Anyway, today we're going to be talking about EpiCeram controlled release, skin barrier emulsion and Leon, this brings back memories of years ago because we did a lot of work on this. We wrote some publications, evaluated data, were involved with some clinical studies. But to bring everybody up to date, EpiCeram control release skin barrier emulsion is really a standard for how a barrier formulations were put together. It's fragrance free, it's not a corticosteroid, it contains ceramide. We'll talk a little bit about a ceremide called the pseudo ceramide, which it does contain, which many other formulations contain pseudo ceramides. Importantly, the fatty acids specifically conjugated linoleic acid, and it also contains palmitic acid and those are very important physiologic lipids. And then cholesterol balanced to simulate the intercellular lipid membrane of the skin barrier of the stratum corneum. 3-1-1 ratios, ceramides to fatty acids to cholesterol. Importantly, a couple of other things is in purified water, it has phenoxyethanol as its preservative, which has a very low rate of irritancy and contact dermatitis. Some other components, like glycerin, which is obviously important for humectancy, dimethicone, are very important emollient that's very popular for emollientcy. So it's formulated extremely well, but we're going to be focusing on what its indication is. And Leon, can you give us a little bit of background before we do that about the type of product this is and how these got introduced initially? 

So couple of important points, as you know the 510(k) device, and when we go back to the history of 510(k) device approvals, it actually goes back to the very first product that came to US, which is not in the market anymore as far as I know, and it was a trolamine based product that was approved for radiation dermatitis in France. And then it came back to US, with that same indication, ironically. However, in dermatology, you know, we are keen on atopic derm and skin barrier functions, so we always use those products for atopic dermatitis, but the history goes back to radiation dermatitis. 

And that brings us to the indications, which for EpiCeram specifically, to treat dry skin conditions, which is a broad indication, right. And also manage really and relieve symptoms. It's not, you know, approved for a specific disease state. It's to manage symptoms associated with various dermatoses. That gives you a lot of leeway. It does mention atopic dermatitis, irritant contact dermatitis, and radiation dermatitis as examples, but it's primarily to relieve the symptoms like burning and itching, so that gives you a lot of leeway in where you can use this particular formulation, correct? 

Yes, and Jim, one thing to mention in addition to all those indications. And you mentioned the ingredients of the product really in a very elaborated way. But one thing we have to emphasize on the multi-celled release option, right? It is a patented time release system that no other product in this field that I know of it has. It's the multi-cell neolipids are release system that gives 24 hour barrier repair benefits that is very, very important with just one application a day. And the multi-celled system is a multi-component, multi-compartment microencapsulation that allows the release of different ingredients that you mentioned, including the conjugated linoleic acid, the pseudo ceramide and the cholesterol in a timely fashion, little by little. And that when the emulsion is dropped on the skin, the initial other 30 micron-nanosphere shell dissolves and it helps the release of the submicron spheres, infused with the CLA and the release of the content slowly over time. So basically it's a very practical way of getting the benefit of the product over 24 hours with one application only. 

So the thing that's really important that you said, it's actually a 2 sphere system. There's that outer shell sphere. And then once that basically dissolves away, there are those submicron spheres that contain the cholesterol, contain the conjugated linoleic acid, which is important to encapsulate. Because when those fatty acids, like the CLA and the palmitic acid get released and they get oxidized, there can be odor and this system prevents that, where generic versions I've heard people complain about the odor. Well, make sure the patients getting the right one cause this does not have any malodor that people have noticed with it. You know, the palmitic acid and the CLA they reduce transepidermal water loss. We know, this formulation certainly does. The CLA also increases ceramide synthesis and what I found in literature, there has been CLA conjugated linoleic acid used post fractionated laser procedures that have significant improvement in reducing inflammation, irritation and swelling. So the conjugated linoleic acid is a very important part of this formulation, but the bottom line is it's simulating the natural intercellular lipid membrane, as you mentioned. I do want to point out something that you did mention. The label does say twice daily application, but the data does show that once daily provides that moisturization over 24 hours. So that's a very important point. Do you have any final comments you want to make about this particular formulation? I think we need to talk a little bit about radiation dermatitis because we know that when patients utilize an alkaline soap or they go from a the humid climate like where you are in Louisville out, you get off the plane in Las Vegas or in Scottsdale you can immediately feel the transepidermal water loss in the skin getting dry and symptomatic. With ultraviolet light exposure chronic photodamage, it's slower, you know, but there is barrier impairment with increased transepidermal water loss. With radiation dermatitis, the literature shows that you have barrier impairment. You gotta remember the burn if you will, is deeper. It's deeper in in the dermis and secondarily it affects more superficially with transepidermal water loss. You have transepidermal water loss and barrier impairment much earlier than you see the radiation dermatitis. Radiation dermatitis visibly can take 10 days to three weeks, but the barrier impairment is earlier, so it makes sense to me, and I'd love to you for you to give a final comment on it, that you start treating that radiation dermatitis early on. You don't wait to see the problem in order to try to help that patient. 

I think absolutely you brought up a very important point that unfortunately it takes about a good 10 to 11 days for the radiation dermatitis patients to see this clinical signs of that dryness of the itching and burning, all the clinical signs of the epidermal barrier dysfunction, unlike in atopic dermatitis, where we deal with in our practices, right? So it is important for these patients to start the treatment early on from get go, maybe not even day one, but even before to prepare the skin because the other thing is in addition to the radiation, they also have to deal with the daily challenges of washing just with the water, tap water, which is the pH is neutral, right? So the formulation here is pH of five, acidic pH is very important to keep the pH of the skin on top of what's going on with the radiation, right? With the salt, the cleanser, the tap water. You're looking at the pages of above acidic numbers, and that's really important. 

Yeah, the acid mantle, the skin. That's extremely important. We often forget about pH. Maintaining consistent with the skins natural pH has everything to do with epidermal barrier function, right and the wrong pH can just rail everything else we're trying to do so all of that is extremely important. We want to stay ahead of the problem. One caveat with radiation dermatitis that the package insert does state is it they recommend not to have the patient apply the EpiCeram within 4 hours before the radiation treatment, but to use it after. So I think that's an important thing. And also you brought up a great point. That's why I love talking to you, Leon. You're brilliant. That the other aspects, the gentle cleanser, the you know, in addition to these products, doing everything we can to help the skin barrier is going to help the patient. So thank you, Leon, for joining us today, and I hope this helps listeners understand this product and this disease state better for their patients. 

Thank you for the invite. Thank you. For including me. Bye bye.