A randomized, double-blind, vehicle-controlled, multicenter, parallel-group study evaluated the effects of topical pimecrolimus 0.1% cream in 73 patients with atopic dermatitis (AD) resistant to topical corticosteroids. The relationship between corticosteroid insensitivity, Staphylococcus aureus colonization and superantigen production in AD and the efficacy of pimecrolimus in corticosteroid-insensitive AD was explored. Clinical assessments comprised the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), pruritus assessment and patient's assessment score of disease control. The trial comprised a 2-week screening phase, a 6-week double-blind phase and a 12-week open label phase. Increased S. aureus counts significantly correlated with worsening of clinical scores (week 6 vs. baseline) whether assessed by IGA, pruritus or patient assessment. The presence of ...