Percutaneous Absorption of Pimecrolimus Is Not Increased in Patients with Moderate to Severe Atopic Dermatitis when Pimecrolimus Cream 1% Is Applied under Occlusion

Abstract

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.