Safety and Efficacy of Mupirocin Gel in Children With Impetigo (NCT04287777) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of Mupirocin Gel in Children With Impetigo
Spain467 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range18 Months – 15 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 investigato…
What they're measuring
1
Clinical cure at the end of treatment by SIRS assessed by blind observer
Timeframe: Day 8
2
Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 8