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

AbstractBACKGROUND:
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.
OBJECTIVE:
We sought to investigate the onset of action of pimecrolimus cream 1% in infants with mild to very severe atopic eczema.
METHODS:
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.
RESULTS:
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.
CONCLUSION:
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.
AuthorsRoland Kaufmann, Regina Fölster-Holst, Peter Höger, Diamant Thaçi, Helena Löffler, Doris Staab, Matthias Bräutigam, CASM981CDE04-Study Group
JournalThe Journal of allergy and clinical immunology (J Allergy Clin Immunol) Vol. 114 Issue 5 Pg. 1183-8 (Nov 2004) ISSN: 0091-6749 [Print] United States
PMID15536429 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Ointments
  • pimecrolimus
  • Tacrolimus
Topics
  • Dermatitis, Atopic (drug therapy)
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Infant
  • Male
  • Ointments
  • Tacrolimus (administration & dosage, adverse effects, analogs & derivatives)

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