NCT00986856终止4 期
A Phase IV Study Comparing Clinical and Bacteriological Efficacy of Fucidin® Cream With Fucidin® Cream Vehicle in the Treatment of Impetigo in Paediatric Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- LEO Pharma
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).
研究概览
简要总结
To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment of impetigo in paediatric patients.
To assess the validity of in vitro susceptibility-testing of S. aureus to fusidic acid as a prediction of clinical and bacteriological outcome in impetigo patients treated with Fucidin® cream.
To investigate the genetic relationship between S. aureus-strains isolated from impetigo patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of impetigo,
- •Patients aged 2-11 years,
- •Patients of either sex,
- •Patients whose parent(s) has(ve) provided written consent, AND
- •Patients with a severity score of 1 for at least one of the following signs: pustules/infected bullae, erythema and infiltration/induration.
排除标准
- •Patients with other active inflammatory dermatitis at the area of impetigo,
- •Patients with a temperature above 38.5 C rectally (or equivalent), OR
- •Patients who have been administered topical or systemic Fucidin® or other antibacterial agents within the previous 4 weeks.
研究组 & 干预措施
Fucidin® cream
Experimental
干预措施: Fucidin® cream (Drug)
Fucidin® cream vehicle
Placebo Comparator
干预措施: Fucidin® cream (Drug)
结局指标
主要结局
Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).
时间窗: EOT: Visit at Day 25
次要结局
- Number of Patients With Bacteriological Success at EOT(EOT: Visit at day 25)
- Number of Patients With Clinical Success at Visit 3(Visit 3: Day 11)
- Number of Patients With Clinical Success at EOT(EOT: Visit at day 25)
- The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).(EOT: Visit at day 25)
- Number of Patients With Bacteriological Success at Visit 3(Visit 3: Day 11)
- Number of Patients With Clinical Success at Visit 2(Visit 2: Day 4)
- Number of Patients With Bacteriological Success at Visit 2(Visit 2: Day 4)
研究者
研究点 (2)
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Fucidin® Cream in the Treatment of ImpetigoA phase IV study comparing clinical and bacteriological efficacy of Fucidin® cream with Fucidin® cream vehicle in the treatment of impetigo in paediatric patientsPatients with a clinical diagnosis of impetigo, aged 2-11 years, with a severity score of minimum 1 for at least one of the following signs: Pustules/infected bullae, erythema and infiltration/induration.MedDRA version: 6.1Level: PTClassification code 10021531EUCTR2004-002687-14-GBEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)360
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