A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis.
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.
Kempers
Steven
S
Minnesota Clinical Study Center, Fridley, MN 55432-3133, USA. Sekemps@aol.com
Boguniewicz
Mark
M
Carter
Eric
E
Jarratt
Michael
M
Pariser
David
D
Stewart
Dan
D
Stiller
Matt
M
Tschen
Eduardo
E
Chon
Katie
K
Wisseh
Steve
S
Abrams
Beatrice
B
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*
D003879:Dermatologic Agents; D004338:Drug Combinations; D009824:Ointments; C117268:pimecrolimus; D016559:Tacrolimus