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


CONCLUSIONS
The ceramide-dominant, physiological-lipid based formulation could represent an effective stand-alone or ancillary therapy for many pediatric patients with AD.
Sugarman
Jeffrey L
JL
Department of Dermatology, University of California, San Francisco, CA, USA. pediderm@yahoo.com
Parish
Lawrence Charles
LC
D000293:Adolescent; D000730:Androstadienes / Q000009:adverse effects / Q000627:therapeutic use; D002518:Ceramides / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D002784:Cholesterol / Q000008:administration & dosage*; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D005230:Fatty Acids, Nonesterified / Q000008:administration & dosage*; D005260:Female; D000068298:Fluticasone; D006801:Humans; D007223:Infant; D008297:Male; D016037:Single-Blind Method
D000730:Androstadienes; D002518:Ceramides; D005230:Fatty Acids, Nonesterified; D002784:Cholesterol; D000068298:Fluticasone