title: Addition of pimecrolimus cream 1% to a topical corticosteroid treatment regimen in paediatric patients with severe atopic dermatitis: a randomized, double-blind trial.
abstract: BACKGROUND
  Pimecrolimus and topical corticosteroids (TCS) combination therapy may provide an alternative treatment for patients with severe atopic dermatitis (AD), with faster clearance of disease flares, consequently reducing the duration of TCS treatment.
  
  
  OBJECTIVE
  To assess the safety profile of pimecrolimus cream 1% combined with fluticasone versus fluticasone alone in paediatric patients with severe AD.
  
  
  METHODS
  Patients (n = 376) were randomized to a combination of pimecrolimus cream 1% with fluticasone or vehicle plus fluticasone for 4 weeks. The primary outcome measure was the frequency of clinically relevant pre-defined adverse events (AEs) associated with the topical use of corticosteroids in patients with severe AD.
  
  
  RESULTS
  Erythematous rash was the only AE, occurring more frequently in the combination group, while there were no noticeable differences in the frequency of other AEs of clinical interest between treatment groups. Efficacy variables were comparable between the two groups. A trend for greater time to relapse was observed for the combination of pimecrolimus cream 1% with fluticasone in patients who were clear at the end of treatment, with a marked improvement in facial AD.
  
  
  CONCLUSIONS
  In paediatric patients with severe AD the overall safety profile of pimecrolimus cream 1% combined with fluticasone was similar to that of fluticasone alone.
authors.affiliation: Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Dermatologie Dresden, Dresden, Germany. meurer@rcs.urz.tu-dresden.de
authors.forename: Michael
authors.initials: M
authors.lastname: Meurer
authors.forename: Lawrence F
authors.initials: LF
authors.lastname: Eichenfield
authors.forename: Vincent
authors.initials: V
authors.lastname: Ho
authors.forename: Paul C
authors.initials: PC
authors.lastname: Potter
authors.forename: Thomas
authors.initials: T
authors.lastname: Werfel
authors.forename: Thomas
authors.initials: T
authors.lastname: Hultsch
mesh_terms: D000287:Administration, Topical; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use*; D003876:Dermatitis, Atopic / Q000175:diagnosis* / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D009824:Ointments / Q000627:therapeutic use; D018570:Risk Assessment; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000730:Androstadienes; D007166:Immunosuppressive Agents; D009824:Ointments; C117268:pimecrolimus; D000068298:Fluticasone; D016559:Tacrolimus