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Previous Volume 337:816-821 September 18, 1997 Number 12 Next

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ABSTRACT

Background Tacrolimus (FK 506) is an effective immunosuppressant drug for the prevention of rejection after organ transplantation, and preliminary studies suggest that topical application of tacrolimus is effective in the treatment of atopic dermatitis.

Methods We conducted a randomized, 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 cm² of skin for three weeks. The primary end point 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 median percentage decrease in the summary score for dermatitis on the trunk and extremities was 66.7 percent for the 54 patients receiving 0.03 percent tacrolimus, 83.3 percent for the 54 patients receiving 0.1 percent tacrolimus, 75.0 percent for the 51 patients receiving 0.3 percent tacrolimus, and 22.5 percent for the 54 patients receiving vehicle alone (P<0.001). The results for the face and neck were similar. The differences among the three tacrolimus groups were not statistically significant. A sensation of burning at the site of application was the only adverse event that was significantly more frequent with tacrolimus than with vehicle alone (P<0.001). Throughout the study, most patients in all three tacrolimus groups had blood concentrations of tacrolimus below 0.25 ng per milliliter. The highest concentration was 4.9 ng per milliliter, which was reported in the group receiving 0.3 percent 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.

Source Information

From the Departments of Dermatology at Heinrich Heine University, Düsseldorf, Germany (T.R.); Ludwig Maximilians University, Munich, Germany (T.B.); Albert Ludwigs University, Freiburg, Germany (E.S.); Latvian Medical Academy, Riga, Latvia (A.R.); Albert Szent-Györgyi Medical University, Szeged, Hungary (A.D.); University of Amsterdam, Amsterdam (J.D.B.); the Dermatology Clinic, Warsaw, Poland (S.J.); George Eliot Hospital, Nuneaton, United Kingdom (I.A.); Marselisborg Hospital, Århus, Denmark (K.T.-P.); Saint Joseph Hospital, Paris (F.D.); University of Milan, Milan, Italy (A.F.); and Helsinki University Central Hospital, Helsinki, Finland (S.R.).

Address reprint requests to Prof. Ruzicka at Heinrich Heine University, Department of Dermatology, Moorenstr. 5, D-40225 Düsseldorf, Germany.

Full Text of this Article

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