Thanks to Beth, here is some more information about a class of FDA Approved “Medical Device” creams. This class of creams are prescription only, contain no active molecules and are approved for sale to treat medical conditions under via the provisions of Class 1 510(k).
It does seem unusual that these creams still require a prescription even though they don’t have any ingredients that are officially `active’.
Why Barrier Creams?
I have never seen any trials that directly link the use of barrier creams with a reduction in rosacea symptoms. Nonetheless we do know that a gentle skincare regime is good for rosacea. Additionally for those who suffer from environmental triggers, and indeed for any with an impaired barrier function, a topical to restore the protective functions of the skin is an interesting prospect.
Here are some comments from Leon H. Kircik, MD., printed in Skin & Allergy News.
A supplement to Skin & Allergy News and supported by Ferndale Laboratories.
Nonsteroidal Agents for Skin Barrier Repair
Three 510(k) medical device creams have become available over the past several years that are cleared by the FDA for the treatment of atopic dermatitis. This medical device designation means that there is no active drug in the formulation. These products— Atopiclair, Eletone, and MimyX—are also known as barrier creams because they hydrate the skin, help restore damaged stratum corneum, and improve the integrity of the epidermal barrier. Another product, EpiCeram Cream, also is FDA-approved for the treatment of atopic dermatitis but currently is not marketed
Atopiclair contains 2% glycyrrhetinic acid in a hydrolipid base. Atopiclair contains a nut oil and should be used with caution in patients with a known allergy to nuts or nut oil. However, the nut oil in Atopiclair is shea butter, derived from the nut of a North African tree (Butyropermum parkii). The shea nut is not a legume, and Atopiclair contains no peanut oil or peanut extracts. MimyX contains ingredients that mimic natural lipids and squalane, which are components of the stratum corneum. The main ingredient in MimyX is N-palmitoylethanolamine (more commonly referred to as PEA); PEA is a naturally occurring essential fatty acid with anti-inflammatory properties that usually is deficient in patients with atopic dermatitis.
Eletone is unique among the barrier creams because it contains 70% oil dispersed in 30% water yet maintains the consistency and feel of a cream. (Most creams contain 30% oil in 70% water; most ointments contain 30% water dispersed in 70% oil). This is possible through the use of Hydrolipid “reverse emulsion” technology. As a result of this proportion of lipids and water, Eletone provides the advantages of ointments (occlusion and maximal barrier protection) without the disadvantages: many patients object to the cosmetic appearance and feel of “greasiness” and fail to comply with regimens involving ointments.
A number of inflammatory dermatologic conditions adversely affect the dermal barrier; among the most common is atopic dermatitis. The nonsteroidal barrier creams discussed here are welcome additions to the roster of treatments that may be useful as adjuncts to topical corticosteroid therapy during acute flares and as long-term maintenance during periods of disease remission. Their safety profile is excellent: there is no pregnancy category, and there are no age, application-site, or duration of treatment restrictions on their use.
Ferndale Laboratories are the makers of Eletone. Their web site has been down for a while now though.
Eletone should not be confused with Elecon which is a steroid cream.
It is interesting to read that Eletone has such a high dispersion of oil in water, yet is not greasy. This will definitely help people who would like to try these sorts of barrier creams but greasy products are out of the question.
More Medical Device Creams
Another Class 1 501(k) Medical Device Cream that might be interesting is Kelo-Cote. Kelo-Cote contains silicone compounds such as polysiloxane and silicone dioxide. This is promoted as a scar treatment and is said to have been shown to flatten, soften, smooth and relieve the itching and discoloration of scars.
Even More Barrier Cream Options
If you would like to try a different barrier cream then something like the new Cetaphil RestoraDERM might be worth a try. This has been formulated as a skin restoring body moisturizer for itchy dry skin.
This product is more marketed towards Eczema sufferers but has received some good reviews from rosacea sufferers.
Some Good Eczema Advice
I thought this following advice was pretty reasonable: you can use these non-steroidal creams to help you wean off the harsher topicals like Protopic and Elidel that have side effects and may not be suitable long term.
- Apply Protopic Ointment twice daily to all affected areas. Avoid the sun.
- Apply Elidel Cream twice daily to all affected areas. Avoid the sun.
- Apply Atopiclair twice daily to all affected areas. Avoid if you have a nut/peanut allergy.
- Apply Mimyx Cream twice daily to all affected areas.
- Apply Eletone Cream twice daily to all affected areas.
- Apply Epiceram twice daily to all affected areas.
As your eczema or rash improves, decrease use of cortisone products and/or Elidel/Protopic and try to use Atopiclair, Mimyx, Eletone Cream, or Epiceram. As you improve further, eliminate the Atopiclair, Mimyx, Eletone, or Epiceram and just lubricate your skin instead.
Protopic ointment and Elidel Cream have Black Box Warnings placed on them by the FDA. They report plausible cause of skin cancer, lymphoma, and other cancers.
As listed above, EpiCeram Cream is another Skin Barrier Treatment marketed as a Skin Barrier Emulsion.
EpiCeram is made by Promius Pharma, who also make Promiseb Topical Cream. EpiCream is apparently covered by Patent 5,643,899 Lipids for epidermal moisturization and repair of barrier function. This patent suggests that the important parts of such preparations are cholesterol and acylceramide.
See the EpiCeram Prescribing Information for more information.
Barrier Creams for Rosacea Sufferers?
So what do you think?
Would you try a barrier cream to help with your rosacea, or seborrheic dermatitis or extra dry skin? Please let us know how you get on if you do.