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

Abstract

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.

• Authors: Jeffrey L Sugarman, Lawrence Charles Parish
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 8 Issue 12 Pg. 1106-11 (Dec 2009) ISSN: 1545-9616 [Print] United States
• PMID: 20027938 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Androstadienes
• Ceramides
• Fatty Acids, Nonesterified
• Cholesterol
• Fluticasone

Topics

• Adolescent
• Androstadienes (adverse effects, therapeutic use)
• Ceramides (administration & dosage)
• Child
• Child, Preschool
• Cholesterol (administration & dosage)
• Dermatitis, Atopic (drug therapy)
• Fatty Acids, Nonesterified (administration & dosage)
• Female
• Fluticasone
• Humans
• Infant
• Male
• Single-Blind Method