NCT01020994已完成2 期
Explorative, Double-blind, Randomized, Controlled Multi-center Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41003 Once Daily Versus LAS189962 and LAS189961 in the Treatment of Superficial Infected Eczema
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
- 150
- 试验地点
- 1
- 主要终点
- Combination of clinical and microbial treatment success
研究概览
简要总结
The aim of the study is to determine the efficacy and safety of topical application of LAS41003 in comparison to LAS189962 and LAS189961 in the treatment of superinfected eczema.
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
- •Clinically diagnosed super-infected or impetiginized eczema
排除标准
- •Patients who have general signs of systemic infections like fever, malaise, lymphangitis or swollen lymph nodes and / or need systemic antibiotic treatment
- •Patients who have a bacterial skin infection which, due to depth and severity, could not be appropriately treated with a topical antimicrobial or antiseptic medication
- •Diagnose of the following disease:
- •Known active tuberculosis or any history of past tuberculosis of skin
- •Suspected or proven parasitic infection of the treatment site (e.g. scabies)
- •Psoriasis
- •Suspected or proven viral infection of skin (e.g. Herpes)
- •Localization of the superficial infected eczema:
- •Palms of the hands
- •Sole of a foot
- •Have received any topical treatment with antibiotics, antimycotics, immunomodulators and corticosteroid preparations within the last 2 weeks before treatment with IMP
研究组 & 干预措施
LAS41003
Experimental
干预措施: LAS41003 (Drug)
LAS189962
Active Comparator
干预措施: LAS189962 (Drug)
LAS189961
Active Comparator
干预措施: LAS189961 (Drug)
结局指标
主要结局
Combination of clinical and microbial treatment success
时间窗: Day 14
次要结局
- Safety:Physical examination at EoT, AEs/SAEs during the entire study(2 weeks)
研究者
研究点 (1)
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