Document Detail

Onset of action of pimecrolimus cream 1% in the treatment of atopic eczema in infants.
MedLine Citation:
PMID:  15536429     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: 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.
Roland Kaufmann; Regina Fölster-Holst; Peter Höger; Diamant Thaçi; Helena Löffler; Doris Staab; Matthias Bräutigam;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of allergy and clinical immunology     Volume:  114     ISSN:  0091-6749     ISO Abbreviation:  J. Allergy Clin. Immunol.     Publication Date:  2004 Nov 
Date Detail:
Created Date:  2004-11-10     Completed Date:  2004-12-09     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  1275002     Medline TA:  J Allergy Clin Immunol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1183-8     Citation Subset:  AIM; IM    
Department of Dermatology and Venereology, Johann Wolfgang Goethe-Universität, Hautklinik, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany.
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MeSH Terms
Dermatitis, Atopic / drug therapy*
Double-Blind Method
Follow-Up Studies
Tacrolimus / administration & dosage*,  adverse effects,  analogs & derivatives*
Reg. No./Substance:
0/Ointments; 0/pimecrolimus; 109581-93-3/Tacrolimus

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