A study comprising an initial 6-week open-label phase followed by a 12-month disease control phase (DCP) in which adult atopic dermatitis (AD) patients were then randomized to tacrolimus 0.1% ointment or vehicle (2 days/week) was conducted. The criterion for entering the randomized phase was an Investigator Global Assessment (IGA) of 2 or less. If a flare developed during the DCP, open-label tacrolimus could be applied b.i.d. for one to six weeks until an IGA score of 2 or less was achieved. Patients then resumed their randomized treatment. In total, 257 entered the open-label phase and 90% were randomized to the DCP. Prophylactic use of twice-weekly tacrolimus ointment significantly reduced the number ...