A two-phase multicenter study assessed once- versus twice-daily topical pimecrolimus cream 1% for prevention of disease relapse in 300 outpatients with mild-severe atopic dermatitis (AD) aged 2-17 years. Patients initially received open-label topical pimecrolimus cream b.i.d. until complete clearance or for up to 6 weeks. Those who had a decrease of 1 point or less on the Investigator's Global Assessment (IGA) score (n = 268), received topical pimecrolimus once or twice daily for up to 16 weeks. The primary efficacy endpoint of the double-blind phase was disease relapse, with an IGA score of 3 or higher and a pruritus score of 2 or more. The relapse rate was lower in ...