Abstract
Methods: This was a multicenter, two-phase study of 206 patients 2 to 15 years of age with moderate to severe atopic dermatitis. In the fi rst phase of the study, the goal was to stabilize patient symptoms. The stabilization phase was divided into two periods. The fi rst period was double-blinded, and patients were assigned to use tacrolimus ointment, 0.03%, or alclometasone ointment, 0.05%, for 4 days. During the second period, all patients received tacrolimus ointment, 0.03% (open-label), for up to 16 weeks. The maintenance phase was a randomized, double-blind, placebo-controlled evaluation of tacrolimus ointment, 0.03%, or vehicle ointment applied once daily or three times weekly to the previously affected sites.
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