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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. 2004 Oct; 51(4):515-25.JA

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.

Authors+Show Affiliations

Minnesota Clinical Study Center, Fridley, MN 55432-3133, USA. Sekemps@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15389185

Citation

Kempers, Steven, et al. "A Randomized Investigator-blinded Study Comparing Pimecrolimus Cream 1% With Tacrolimus Ointment 0.03% in the Treatment of Pediatric Patients With Moderate Atopic Dermatitis." Journal of the American Academy of Dermatology, vol. 51, no. 4, 2004, pp. 515-25.
Kempers S, Boguniewicz M, Carter E, et al. 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. 2004;51(4):515-25.
Kempers, S., Boguniewicz, M., Carter, E., Jarratt, M., Pariser, D., Stewart, D., Stiller, M., Tschen, E., Chon, K., Wisseh, S., & Abrams, B. (2004). A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis. Journal of the American Academy of Dermatology, 51(4), 515-25.
Kempers S, et al. 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. 2004;51(4):515-25. PubMed PMID: 15389185.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis. AU - Kempers,Steven, AU - Boguniewicz,Mark, AU - Carter,Eric, AU - Jarratt,Michael, AU - Pariser,David, AU - Stewart,Dan, AU - Stiller,Matt, AU - Tschen,Eduardo, AU - Chon,Katie, AU - Wisseh,Steve, AU - Abrams,Beatrice, PY - 2004/9/25/pubmed PY - 2005/4/12/medline PY - 2004/9/25/entrez SP - 515 EP - 25 JF - Journal of the American Academy of Dermatology JO - J Am Acad Dermatol VL - 51 IS - 4 N2 - 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. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/15389185/A_randomized_investigator_blinded_study_comparing_pimecrolimus_cream_1_with_tacrolimus_ointment_0_03_in_the_treatment_of_pediatric_patients_with_moderate_atopic_dermatitis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0190962204005511 DB - PRIME DP - Unbound Medicine ER -