ABSTRACT
The primary objective of this double-blind, randomized, controlled clinical trial was to assess the use of azithromycin dihydrate in oral suspension form in the treatment of impetigo in children. The secondary objectives were to compare the efficacy and safety of two presentations of azithromycin dihydrate in the treatment of impetigo in children, on wound healing and on wound pruritus. After screening and obtaining informed consent of the parents or legal guardians, a total of 100 patients ranging in age from 2-8 years old and presenting impetigo were randomized to one of two groups for a 3-day treatment period using azithromycin dihydrate in oral suspension in single doses of 10mg/kg/day: Group A (manufactured by Merck S.A.), and Group B (manufactured by Pfizer). Patients returned to the study center at the end of the 3-day treatment (Visit 2) and 7 days after the Pretreatment visit (Visit 3) for efficacy assessments and safety monitoring. Pretreatment demographic data and impetigo characteristics (type, location, number of lesions, pruritus) were homogenous between treatment groups. At the end of the study, all patients in both groups presented either ?improvement? or ?cured? lesions, with the majority (72.9%) of the patients presenting ?cured? lesions. We observed a statistically significant decrease in pruritus severity at Visit 2 and Visit 3 in relation to pretreatment, with no significant between-group difference at either study visit. Reported adverse events were transient and mild-to moderate in severity in both treatment groups, with no serious adverse events reported during the study. Based on the data collected during this study, we conclude that the two presentations of azithromycin were safe and effective in the treatment of impetigo in the population evaluated.