Efficacy and safety of pimecrolimus cream 1% in mild-to-moderate chronic hand dermatitis: a randomized, double-blind trial.
Author(s): Hordinsky M, Fleischer A, Rivers JK, Poulin Y, Belsito D, Hultsch T
Affiliation(s): University of Minnesota School of Medicine, Department of Dermatology, Minneapolis, MN 55455, USA. firstname.lastname@example.org
Publication date & source: 2010-08, Dermatology., 221(1):71-7. Epub 2010 Jun 8.
Publication type: Research Support, Non-U.S. Gov't
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. Copyright 2010 S. Karger AG, Basel.