Evaluating Clinical Use of a Ceramide-dominant, Physiologic Lipid-based Topical Emulsion for Atopic Dermatitis.

OBJECTIVES: The objective of this study was to evaluate the efficacy of a ceramide-dominant, physiologic lipid-based topical emulsion, inclusive of ceramides, cholesterol, and fatty acids in a 3:1:1 ratio, in the clinical practice setting in subjects with mild-to-moderate atopic dermatitis. The included subjects presented with a wide range of demographic characteristics thus building upon the results reported with this agent from an earlier clinical trial in atopic dermatitis subjects. In addition, the utility of this important treatment approach of starting with a product directed at epidermal barrier repair was explored.
METHODS: In a 50-center, open-label, interventional study, the ceramide-dominant, physiologic lipid barrier repair emulsion was evaluated for three weeks in 207 patients either as monotherapy or in combination with another atopic dermatitis treatment. Outcome measures included investigator global assessment, investigator and subject satisfaction, subject-perceived improvement in atopic dermatitis, pruritus severity, and two quality-of-life questions.
RESULTS: Overall, approximately half of the subjects achieved success with investigator global assessment (clear or almost clear investigator global assessment scores) after three weeks of treatment with the ceramide-dominant, physiologic lipid barrier repair emulsion as monotherapy or in combination with another treatment. A large proportion of subjects (75% of subjects) and investigators (for 77% of subjects) reported satisfaction after three weeks of treatment. Pruritus and quality of life improved during the study.
CONCLUSION: The ceramide-dominant, physiologic lipid-based product was shown to be an effective agent, with or without additional topical therapy, to provide good clinical efficacy and high levels of investigator and patient satisfaction for many patients with mild-to-moderate atopic dermatitis. The results of this study are consistent with results noted in a previous study of atopic dermatitis patients using this same barrier repair agent. The treatment approach of using a skin barrier repair cream as an integral and standard component of initial atopic dermatitis therapy, either as monotherapy or as a part of combination topical therapy, is supported by the outcomes observed in this study. This specific ceramide-dominant, physiologic lipid-based product may be used when initiating topical therapy for atopic dermatitis based on results from this and other studies.