Transcript
Ted Lain:
Listen, as we think about the adjuvant therapies and we expand, and we've touched on this a little bit, but you've kind of mentioned this, Zoe, that I think we can really focus on adjuvant skincare, not just for this inflammatory skin disease, but all inflammatory skin disease. And so for something like, we know that there are trials, certainly trials that you've run, Dr. Draelos, where there's been a run-in where you have a patient use gentle skincare, gentle moisturizer first, and then for example, an acne, add a retinoid to make sure that the regimen helps to improve the tolerability of the retinoid. Do you think for psoriasis it's necessary to do that, especially for some of these generics? Would a run-in help, you think, or is it even necessary?
Zoe Diana Draelos:
Well, the washout period is usually used in order to standardize skincare so that people who are using better emollients and people who are using worse emollients are in a level playing field. So what you might do in a psoriasis study, for example, is to have them wash out using a standardized cleanser moisturizer, and then you add the topical medication so that you're trying to eliminate the effect of skincare on the topical medication. But I would say that the skincare can actually improve the results of the topical medication because now you're going to put that topical medication on, then you're going to put the moisturizer on top, which is a semi-occlusive film. So that prevents rub off of your medication. And the other thing it does is because you get hydration of the stratum corneum, you're actually enhancing penetration because a hydrated stratum corneum is more permeable to drugs.
So I think one of the reasons why people use skincare like that is to see how much people improve during the washout period and then look at the additive benefit of using the topical medication. And when you design your study that way, you are optimizing your medication, one, by improving tolerability of the medication, like you mentioned with the retinoid, for example, and two, by mildly enhancing penetration and getting better drug delivery.
Ted Lain:
I love that. I had not thought about how hydration actually improves the penetration of the topical, and that's so important. Firas, it's kind of making me think we should start doing maybe a week or so of great skincare and then start adding in the topical, especially if it's a generic so that we ensure the barrier is in tip-top shape before we start the topical that way.
Firas George Hougeir:
I think it wouldn't hurt. It takes us a while anyway to get any patients to get anything from the pharmacy, including generics sometimes. So just getting them started right away and having the discussion about a skincare regimen for psoriasis patients at first visit is important, and that can only help. I absolutely agree.
Ted Lain:
Do you guys think that for the mild psoriasis patient, because sometimes we get those, the patient who's IgA of 2, relatively mild and they just have persistent plaques, would the results of this study make you think, maybe I can treat this completely with the OTC regimen and not have to prescribe anything? Am I reaching there or do you think that it's a possibility?
Zoe Diana Draelos:
I think it's a possibility. What I like to do is start the medication first along with the skincare, and then where they're doing better, withdraw the medication and keep them on maintenance skincare, or pulse the medication, Ted, so that maybe have them apply their medication every Monday, Wednesday, Friday, see how they do on that regimen, then do it twice a week, Monday, Thursday. So I think skincare can be very helpful in the maintenance phase of disease when you've achieved your desired endpoint, but now you have to maintain it. And I also think it can be sparing for steroids topically, calcipotriene topically, roflumilast topically. So I think that's a way of decreasing medication costs, making the medication last longer, but also not overtreating the patient. If skincare will do it, then they should receive skincare. But we don't talk a lot about the maintenance phase of disease. A lot of our attention is focused at acute treatment. But what happens when the patient's much better? How do you address that patient and how do you keep them better?
Firas George Hougeir:
We talk a lot about remittive effect these days. It's this buzzword that everybody's jumping on. At the end of the day, what it is is maintenance therapy or maintenance phase. The truth is our patients themselves will pulse, our patients themselves, once they get clear, especially when we're talking about mild, are not necessarily going to keep on adding the steroid on the spot that's clear. I think what Dr. Draelos just said is very important. We may be able to make it so that they are clear longer. This is not what we studied here, so we're not getting that from the study, but we may be able to keep them clear longer by maintaining the skin barrier and maintaining the adjuvant skin, which is skin treatment at the end of the day, but skincare over time. So that's actually a very good point that one can make and one should think of.
Ultimately, in a chronic disease that is going to come back, would keeping the skin barrier well maintained allow us to decrease the amount of active treatment or active ingredients, active drugs that we are using over the long term.
Zoe Diana Draelos:
I think skincare could even decrease the Koebner effect, which is so important in psoriasis where it occurs in areas of trauma. So perhaps by using skincare, you can reduce Koebnerization, which might result in the decrease of new lesions possibly. We didn't examine that in this particular study, but that's kind of a corollary I was just thinking about.
Ted Lain:
Yeah, I think this is brilliant. I mean, I think we're coming up with a brand new study here that probably should be done, which is we get these patients to clear and then as you mentioned, Zoe, we decrease application of the prescription topical but keep going and see how often they actually need the prescription topical and/or do a regimented twice a week and see how long we keep them clear with no flaring. I think that would be incredibly useful data for all of us to know because right now the remittive effect, as Dr. Hougeir was talking about, is really based on monotherapy. It's not like these patients in the long-term extension were using topical moisturizers. We certainly didn't give them moisturizers as part of that trial, and so they would've had to do it on their own. But if we did a trial where we gave them the moisturizer, then that would be great.
And again, the Cetaphil products that were used in this trial were the gentle skin cleanser, the very basic gentle skin cleanser, the Cetaphil moisturizing cream, the oldie but a goody, Cetaphil moisturizing cream, and then the daily moisturizer with SPF-35. So those are the most important ones to think about because those are the ones studied in this trial. But I don't know, Zoe, I think we've got a new trial there.
Zoe Diana Draelos:
Yeah. And I think a lot of skincare isn't used in phase two and three trials for drugs. And the reason is, is you're trying to separate the active from placebo, so you don't want to cloud anything. So if you really want to understand the effects of skincare, you're not going to find it in the FDA trials pretty much.
Ted Lain:
Yeah. Yeah.
Firas George Hougeir:
Something that's ...
Ted Lain:
Go ahead,
Firas George Hougeir:
No, I was going to add one point that it made me think of as you're talking about what you do long-term. I think most of these patients who were in my trial are still my patients, I still see them. And I can tell you that we don't give them any more Cetaphil. And by the way, this was blind technically, where they didn't know it was Cetaphil but everybody knew, but they're all still on it. They're buying their Cetaphil products and they're still using it. I kind of ask, "Are we still using it?" "Oh yeah, of course I am,” because they're convinced more than us because they've seen it when in a study it's different. But that tells you that the continuation of use of something that is helpful to these patients, and that might be why a lot of them are still on topicals, and that's it.
Ted Lain:
I really like trials, the results of which give us practical pearls, the ways that we can immediately incorporate that data into our practice. And I think this trial is one that opened my eyes, and it's something that I'm going to immediately incorporate into my practice, which is definitely having my psoriasis patients, especially those that I'm trying to maintain or treat on topicals to use a skincare regimen with these Cetaphil products. Because like you said, it sounds like the patients really liked them. They did very well, and these results speak for themselves. You can't argue with these results, especially since these were relatively resistant patients. As Zoe mentioned, they had to be relatively resistant to get in the trial because they had to have a certain amount of psoriasis. So it's so interesting.
