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Safety and Efficacy of Mupirocin Gel in Children With Impetigo

Phase 3
Completed
Conditions
Impetigo
Interventions
Registration Number
NCT04287777
Lead Sponsor
Reig Jofre Group
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
467
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Mupirocin ointmentMupirocin ointmentTopical administration of Mupirocin ointment 20mg/g TID for 7 days.
Mupirocin gelMupirocin gelTopical administration of Mupirocin gel 20 mg/g BID for 7 days
PlaceboPlaceboTopical administration of Placebo (ointment) TID for 7 days
Primary Outcome Measures
NameTimeMethod
Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 8Day 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 observerDay 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).

Secondary Outcome Measures
NameTimeMethod
SIRS total score at the end of treatment and follow-up by investigatorDay 8 and 14

SIRS total Score at Day 8 and Day 14 visits, assessed by the investigator

Clinical cure at the end of follow up by SIRS assessed by blind observerDay14

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).

Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 14Day14

proportion of subjects with no additional antibiotic therapy required to treat impetigo

Total SIRS score at the end of treatment and follow-up by blind observerDay 8 and 14
Clinical cure at the end of treatment and follow-up by investigatorDay 8 and 14

Proportion of subjects with clinical cure at the Day 8 and Day 14 visits, assessed by investigator, according to protocol criteria.

Bacteriology cure at follow-upDay 14

Bacteriology eradication at the end of follow-up period according to culture at screening and follow up visits

Trial Locations

Locations (20)

CAP Torreblanca

🇪🇸

Sevilla, Andalucia, Spain

CAP La Algaba

🇪🇸

Sevilla, Andalucia, Spain

CAP Vallcarca-St. Gervasi

🇪🇸

Barcelona, Catalonia, Spain

CAP Corbera de Llobregat

🇪🇸

Corbera De Llobregat, Catalonia, Spain

CAP Amadeu Torner

🇪🇸

L'Hospitalet De Llobregat, Catalonia, Spain

CAP Mossèn Cinto Verdager

🇪🇸

L'Hospitalet de Llobregat, Catalonia, Spain

CAP Florida Nord

🇪🇸

L'HOspitalet de Llobregat, Catalonia, Spain

CAP Rambla Ferran

🇪🇸

Lleida, Catalonia, Spain

CAP Maria Bernades

🇪🇸

Viladecans, Catalonia, Spain

H.U. Sureste

🇪🇸

Arganda del Rey, Madrid, Spain

Scroll for more (10 remaining)
CAP Torreblanca
🇪🇸Sevilla, Andalucia, Spain

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