title: A short-term trial of tacrolimus ointment for atopic dermatitis. European Tacrolimus Multicenter Atopic Dermatitis Study Group.
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, doubleblind, 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.
authors.affiliation: Department of Dermatology at Heinrich Heine University, Düsseldorf, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Ruzicka
authors.forename: T
authors.initials: T
authors.lastname: Bieber
authors.forename: E
authors.initials: E
authors.lastname: Schöpf
authors.forename: A
authors.initials: A
authors.lastname: Rubins
authors.forename: A
authors.initials: A
authors.lastname: Dobozy
authors.forename: J D
authors.initials: JD
authors.lastname: Bos
authors.forename: S
authors.initials: S
authors.lastname: Jablonska
authors.forename: I
authors.initials: I
authors.lastname: Ahmed
authors.forename: K
authors.initials: K
authors.lastname: Thestrup-Pedersen
authors.forename: F
authors.initials: F
authors.lastname: Daniel
authors.forename: A
authors.initials: A
authors.lastname: Finzi
authors.forename: S
authors.initials: S
authors.lastname: Reitamo
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D009824:Ointments; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D009824:Ointments; D016559:Tacrolimus