title: Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis.
abstract: BACKGROUND
  Vehicle-controlled studies have demonstrated the efficacy and safety of tacrolimus ointment in the treatment of patients with atopic dermatitis (AD).
  
  
  OBJECTIVE
  This study was undertaken to compare 0.03% and 0.1% tacrolimus ointment with 1% hydrocortisone acetate ointment in children 2 to 15 years of age with moderate-to-severe AD.
  
  
  METHODS
  Treatment was twice daily to affected areas for 3 weeks in this multicenter, randomized, double-blind, parallel-group study. The primary endpoint was the modified eczema area and severity index (mEASI) mean area under the curve (mAUC) as a percentage of baseline.
  
  
  RESULTS
  Five hundred sixty patients were randomized and received at least one application of ointment. Discontinuations included 21 of 189 patients from the 0.03% tacrolimus group, 13 of 186 patients from the 0.1% tacrolimus group, and 20 of 185 patients from the hydrocortisone acetate group. The median mEASI mAUC as a percentage of baseline showed 0.03% and 0.1% tacrolimus to be significantly more effective than 1% hydrocortisone acetate (P <.001) and 0.1% tacrolimus to be more effective than 0.03% tacrolimus (P =.006). The mEASI mAUC as a percentage of baseline was 44.8%, 39.8%, and 64.0% for patients who received 0.03% tacrolimus, 0.1% tacrolimus, and 1% hydrocortisone acetate, respectively. Transient skin burning was the only adverse event to show a higher incidence in the tacrolimus treatment groups than in the hydrocortisone acetate group (P <.05). Laboratory parameters showed no treatment differences and no marked changes over time.
  
  
  CONCLUSIONS
  Tacrolimus, 0.03% and 0.1%, was significantly more effective than 1% hydrocortisone acetate and 0.1% tacrolimus was more effective than 0.03% tacrolimus in the treatment of moderate-to-severe AD in children. No safety concerns were identified.
authors.affiliation: Department of Dermatology, Hospital for Skin and Allergic Diseases, University of Helsinki, Helsinki, Finland.
authors.forename: Sakari
authors.initials: S
authors.lastname: Reitamo
authors.forename: Edwin J M
authors.initials: EJ
authors.lastname: Van Leent
authors.forename: Vincent
authors.initials: V
authors.lastname: Ho
authors.forename: John
authors.initials: J
authors.lastname: Harper
authors.forename: Thomas
authors.initials: T
authors.lastname: Ruzicka
authors.forename: Kirsti
authors.initials: K
authors.lastname: Kalimo
authors.forename: Frédéric
authors.initials: F
authors.lastname: Cambazard
authors.forename: Malcolm
authors.initials: M
authors.lastname: Rustin
authors.forename: Alain
authors.initials: A
authors.lastname: Taïeb
authors.forename: David
authors.initials: D
authors.lastname: Gratton
authors.forename: Daniel
authors.initials: D
authors.lastname: Sauder
authors.forename: Graham
authors.initials: G
authors.lastname: Sharpe
authors.forename: Catherine
authors.initials: C
authors.lastname: Smith
authors.forename: Michael
authors.initials: M
authors.lastname: Jünger
authors.forename: Yves
authors.initials: Y
authors.lastname: de Prost
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; C021650:hydrocortisone acetate; D006854:Hydrocortisone; D016559:Tacrolimus