Avaliação da eficácia e segurança do tacrolimo pomada 0, 03% no tratamento da dermatite atópica em pacientes pediátricos

Abstract

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 (Protopic®) 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 Protopic® twice a day for six weeks. Primary efficacy criterion was clinical improvement ≥ 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 ≥90%. 45.5% of patients (1st week) decreased easi and 61.8% (6th week) (p<0,001). %bsa decreased 30.4% and 55.5% in the first and sixth week. Improvement was also significant when measured by itching (p<0,001). Most frequent adverse 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. © 2008 by Anais Brasileiros de Dermatologia.