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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
467
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
CAP Torreblanca
Seville, Andalusia, Spain
CAP La Algaba
Seville, Andalusia, Spain
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).
Time frame: 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
Time frame: Day 8
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).
Time frame: 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
Time frame: Day14
Total SIRS score at the end of treatment and follow-up by blind observer
Time frame: 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
Time frame: 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.
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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, Madrid, Spain
...and 10 more locations
Time frame: 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
Time frame: Day 8 and 14