A randomized, open-label study to evaluate an intermittent dosing regimen of fluticasone propionate 0.05% cream in combination with regular emollient skin care in reducing the risk of relapse in pediatric patients with stabilized atopic dermatitis

Abstract

Background: Atopic dermatitis (AD) is a chronic, relapsing disease that requires maintenance treatment. This study examined the efficacy and safety of extended intermittent fluticasone propionate (FP) 0.05% cream, with emollient, vs emollient alone in children with AD.

Methods: Eligible patients (aged 1-17 years) received FP 0.05% cream twice daily for 4 weeks (acute phase) then randomized (1:1) to FP 0.05% cream once daily, twice per week plus emollient (Group A) or emollient alone (Group B) for up to 20 weeks (maintenance phase). Primary endpoint was time to first AD relapse. Safety was assessed throughout.

Results: This study enrolled 123 patients into the acute phase, of whom 107 entered the maintenance phase (Group A: 54; Group B; 53). Three patients (5.6%) in Group A and 30 (56.6%) in Group B experienced relapse (maintenance phase). Due to a low number of relapses, median time to first relapse could not be calculated for Group A; in Group B, it was 142 d (95% CI: 50, 150; p < .0001 vs Group A). FP and emollient were well tolerated.

Conclusions: In pediatric patients with stabilized AD, FP 0.05% cream plus emollient (for AD maintenance treatment) significantly reduced the risk of relapse vs emollient alone.

Keywords: Atopic dermatitis; emollient; fluticasone propionate 0.05% cream; relapse.