A Phase III 3 Arms, Multicenter, Randomised, Investigator-blind Study to Assess the Efficacy and Safety of Ozenoxacin 1% Cream Applied Twice Daily for 5 Days Versus Placebo in the Treatment of Patients With Impetigo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 465
- 试验地点
- 19
- 主要终点
- Clinical Success
研究概览
简要总结
This is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo comparison), superiority clinical study comparing ozenoxacin cream versus placebo and retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm
- •Additionally for patients < 12 years the total area will not exceed a maximum of 2% of the body surface area.
- •Total Skin Infection Rating Scale (SIRS) score of at least 8, including pus/exudate score of at least 1
排除标准
- •Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic.
- •Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)
研究组 & 干预措施
ozenoxacin placebo
cream
干预措施: ozenoxacin placebo (Drug)
ozenoxacin 1% cream
1% cream
干预措施: ozenoxacin 1% cream (Drug)
retapamulin 1% ointment
1% ointment
干预措施: retapamulin 1% ointment (Drug)
结局指标
主要结局
Clinical Success
时间窗: 2 weeks
Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical succes at Visit 3 was defined as: SIRS score 0 for exudates/pus, crusting, tissue warmth and pain and no more than 1 each for erythema/inflammation, tissue edema and itching such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The SIRS is a severity index based on seven signs or symptoms: * Exudate/pus * Crusting * Erythema/inflammation * Tissue warmth * Tissue oedema * Itching * Pain Each sign/symptom is rated on a scale from 0 to 6: 0 = absent 1 2 = mild 3 4 = moderate 5 6 = severe
次要结局
未报告次要终点