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Twice-daily versus once-daily topical pimecrolimus cream for relapse prevention in pediatric atopic dermatitis

A multicenter, randomized, double-blind trial enrolled 300 patients aged 2-17 years with mild-severe atopic dermatitis (AD) for treatment with once or twice daily pimecrolimus cream 1% for up to 16 weeks. The patients had been initially treated for up to 6 weeks with b.i.d. topical pimecrolimus cream until clearance. Those achieving a decrease of 1 point or more on the Investigator's Global Assessment (IGA) scale were then randomized to double-blind treatment with b.i.d. or q.d. pimecrolimus. Pimecrolimus was discontinued during disease remission (when IGA = 0). The primary endpoint of the double-blind phase was disease relapse (worsening requiring topical corticosteroids or additional/alternative therapy and confirmed by IGA score of 3 or more ...