A SHORT-TERM TRIAL OF TACROLIMUS OINTMENT FOR ATOPIC-DERMATITIS

Background Tracrolimus (FK 506) is an effective immunosuppressant drug for the prevention of rejection after organ transplantation, and prel iminary studies suggest that topical application of tacrolimus is effe ctive in the treatment of atopic dermatitis. Methods We conducted a ra ndomized, double-blind, multicenter study that compared 0.03 percent, 0.1 percent, and 0.3 percent tacrolimus ointment with vehicle alone in patients with moderate-to-severe atopic dermatitis. The ointment was applied twice daily to a defined, symptomatic area of 200 to 1000 cm(2 ) of skin for three weeks, The primary end paint was the change in the summary score for erythema, edema, and pruritus between the first and last days of treatment. Results After three weeks of treatment, the m edian percentage decrease in the summary scare for dermatitis on the t runk and extremities was 66.7 percent for the 54 patients receiving 0. 03 percent tacrolimus, 83.3 percent far the 54 patients receiving 0.1 percent tacrolimus, 75.0 percent for the 51 patients receiving 0.3 per cent tacrolimus, and 22.5 percent for the 54 patients receiving vehicl e alone (P < 0.001). The results for the face and neck were similar, T he differences among the three tacrolimus groups were not statisticall y significant. A sensation of burning at the site of application was T he only adverse event that was significantly more frequent with tacrol imus than with vehicle alone (P < 0.001). Throughout the study, most p atients in all three tacrolimus groups had blood concentrations of tac rolimus below 0.25 ng per milliliter. The highest concentration was 4. 9 ng per milliliter, which was reported in the group receiving 0.3 per cent tacrolimus. Conclusions The short-term application of tacrolimus ointment Is effective in the treatment of atopic dermatitis, with the sensation of burning being the main side effect. (C) 1997, Massachuset ts Medical Society.