Onset of action of pimecrolimus cream 1% in the treatment of atopic eczema in infants

Roland Kaufmann, Regina Fölster-Holst, Peter Höger, Diamant Thaçi, Helena Löffler, Doris Staab, Matthias Bräutigam

53 Citations (Scopus)


Data on the efficacy of pimecrolimus cream 1% within the first days of treatment are scarce, as in previous studies, the first postbaseline assessment was performed only after 1 week. We sought to investigate the onset of action of pimecrolimus cream 1% in infants with mild to very severe atopic eczema. We used pimecrolimus cream 1% (n = 129) or vehicle cream (n = 66) administered in a double-blind manner for 4 weeks and then open-label pimecrolimus cream 1% for 12 weeks, with a 4-week follow-up period. Pimecrolimus cream 1% reduced the mean Eczema Area and Severity Index at 4 weeks by 71.5% compared with an increase of 19.4% with vehicle (P <. 001). The reduction in the Eczema Area and Severity Index with pimecrolimus cream 1% was significant at day 4 (38.5% vs 17.6% increase with vehicle). Significant improvements in caregivers' assessments of pruritus and sleep loss were observed with pimecrolimus cream 1% by day 2 (P <. 03) and day 3 (P =. 002), respectively, compared with vehicle. Responses to pimecrolimus cream 1% were sustained during the open-label phase, and pimecrolimus cream 1% was well tolerated. Symptoms of atopic eczema returned gradually after discontinuation. Pimecrolimus cream 1% was well tolerated and effective in patients with mild to very severe atopic eczema, with rapid onset of action and no disease rebound after discontinuation.

Original languageEnglish
JournalJournal of Allergy and Clinical Immunology
Issue number5
Pages (from-to)1183-1188
Number of pages6
Publication statusPublished - 11.2004

Research Areas and Centers

  • Academic Focus: Center for Infection and Inflammation Research (ZIEL)


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