NCT00133874已完成3 期
An Observer-blind, Multicenter, Non-inferiority, Comparative Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, Versus Topical 2% Fusidic Acid Cream Applied Three Times Daily for 7 Days in the Treatment Adult 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
- 520
- 试验地点
- 70
- 主要终点
- Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.
研究概览
简要总结
The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age.
详细描述
A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo.
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
- 9 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
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 assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.
时间窗: 7 Days
次要结局
- Clinical response assessed at follow up visit. Microbiologic response at end of therapy and follow up visits. Impetigo lesion area measured at end of therapy and follow up visits.(7 Days)
研究者
研究点 (70)
Loading locations...
相似试验
已完成
3 期
Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo OintmentImpetigoNCT00133848GlaxoSmithKline210
已完成
3 期
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic DermatitisDermatitis, AtopicNCT02118792Pfizer764
已完成
3 期
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic DermatitisDermatitis, AtopicNCT02118766Pfizer763
已完成
2 期
AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type PsoriasisPsoriasisNCT01300052Pfizer68
已完成
2 期
Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic DermatitisDermatitis, AtopicNCT01602341Pfizer86