Title
Safety and Efficacy of Mupirocin Gel in Children With Impetigo
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
Phase
Phase 3Lead Sponsor
Reig Jofre GroupStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
ImpetigoIntervention/Treatment
Mupirocin gel Mupirocin ointment ...Study Participants
467The 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.
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
Topical treatment of Mupirocin ointment 20 mg/g TID for 7 days
Topical administration of Placebo (ointment) TID during 7 days
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
Topical administration of Mupirocin ointment 20mg/g TID for 7 days.
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.
