Clinical assessment of azithromycin dihydrate in the treatment of pediatric impetigo / Avaliação clínica de azitromicina di-hidratada no tratamento de impetigo pediátrico

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.

Clinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic origin / Avaliação clínica do uso de duas preparações de etinilestradiol e acetato de ciproterona em menstruação irregular de origem hiperandrogênica

We report on the results of a double-blind, randomized, controlled clinical trial comparing two preparations of ethinylestradiol and cyproterone acetate in the treatment of women of reproductive age presenting menstrual irregularities of hyper-androgenic origin. After obtaining informed consent, subjects were randomized to a 4-month treatment period consisting of one daily dose of 0.035mg ethinylestradiol + 2mg cyproterone acetate. The treatment regimen cycle consisted of one pill, once daily for 21 days, followed by a 7-day pill-free period. We compared the efficacy of two presentations of the drug combination after each treatment cycle (Visits 2, 3, 4, and 5) in establishment and maintenance of menstrual regulation, intensity of menstrual flow, and dysmenorrhea, as well as a comparison of the two presentations in terms of Global Satisfaction and Drug Satisfaction assessments performed by the patients and the investigating physician. At each study visit, drug compliance and use of concomitant medications, as well as incidence, severity and duration of adverse events were recorded. A total of 86 subjects were randomized to treatment, with 43 subjects in each treatment group. At Visit 2 and each subsequent visit, all patients in both treatment groups reported an episode of withdrawal bleeding during the 7-day hormone-free period. We observed a statistically significant (p<0.0001) decrease in the incidence of dysmenorrhea at each study visit in relation to the pretreatment assessment. There was a significant reduction (p<0.0001) in the number of subjects reporting intermenstrual bleeding at each study visit in both treatment groups. Global Satisfaction scores by the patient and physician increased significantly at each successive study visit in both treatment groups. There were no clinically significant changes in vital signs, weight, and body mass index throughout the study period in either group. The number of subjects reporting adverse events at each visit did not vary between treatment groups. The combined oral contraceptive pill containing ethinylestradiol and cyproterone acetate was found to be both effective and safe in the menstrual irregularities of hyper-androgenic origin (amenorrhea, dysmenorrhea, and intermenstrual bleeding) assessed in this study.