Blood concentrations, tolerability and efficacy of pimecrolimus cream 1% in Japanese infants and children with atopic dermatitis

Lawrence F. Eichenfield, Vincent Ho, Janice Matsunaga, Patricia Leclerc, Carle Paul, Jon Hanifin

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Pimecrolimus cream 1% is a topical calcineurin inhibitor for the treatment of atopic dermatitis. Minimal systemic exposure to pimecrolimus has been previously observed in Caucasian pediatric patients treated with the cream twice daily for up to 1 year. The objective of this open-label, non-comparative, multicenter study was to assess the systemic exposure, tolerability and efficacy of pimecrolimus cream 1% when used twice daily for 3 weeks in pediatric patients of Japanese background. The patient cohort consisted of 17 Japanese infants and children (age range, 3.6 months to 11.6 years) with atopic dermatitis of at least mild severity affecting ≥10% of the total body surface area (range, 10-48%). Pimecrolimus cream 1% was applied twice daily for 3 weeks. Blood levels of pimecrolimus were determined on days 1, 10 and 22. Safety and tolerability were evaluated by monitoring adverse events, laboratory parameters, physical condition and vital signs. Efficacy parameters included the Eczema Area and Severity Index, the Investigators' Global Assessment and the pruritus score. The median exposure to pimecrolimus cream 1% was 22 treatment days (range, 9-29 treatment days). Pimecrolimus blood concentrations were

Original languageEnglish (US)
Pages (from-to)231-236
Number of pages6
JournalJournal of Dermatology
Volume34
Issue number4
DOIs
StatePublished - Apr 2007

Fingerprint

Atopic Dermatitis
Pediatrics
Vital Signs
Body Surface Area
Eczema
Pruritus
pimecrolimus
Multicenter Studies
Therapeutics
Research Personnel
Safety

Keywords

  • Atopic dermatitis
  • Eczema
  • Elidel
  • Pimecrolimus cream 1%
  • SDZ ASM 981

ASJC Scopus subject areas

  • Dermatology

Cite this

Blood concentrations, tolerability and efficacy of pimecrolimus cream 1% in Japanese infants and children with atopic dermatitis. / Eichenfield, Lawrence F.; Ho, Vincent; Matsunaga, Janice; Leclerc, Patricia; Paul, Carle; Hanifin, Jon.

In: Journal of Dermatology, Vol. 34, No. 4, 04.2007, p. 231-236.

Research output: Contribution to journalArticle

Eichenfield, Lawrence F. ; Ho, Vincent ; Matsunaga, Janice ; Leclerc, Patricia ; Paul, Carle ; Hanifin, Jon. / Blood concentrations, tolerability and efficacy of pimecrolimus cream 1% in Japanese infants and children with atopic dermatitis. In: Journal of Dermatology. 2007 ; Vol. 34, No. 4. pp. 231-236.
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