A double-blind, randomized, active-controlled trial compared the effects of tacrolimus ointment 0.1% versus fluticasone ointment 0.005% in 566 patients with moderate to severe facial atopic dermatitis (AD). Treatments were administered twice daily for 3 weeks. The primary outcome was the percentage of patients responding with at least a 60% reduction in the modified Local Eczema Area and Severity Index (LEASI). Secondary outcomes included physician/patient global assessment of clinical response, patients' assessment of itch/sleep quality and switches to the other group if there was no satisfactory response at 3 weeks. At week 3, the percentage of responders was 93.3% and 87.8% in the tacrolimus and fluticasone groups, respectively (P=0.026). All secondary endpoints were ...