title: Addition of topical pimecrolimus to once-daily mid-potent steroid confers no short-term therapeutic benefit in the treatment of severe atopic dermatitis; a randomized controlled trial.
abstract: BACKGROUND
  Combination therapy with pimecrolimus cream 1%, a topical calcineurin inhibitor (TCI), and fluticasone propionate cream 0.05% (FP), a mid-potency topical corticosteroid, may have a synergistic effect for treatment of atopic dermatitis (AD) because their mechanism of action differs.
  
  
  OBJECTIVE
  To assess the efficacy of concomitant pimecrolimus twice daily/FP once daily vs. vehicle twice daily/FP once daily in patients with severe AD.
  
  
  METHODS
  An exploratory, 2-week, double-blind, randomized, within-patient study was conducted (n = 45). Two target areas of similar severity, size and location were assessed. Assessments included the modified Eczema Area and Severity Index (0-12 scale) (primary variable), localized investigator global assessment (0-4 scale) and Patients' Self-Assessment of Disease Severity (0-4 scale).
  
  
  RESULTS
  Data for all variables were similar for the TCI/FP and vehicle/FP treatments.
  
  
  CONCLUSIONS
  The efficacy observed for treatment of severe AD flares with this TCI/FP combination regimen was equivalent to that of vehicle/FP.
authors.affiliation: Division of Allergy and Immunology, Children's Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA, USA. Spergel@email.chop.edu
authors.forename: J M
authors.initials: JM
authors.lastname: Spergel
authors.forename: M
authors.initials: M
authors.lastname: Boguniewicz
authors.forename: A S
authors.initials: AS
authors.lastname: Paller
authors.forename: A A
authors.initials: AA
authors.lastname: Hebert
authors.forename: P R
authors.initials: PR
authors.lastname: Gallagher
authors.forename: C
authors.initials: C
authors.lastname: McCormick
authors.forename: A
authors.initials: A
authors.lastname: Parneix-Spake
authors.forename: T
authors.initials: T
authors.lastname: Hultsch
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D003879:Dermatologic Agents; C117268:pimecrolimus; D000068298:Fluticasone; D016559:Tacrolimus