A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis.
J Am Acad Dermatol
; 51(4): 515-25, 2004 Oct.
Article
en En
| MEDLINE
| ID: mdl-15389185
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.CONCLUSION:
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.
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Bases de datos:
MEDLINE
Asunto principal:
Tacrolimus
/
Dermatitis Atópica
/
Fármacos Dermatológicos
Tipo de estudio:
Clinical_trials
/
Etiology_studies
Límite:
Adolescent
/
Child
/
Child, preschool
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
J Am Acad Dermatol
Año:
2004
Tipo del documento:
Article
País de afiliación:
Estados Unidos