Efficacy of a lipid-based barrier repair formulation in moderate-to-severe pediatric atopic dermatitis.

OBJECTIVES: The authors assessed the efficacy of a ceramide-dominant, triple-lipid barrier repair formulation (EpiCeram), which designed to correct the lipid-biochemical abnormalities in atopic dermatitis (AD) in comparison to fluticasone propionate cream. METHODS: In a five-center, investigator-blinded, randomized trial, EpiCeram was compared to fluticasone (Cutivate) cream in 121 patients with moderate-to-severe AD. Primary outcome measures were: 1) reduction in disease severity, assessed as SCORAD (Severity Scoring for Atopic Dermatitis) scores; 2) improvement in pruritus; and 3) improvements in sleep habits. RESULTS: EpiCeram reduced clinical disease severity, decreased pruritus and improved sleep habits both 14 and 28 days after initiation of therapy. Although the fluticasone-treated group showed significantly greater improvement at 14 days, SCORAD, pruritus and sleep habit scores for EpiCeram did not differ significantly from the fluticasone-treated group by 28 days. CONCLUSION: The ceramide-dominant, physiological-lipid based formulation could represent an effective stand-alone or ancillary therapy for many pediatric patients with AD.