Journal
DERMATOLOGY
Volume 221, Issue 4, Pages 342-351Publisher
KARGER
DOI: 10.1159/000320125
Keywords
Atopic dermatitis; Calcineurin inhibitor; Occlusion; Pharmacokinetics; Pimecrolimus; Safety; skin permeation; Systemic exposure; Topical administration
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Funding
- Novartis Pharma AG
- Novartis
- Astellas Pharma
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Aim: To evaluate the systemic exposure of pimecrolimus cream 1% applied under occlusion in atopic dermatitis (AD) patients. Methods: A noncomparative, open-label study conducted in 3 groups of moderate to severe AD patients: A (adults, n = 9), B (adolescents, n = 4) and C (children, n = 6). Pimecrolimus cream 1% was applied twice daily for 8.5 days with overnight occlusion in patients with investigator's global assessment scores of >= 3 and AD involving at least 30% of their body surface area. Pimecrolimus blood concentrations were analyzed. Results: The highest pimecrolimus blood concentrations observed in adults, adolescents and children were 1.84, 0.55 and 1.29 ng/ml, respectively. Pimecrolimus blood concentrations and affected body surface area showed no apparent correlation. Conclusion: No measurable differences were found in pimecrolimus blood concentrations, efficacy and safety profile when pimecrolimus cream 1% was applied under occlusion versus application without occlusion. These findings reflect the high lipophilic properties of pimecrolimus. Copyright (C) 2010 S. Karger AG, Basel
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