Transcript
Ted Lain:
Let's jump into the study. So this is the study of sensitive skin regimen. And the sensitive skin regimen was we had a Cetaphil gentle skin cleanser, Cetaphil moisturizing cream. Both of those were used twice a day. And then we had the Cetaphil daily moisturizer with SPF35, which of course used once a day. And this was in addition to their prescription therapies, right guys? And the prescription therapies were pretty much all over the map. I mean, for us, we kind of talked about this a little bit. The vast majority were on topicals, weren't they?
Firas George Hougeir:
Correct. The vast majority were on topicals. You have to also know that when we're looking for what they are on treatment, multiple treatment also counted. And this is real life, real life study, phase four real life study. So very few of us have anybody who's on a biologic for psoriasis who also is not on topicals at the same time. So as you're counting the treatment or you’re mentioning the treatments, topicals always came up. So the big majority of our patients were on topicals whether they were on systemics or not.
Ted Lain:
Okay, gotcha. And they just had to have, I think it was a 3% BSA involvement. Is that right, Zoe?
Zoe Diana Draelos:
Right. And they had to have a target plaque that we followed. And we did non-invasive assessments and that had to be on an active lesion. So many people that are on biologics are completely clear, but in order to have an area to treat and identify as a target plaque, see, we had to have people that maybe were on more topical than injectable therapies just to be able to conduct the study. And that might be why the treatment skewed more to the topical than they did to the injectable.
Ted Lain:
Makes sense. Makes sense. OK. And so probably the majority are on topicals. They weren't completely clear. They had to have 3% body surface area. And just to remind everybody, 1% is the patient's handprint. That is 1% of their body. So three handprints worth of psoriasis at least. And they had to have a target lesion. So they had to have at least one plaque that was, what was it, two by two centimeters? That's usually the minimum requirement. Was that right?
Firas George Hougeir:
Yeah, correct.
Ted Lain:
OK. So they had to have at least a two by two centimeter plaque, which you guys followed over time and did the target lesion severity score. Which could you just remind us, Dr. Hougeir, the target lesion severity score, it's multiple metrics that we use to develop that score, right?
Firs George Hougeir:
Correct. Multiple metrics, we had to have six points, six points to start. And then we followed throughout the eight weeks, which when you think about it, it's quite short period of time for the results that we're getting.
Ted Lain:
Yeah. So it's like erythema, scaling, thickness, I believe. Isn't that right?
Score it and you add those scores together to get at least six. So not only did they have to have 3% BSA, they had to have a target lesion that met that requirement as well. And then Zoe, you guys did a lot of subjective assessments in terms of patient reported outcomes and PGA, physician global assessment, but there were also objective assessments using bioinstrumentation. Can you talk about what was used?
Zoe Diana Draelos:
Right. What we used is we basically tried to look at the lesion as technically as we possibly could. So we did moisture scores. That's a piece of equipment that has been developed by Courage + Khazaka that uses optical methods to assess skin moisturization because we wanted them to have an active plaque that was already under treatment, but then we wanted to show how much better you could make that plaque by intervening with skincare. So these people had been on a stable treatment regimen, topical corticosteroids, calcipotriene were some of the more commonly used topicals in the study. So these people had gotten this far. They had a lesion that had to qualify and they had 3% BSA, which in some ways you might say that would be kind of a failure of treatment perhaps a little bit.
And then we added skincare on top of that to show the additive benefit of that skincare. And part of the ways that we showed the additive benefit was through bioinstrumentation. So we looked at texture of the area, we assessed its appearance, but we also looked at the water in the skin and the water coming out of the skin, which are two important criteria. So medications when the lesion heals can induce improvement in skin hydration, but here we're trying to show that you can get more immediate improvement in skin hydration by using concomitant high quality skincare products.
Ted Lain:
It's worth noting that we're talking about a moisturizing cream, not an ointment. So this doesn't have a high degree of petrolatum, high content of petrolatum in it. It's not really sealing like a Vaseline would, for example, which patients don't like to use anyway. They're really difficult to use. So in terms of meeting patients' needs, I really liked the fact that this was a moisturizing cream and then a daily SPF. It just makes a lot of sense. And probably, as you said, Dr. Hougeir, this was an in-use real life study using products that patients probably like to use. I don't know what your experience was with the subjects, but I'm assuming they had no problem with these products.
Firas George Hougeir:
We only had one subject that felt burning, I think with the cleanser. This was actually my subject who is extremely sensitive to a lot of things. But other than that, nobody had any issues whatsoever across the board. And these are well-known regimens and well-known creams. The ceramide containing, they are one of our go-to creams that we give our patients. So it's not surprising because they have been studied extensively, but it was reassuring to see that in patients with psoriasis, the tolerance to these creams was similar to what we saw in patient without psoriasis.
Ted Lain:
Well, in terms of safety, as you said, I always like to start with safety, and Firas stole my thunder there, that's OK, Firas. So one subject dropped out due to a product-related adverse event, and as you said, a little bit of stinging. There were three who experienced a little bit of itching, stinging, or burning, but that resolves spontaneously with continued use. And honestly, that's not totally surprising either. Given the degree of barrier disruption in psoriasis, the skin is very raw and really open to some of these local skin reactions, so I'm not totally surprised, but wonderful that continued use tended to make these adverse events spontaneously improve. So overall, wonderful safety.
