Safety and Efficacy of Mupirocin Gel in Children With Impetigo

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Impetigo

Intervention / Treatment
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* Drug: Mupirocin gel
* Drug: Mupirocin ointment
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mupirocin gel<br>Topical administration of Mupirocin gel 20 mg/g BID for 7 days | Drug: Mupirocin gel<br>* Topical administration of Mupirocin gel 20 mg/g BID for 7 days<br>|
| Active Comparator: Mupirocin ointment<br>Topical administration of Mupirocin ointment 20mg/g TID for 7 days. | Drug: Mupirocin ointment<br>* Topical treatment of Mupirocin ointment 20 mg/g TID for 7 days<br>* Other names: Bactroban;|
| Placebo Comparator: Placebo<br>Topical administration of Placebo (ointment) TID for 7 days | Drug: Placebo<br>* Topical administration of Placebo (ointment) TID during 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure at the end of treatment by SIRS assessed by blind observer | 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). | Day 8 | 
| Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 8 | proportion of subjects with no additional antibiotic therapy required to treat impetigo | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure at the end of follow up by SIRS assessed by blind observer | Proportion of subjects with clinical cure at the Day 14 visit, assessed by blind observer, according to criteria described in the protocol (SIRS < or = 2). | Day14 | 
| Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 14 | proportion of subjects with no additional antibiotic therapy required to treat impetigo | Day14 | 
| Total SIRS score at the end of treatment and follow-up by blind observer |  | Day 8 and 14 | 
| Bacteriology cure at follow-up | Bacteriology eradication at the end of follow-up period according to culture at screening and follow up visits | Day 14 | 
| Clinical cure at the end of treatment and follow-up by investigator | Proportion of subjects with clinical cure at the Day 8 and Day 14 visits, assessed by investigator, according to protocol criteria. | Day 8 and 14 | 
| SIRS total score at the end of treatment and follow-up by investigator | SIRS total Score at Day 8 and Day 14 visits, assessed by the investigator | Day 8 and 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impetigo, Mupirocin, Mupirocin gel, Mupirocin ointment, Impetigo in children