Ph-III Randomized, Multicentric, Controlled , Non-inferiority Trial to Evaluate the Safety and Efficacy of Mupirocin Gel 20 mg/g Versus Mupirocin Ointment 20 mg/g and Placebo in the Treatment of Impetigo in Paediatric Population
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 467
- 试验地点
- 20
- 主要终点
- Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 8
研究概览
简要总结
The purpose of the study is to show non inferiority in terms of safety and efficacy of topical administration BID (Twice daily) of Mupirocin Gel 20 mg/g compared to topical administration of Mupirocin Ointment 20 mg/g TID (three times daily) (Bactroban) in the treatment of impetigo in paediatric population.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 months and 15 years at the signature of informed consent
- •Impetigo susceptible to be treated with topical mupirocin and non requiring systemic antibiotic treatment (maximum of 4 different affected areas and no fever).
- •Global score of Skin Infection Rating Scale (SIRS) ≥ 4, with positive value (≥ 1) in at least 3 of the 5 categories evaluated.
- •Signature of informed consent by parent or legal tutor and, in case of mature minor (12 years or more), signature of informed assent.
- •Patient or parent's ability to understand and fulfill with protocol requirements.
- •In potentially pregnant patients, negative pregnancy urine test at baseline and use of reliable contraception double barrier methods during the trial.
排除标准
- •Allergy to any compound of the trial treatments
- •Have received systemic treatment with antibiotics or steroids, during the week prior to the baseline visit.
- •Have received topical treatment with corticosteroids, antibiotics or antifungals, during the 48 hours prior to the baseline visit.
- •Primary or secondary immunodeficiency.
- •Have received cytostatic or immunosuppressive treatment three months prior to baseline.
- •Any skin disorder that could interfere with the evaluation of the results of impetigo, such as presence of staphylococcal or streptococcal ecthyma, cellulitis, furunculosis, acute dermatitis, contact dermatitis or impetiginized eczema.
- •Diabetes mellitus.
- •Infection that, in the investigator's opinion, should be treated with systemic antibiotic.
- •Any medical condition which, in the investigator's opinion, contraindicates the subject's participation in the trial.
- •Forecast of little cooperation, non-compliance with medical treatment or low credibility.
- •Have participated in any clinical investigation with medicine within 30 days prior to basal visit.
研究组 & 干预措施
Placebo
Topical administration of Placebo (ointment) TID for 7 days
干预措施: Placebo (Drug)
Mupirocin gel
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
干预措施: Mupirocin gel (Drug)
Mupirocin ointment
Topical administration of Mupirocin ointment 20mg/g TID for 7 days.
干预措施: Mupirocin ointment (Drug)
结局指标
主要结局
Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 8
时间窗: Day 8
proportion of subjects with no additional antibiotic therapy required to treat impetigo
Clinical cure at the end of treatment by SIRS assessed by blind observer
时间窗: Day 8
Proportion of subjects with clinical cure at the Day 8 visit, assessed by blind observer, according to criteria described in the Protocol (SIRS \< or = 2).
次要结局
- SIRS total score at the end of treatment and follow-up by investigator(Day 8 and 14)
- Clinical cure at the end of follow up by SIRS assessed by blind observer(Day14)
- Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 14(Day14)
- Total SIRS score at the end of treatment and follow-up by blind observer(Day 8 and 14)
- Clinical cure at the end of treatment and follow-up by investigator(Day 8 and 14)
- Bacteriology cure at follow-up(Day 14)