of childbearing potential are allowed to participate in this study only if they use a highly effective method of contraception
排除标准
- •Have received effective treatment of AK in the three months preceding this clinical trial
- •Have known hypersensitivity to LAS41005 or LAS106521
- •Have currently other malignant or benign tumors of the skin within the treatment area (e.g. malignant melanoma, basal cell carcinoma, squamous cell carcinoma)
- •Patient's taking phenytoin
- •Show cornu cutaneum like alterations of the skin in the face or the bald scalp (target area)
研究组 & 干预措施
LAS41005
Experimental
干预措施: LAS41005 (Drug)
LAS106521
Active Comparator
干预措施: LAS106521 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo Gel (Drug)
结局指标
主要结局
Histological status of AK target lesion
时间窗: Day 140
次要结局
未报告次要终点
研究者
研究点 (40)
Loading locations...
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