NCT00133848已完成3 期
A Randomised, Double-blind, Multicentre, Superiority Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of Topical 1% SB-275833 Ointment Versus Placebo Ointment Applied Twice Daily for 5 Days in the Treatment of Adults and Paediatric Subjects With Impetigo.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 22
- 主要终点
- Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.
研究概览
简要总结
The goal of this study is to determine if topical SB-275833 ointment, 1% is more effective than a placebo ointment in the treatment of primary impetigo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 9 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have primary impetigo with total lesion area being 100 square centimeters or less.
- •Women who could bear children must have a negative urine pregnancy test and agree to either abstain from sexual intercourse or the use of specific effective contraceptive measures.
排除标准
- •Any signs and symptoms of systemic infection.
- •Any serious underlying disease that could be imminently life threatening.
结局指标
主要结局
Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.
次要结局
- Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits.
研究者
研究点 (22)
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