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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.

Links

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Authors+Show Affiliations

Kempers S
Minnesota Clinical Study Center, Fridley, MN 55432-3133, USA. Sekemps@aol.com
Boguniewicz M
No affiliation info available
Carter E
No affiliation info available
Jarratt M
No affiliation info available
Pariser D
No affiliation info available
Stewart D
No affiliation info available
Stiller M
No affiliation info available
Tschen E
No affiliation info available
Chon K
No affiliation info available
Wisseh S
No affiliation info available
Abrams B
No affiliation info available

MeSH

AdolescentChildChild, PreschoolDermatitis, AtopicDermatitis, IrritantDermatologic AgentsDrug Administration ScheduleDrug CombinationsErythemaFemaleHumansMaleOintmentsPatient SatisfactionPruritusTacrolimus

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 -