Impetigo
Conditions
Keywords
Impetigo, Mupirocin, Mupirocin gel, Mupirocin ointment, Impetigo in children
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.
Interventions
DRUGMupirocin gel
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
Topical treatment of Mupirocin ointment 20 mg/g TID for 7 days
DRUGPlacebo
Topical administration of Placebo (ointment) TID during 7 days
Sponsors
Reig Jofre Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical cure at the end of treatment by SIRS assessed by blind observer | 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). |
| Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 8 | Day 8 | proportion of subjects with no additional antibiotic therapy required to treat impetigo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 14 | Day14 | 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 observer | Day 8 and 14 | — |
| SIRS total score at the end of treatment and follow-up by investigator | Day 8 and 14 | SIRS total Score at Day 8 and Day 14 visits, assessed by the investigator |
| Clinical cure at the end of treatment and follow-up by investigator | Day 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-up | Day 14 | Bacteriology eradication at the end of follow-up period according to culture at screening and follow up visits |
| Clinical cure at the end of follow up by SIRS assessed by blind observer | Day14 | 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). |
Countries
Spain
Outcome results
None listed