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Published on: September 26, 2019
Efficacy of a lipid-based barrier repair formulation in moderate-to-severe pediatric atopic dermatitis
Jeffrey L Sugarman1, Lawrence Charles Parish
1Department of Dermatology, University of California, San Francisco, CA, USA. pediderm@yahoo.com
Insights
A ceramide-dominant lipid formulation (EpiCeram) effectively treated atopic dermatitis (AD) symptoms, including severity, itch, and sleep, comparable to a steroid cream by day 28.
Area of Science:
- Dermatology
- Biochemistry
- Clinical Trials
Background:
- Atopic dermatitis (AD) involves lipid-biochemical abnormalities.
- Restoring the skin barrier is crucial for AD management.
Purpose of the Study:
- To evaluate EpiCeram, a ceramide-dominant triple-lipid formulation, for atopic dermatitis (AD).
- To compare EpiCeram's efficacy against fluticasone propionate cream in AD patients.
Main Methods:
- A five-center, investigator-blinded, randomized trial involving 121 patients with moderate-to-severe AD.
- Primary outcomes included SCORAD scores, pruritus reduction, and sleep habit improvement.
- Comparison between EpiCeram and fluticasone cream over 28 days.
Main Results:
- EpiCeram significantly reduced disease severity, pruritus, and improved sleep at 14 and 28 days.
- While fluticasone showed faster initial improvement at 14 days, EpiCeram achieved comparable results by 28 days.
- No significant difference in SCORAD, pruritus, or sleep scores between EpiCeram and fluticasone by day 28.
Conclusions:
- Ceramide-dominant, physiological-lipid formulations like EpiCeram show promise for AD treatment.
- EpiCeram may serve as an effective standalone or adjunctive therapy for pediatric AD.
- This formulation offers a potential therapeutic option for managing 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.
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