EpiCeram
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EpiCeram (EpiCeram Skin Barrier Emulsion) is a topical non-steroidal skin cream available and marketed within the United States. Based on the research of Peter M. Elias,[1] it is made up of a ratio of 3 parts ceramides, 1 part free fatty acids, and 1 part cholesterol with a controlled release mechanism. It is designed to treat atopic dermatitis,[2] a type of eczema.[3][medical citation needed]
EpiCeram was originally patented in June 1993, but its patent ultimately expired in July 2014.[4] As a result, generic equivalents of the 3:1:1 formula are available globally, including Ceradan Skin Barrier Repair Cream in Southeast Asia, and Dr. Different 311 Mosturizer in South Korea. A similar competitor product with an active delivery agent, CeraVe mosturizer, is available over-the-counter in North America.
Ceragenix obtained marketing clearance from the U.S. Food and Drug Administration in April 2006.[5] This prescription medical device[6][failed verification] works as a moisturizer and barrier cream. In the US, it requires prescription and was launched in October 2008 by Promius Pharma.[1] EpiCeram was acquired by PuraCap Pharmaceutical LLC in 2010. As of January 2025, EpiCeram is exclusively marketed in the United States.
EpiCeram obtained Health Canada medical device license in September 2009 and was distributed by Pediapharm. It was sold under prescription in Canada as a Class II medical device until October 2018, when Health Canada revoked EpiCeram's authorization for sale in Canada.[7]
References
[edit]- ^ a b "Home - Ceragenix". Archived from the original on 2010-04-13. Retrieved 2010-06-10.
- ^ Madaan, Arvind (October 2008). "Epiceram for the treatment of atopic dermatitis". Drugs of Today. 44 (10): 751–755. doi:10.1358/dot.2008.44.10.1276838. ISSN 1699-3993. PMID 19137128.
- ^ "EpiCeram US – Importance Of Healthy Lifestyle". EpiCeram US – Importance Of Healthy Lifestyle. 2020-08-17. Retrieved 2021-02-12.
- ^ US5643899A, Elias, Peter M.; Feingold, Kenneth R. & Thornfeldt, Carl R., "Lipids for epidermal moisturization and repair of barrier function", issued 1997-07-01
- ^ "April 2006 510(k) Clearances". Food and Drug Administration. Archived from the original on 2012-10-14. Retrieved 2019-12-16.
- ^ "Establishment Registration & Device Listing". Accessdata.fda.gov. Retrieved 2021-02-12.
- ^ "Archived device name search results". Health Canada (Medical Devices). Health Canada. 2025-01-25.
External links
[edit]- "Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis". U.S. National Institutes of Health. February 5, 2008. Entry at ClinicalTrials.gov
- "Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis". U.S. National Institutes of Health. February 5, 2008. Entry at ClinicalTrials.gov