Efficacy and Safety of Pimecrolimus Cream 1% in Mild-to-Moderate Chronic Hand Dermatitis: A Randomized, Double-Blind Trial

Abstract

Background: Chronic hand dermatitis is common and difficult to treat. Objective: Our aim was to assess the efficacy of pimecrolimus cream 1% in mild-to-moderate chronic hand dermatitis. Methods: Adult patients (n = 652) were randomized to pimecrolimus 1% or vehicle cream twice daily with overnight occlusion for 6 weeks, followed by a 6-week open-label pimecrolimus treatment. Primary efficacy was 5-point Investigators’ Global Assessment of prospectively selected ‘target hand’ as treatment success (Investigators’ Global Assessment 0 or 1) and treatment failure. Pruritus relief was also assessed. Results: Following double-blind phase treatment, target hand treatment success was achieved in 29.8 and 23.2% of the patients in the pimecrolimus and vehicle groups, respectively (p = 0.057). The proportion of patients experiencing pruritus relief was significantly higher in the pimecrolimus group compared to the vehicle group at all time points throughout the double-blind phase. Conclusion: The groups were comparable with respect to treating disease signs. Pruritus relief, however, was significantly greater in the pimecrolimus group.