FLUTICASONE PROPIONATE 0.05-PERCENT CREAM IN THE TREATMENT OF ATOPIC ECZEMA - A MULTICENTER STUDY COMPARING ONCE-DAILY TREATMENT AND ONCE-DAILY VEHICLE CREAM APPLICATION VERSUS TWICE-DAILY TREATMENT

The aim of this study was to compare the efficacy and safety of once-daily with twice-daily application of a 0.05% cream formulation of fluticasone propionate in the treatment of atopic eczema in adults and children. Two hundred and seventy patients with moderate to severe atopic eczema were enrolled in the study, and randomized to receive either once-daily or twice-daily fluticasone propionate 0.05% cream for 4 weeks, Patients randomized to the once-daily group also received the vehicle cream to ensure that the study remained blinded, The clinical response of a preselected target area of affected skin was assessed by investigators at weekly intervals, and compared with the baseline. Analysis of the investigators' overall assessment of the response of the target area for both the 'intent-to-treat' population and the per protocol population showed that 79-85% of patients were judged a clinical success, For both populations, there was no statistically significant difference between the response to once-daily and twice-daily active treatment (intent-to-treat; P = 0.35; 95% confidence interval for difference -14.2 to +5.0 percentage points: per protocol; P = 0.42; 95% confidence interval for difference -14.7 to +6.2 percentage points.) The improvement in the signs and symptoms was judged a success in 95-97% of patients, There was an equal reduction in severity scores for disease activity in both groups, and the speed of symptom relief was similar. This study shows that a regimen of once-daily application of fluticasone propionate 0.05% cream and once-daily vehicle cream is equivalent in efficacy and safety to twice-daily treatment with fluticasone propionate 0.05% cream when used over a 4-week treatment period in patients with moderate to severe atopic eczema.