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Anais Brasileiros de Dermatologia

Print version ISSN 0365-0596On-line version ISSN 1806-4841


GONTIJO, Bernardo et al. Evaluate of the efficacy and safety of tacrolimus ointment 0,03% to treat atopic dermatitis in pediatric patients. An. Bras. Dermatol. [online]. 2008, vol.83, n.6, pp.511-519. ISSN 0365-0596.

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 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.

Keywords : Child; Dermatitis; Dermatitis, atopic; Eczema; Tacrolimus.

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