NCT00991861已完成2 期
Double-blind, Randomized, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41007 Once Daily and LAS41007 Twice Daily Versus LAS106521 Gel Twice Daily 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
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Histological clearance of one pre-selected target lesion
研究概览
简要总结
The aim of this study is to determine the efficacy, safety and tolerability of either a once or twice daily topical application of LAS41007 compared to a twice daily application of LAS106521 in the treatment of actinic keratosis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 4-10 clinically assessed actinic keratosis grade I to II (according to Olsen et al, 1991) in the face/forehead and/or on the bald scalp
- •The diameter of each AK target lesion is not less than 0.5 cm and not greater than 1.5 cm
- •The target lesions must be located in overall 2 treatment areas with a size of 25 cm2 per treatment area
排除标准
- •Have evidence of clinically significant or unstable medical conditions such as:
- •metastatic tumor or tumor with high probability of metastatic spread
- •heart failure (NYHA class III or higher)
- •immunosuppressive disorder (e.g. HIV)
- •hematologic, hepatic, renal, neurologic or endocrine disorder.
- •collagen-vascular disorder (e.g. cerebrovascular disorder or other bleedings).
- •gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage)
- •Suffer from paresthesia in the treatment areas
- •Show Cornu cutaneum of the skin and/or hypertrophic AK lesions in the treatment areas
研究组 & 干预措施
LAS41007 o.d.
Experimental
Once daily
干预措施: LAS41007 o.d. (Drug)
LAS41007 b.i.d.
Experimental
Twice daily
干预措施: LAS41007 b.i.d. (Drug)
LAS106521
Active Comparator
干预措施: LAS106521 (Drug)
结局指标
主要结局
Histological clearance of one pre-selected target lesion
时间窗: Day 120
Complete clinical clearance of all target lesions in the treatment areas
时间窗: Day 120
次要结局
- Physician's Global Tolerability Assessment (PGT)(Day 120)
研究者
研究点 (1)
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