摘要
background: tacrolimus ointment has been shown to be effective in treatment of atopic dermatitis. objectives: to evaluate the efficacy and safety of 0.03% tacrolimus ointment (protopicˋ) in pediatric patients with mild, moderate and severe atopic dermatitis. methods: open, non-comparative, multicentric study carried out in brazil. 174 patients (ages from two to 10) with mild to severe atopic dermatitis were included. patients were instructed to apply protopicˋ twice a day for six weeks. primary efficacy criterion was clinical improvement %26gt; 90% assessed by the physician (clinical response global evaluation scale). other efficacy criteria included reduction of the eczema area severity index (easi), decrease of the affected body surface area (%bsa) and evaluation of the itching by the patients or their guardians (visual analogical scale). safety was evaluated by adverse events reported by patients and/or guardians or by investigators. results: thirty-three percent of patients showed clinical improvement %26gt; 90%. 45.5% of patients (1st week) decreased easi and 61.8% (6th week) (p%26lt;0,001). %bsa decreased 30.4% and 55.5% in the first and sixth week. improvement was also significant when measured by itching (p%26lt;0,001). most frequentadverse effects were: burning and itching. conclusion: 0.03% tacrolimus ointment is a safe and effective therapy for mild to severe atopic dermatitis in pediatric patients.