title: A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis.
abstract: OBJECTIVE
  To evaluate pimecrolimus cream 1% and tacrolimus ointment 0.03% in pediatric patients with moderate atopic dermatitis (AD).
  
  
  METHODS
  141 patients (aged 2-17 years) were randomized to treatment with pimecrolimus cream 1% (n=71) or tacrolimus ointment 0.03% (n=70) twice daily for 6 weeks.
  
  
  RESULTS
  At day 4, local, application-site reactions were less common and of shorter duration with pimecrolimus than with tacrolimus. Incidence of erythema/irritation was 8% (6/71) with pimecrolimus compared with 19% (13/70) with tacrolimus (P=.039). Fewer patients receiving pimecrolimus (0%, 0/6) experienced erythema/irritation lasting >30 minutes, compared with those receiving tacrolimus (85%, 11/13; P <.001). Fewer patients reported itching with pimecrolimus (8%; 6/71) than with tacrolimus (20%; 14/70; P=.073). Incidence of warmth, stinging, and burning was similar in both groups; however, reactions lasting >30 minutes were fewer with pimecrolimus (0%, 0/14) than with tacrolimus (67%, 8/12; P <.001). More patients receiving pimecrolimus rated ease of application as 'excellent' or 'very good', compared with tacrolimus (76% vs 59%, respectively; P <.020). Efficacy was similar in both groups at day 43. Both treatments were generally well tolerated with no unexpected adverse events.
  
  
  CONCLUSIONS
  Pimecrolimus cream 1% had better formulation attributes and local tolerability than tacrolimus ointment 0.03% while providing similar efficacy and overall safety in pediatric patients with moderate AD.
authors.affiliation: Minnesota Clinical Study Center, Fridley, MN 55432-3133, USA. Sekemps@aol.com
authors.forename: Steven
authors.initials: S
authors.lastname: Kempers
authors.forename: Mark
authors.initials: M
authors.lastname: Boguniewicz
authors.forename: Eric
authors.initials: E
authors.lastname: Carter
authors.forename: Michael
authors.initials: M
authors.lastname: Jarratt
authors.forename: David
authors.initials: D
authors.lastname: Pariser
authors.forename: Dan
authors.initials: D
authors.lastname: Stewart
authors.forename: Matt
authors.initials: M
authors.lastname: Stiller
authors.forename: Eduardo
authors.initials: E
authors.lastname: Tschen
authors.forename: Katie
authors.initials: K
authors.lastname: Chon
authors.forename: Steve
authors.initials: S
authors.lastname: Wisseh
authors.forename: Beatrice
authors.initials: B
authors.lastname: Abrams
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D017453:Dermatitis, Irritant / Q000209:etiology; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004890:Erythema / Q000139:chemically induced; D005260:Female; D006801:Humans; D008297:Male; D009824:Ointments; D017060:Patient Satisfaction; D011537:Pruritus / Q000139:chemically induced; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D009824:Ointments; C117268:pimecrolimus; D016559:Tacrolimus