Linda Stein Gold, MD

Experts explore the challenges of multi-product topical treatment algorithms for seborrheic dermatitis (SD).

Simplifying Treatment Regimens for Patients With SD

 When we go back and look at the clinical trial data and look at the areas that were treated, for the majority of patients, they were treating the scalp, but a lot of patients were treating the face and even the eyelids. So, James, when somebody has seborrheic dermatitis and it’s kind of creeping down on the face and it’s the glabella area and it’s the eyebrows and it’s kind of the whole central face [that] starts to get involved, in the past, what have you done if it’s in that periocular area?

 It’s a challenge, Linda, because we like to use topical cortical steroids as kind of a quick treatment, but we also know using steroids around the eyes can be getting to tiger territory, right? So glaucoma, cataracts, increased absorption, and so we have to be very judicious with using steroids in those areas. Topical calcineurin inhibitors has already been set. It burns, it stings, especially in those areas, and I found that topical azoles just don’t work quite that well either, so it’s great that we have a foam that’s highly efficacious and extremely well tolerated, even in these sensitive areas.

 What’s funny, because you’re talking about the azoles, patients just get into the mode of thinking, well, this is a fungal infection, this is ringworm, and you have to eventually try to break that cycle. It’s like, look, all these azoles shampoos and over-the-counter antifungals, let’s get rid of this, because it doesn’t have the mechanism that’s directed at the pathogenesis of the disease.

 And what’s interesting here is when we talk about the areas of involvement, as you mentioned earlier, and look at the patients who are in the clinical trials, the majority of patients had multiple areas of involvement. So [it’s about] simplifying the treatment regimen. We all have those patients who come into our office, they’ve seen a number of our colleagues, and they have the bag. I mean, do you all see the bag?

 The suitcase. The bag usually has some demon eggs in it too.

 And you know what happens is that we make treatments so complicated. I say we give patients so many things to do, and in this case, if it’s the scalp, it’s the face, it’s the body, and then they go home, and you give them several things, I say they end up incapacitated by fear, because you gave me so many things to do, I just don’t even know what to do, but say I have a little clobetasol, I know that that worked OK, my scalp was a little bit better, so maybe my face is a little bit better…. I had a patient this week who came in with very significant rosacea, and [the treatment] came from somebody, he’s like, “Well, I have something on it, I don’t know what it begins with, maybe it’s a B or something like that.” Turns out this patient was using a very potent steroid that he had gotten for somewhere else, but he started to notice that if he used it on his face, things went away faster. But then it becomes this vicious cycle, and you can get a steroid-induced rosacea. So I think the idea of simplifying and giving patients one thing to do once a day really helps with this whole process.

 That goes back to what we were talking about before with what else is concomitant, right? The acne patient who’s still got seborrheic dermatitis up here, but a lot of forehead involvement with comedones; the rosacea patient who’s got seborrheic dermatitis; even the tinea versicolor patient; we’ve seen overlap with those. So you’re right about trying to be a minimalist, but at the same time, we have to spell it out for them on what each step means to the process. We’re talking about the disease they’re not going to cure, right? This is something that they’re going to be treating, but maybe they can at least wind down to the number of things they’re using.

 Absolutely. So any other thoughts on the clinical trial? Anything that struck you in terms of the design? How important is it? And I want to know, we have lots of different treatments, and we have potentially once-a-day treatments versus twice a day treatments. Does that really matter? Shawn, I’m going to start with you. Do you care if something’s a once a day or a twice a day, or do you feel like you’re setting your patients up for better success if it’s a once a day?

 The once a day gives me a lot of ease, because I think it’s much easier to follow for patients. When we were talking about the different therapeutics, I was thinking about how we break particular topical steroids, for example, and then from our perspective, the provider perspective, we write, “Do not apply longer than 7 days to this area” in all caps, then we get a little bit worried. And how simple is it to just have a once daily preparation for patients? So I think that’s great for patients, it’s great for us too.

 Yeah, and Adelaide, we go back to the mechanism of action, and we have the other topical PDE4, but there’s a difference here, right? That one [is] twice a day versus once a day, ointment versus a foam, which is also available on a cream. What about for a kid? Does it matter once a day versus twice a day?

 I think it’s huge. I think every parent is very grateful if we have a product that they can just use once a day. Now many 9-year-olds are mature enough to take over some of their own skin care. It varies with the child in the household, but I think anything that simplifies the regimen is a value added. I also think that, we haven’t mentioned it, going to the pharmacy and having just 1 co-pay instead of the 3 co-pays for 3 products, which patients could confuse, is another value added. That wasn’t part of the study, but that’s the reality that our patients face when they have to buy medicines in multiples, and we want to simplify that part of their life as well.

Transcript was AI-generated and edited for clarity. 

Videos

Experts explore the challenges of multi-product topical treatment algorithms for seborrheic dermatitis (SD) and the value of once-a-day solutions in fostering adherence, improved quality of life, and overall better outcomes.

Dermatologists discuss the safety and efficacy of roflumilast for seborrheic dermatitis (SD).

The Safety and Efficacy of Novel SD Treatment

 We have a lot of really interesting data, and maybe you can help us…understand what about the safety and tolerability?

 We actually, from the phase 2 study, have 24- to 52-week open-labeled data for roflumilast. It was well tolerated with low rates of adverse events. Actually, there were no imbalances between the treatment arm and the placebo arm and most of these adverse events were mild or moderate in severity. Most patients with hypo- or hyperpigmentation experienced a full resolution as well.

 OK, so do I have to worry about this? The scalp has really tremendous penetration, right? We all know if we do a scalp biopsy, for me, I usually hit a blood vessel almost every time. We’re going to be bleeding, and we know penetration is great. Do we have to worry about systemic absorption? Is that something that would concern you or not really?

 Not from the trial data because we know this is also going to be very localized areas and we didn’t see any signals there in terms of any adverse outcomes.

 And we know that [oral] PDE4 is used in dermatology and it’s safe, and so I agree. It’s not something that would concern me. When we think about a nonsteroidal, the first thing that comes to mind for me is, and this is true for psoriasis or atopic dermatitis, when we think about nonsteroidal, the first thing I think about is maybe very modest efficacy, but I also think about stinging and burning.

 Yeah, and that was the knock, unfortunately, on the few predecessors that came to market. Some of that was probably more vehicle-driven. Some of it was activity on the active rash that was perceived, because you put some of those same medications on normal skin and there was no stinging and burning. So, a lot of it you could also blame on the rash itself. It’s contributing to that. But from what we saw in the studies, the foam didn’t contribute to any of that, which is good. Again, seborrheic dermatitis doesn’t have as many open areas. It’s probably not as fissured. It’s not as volatile for some as atopic dermatitis would be on the different parts of the skin. That being said, though, a nice, elegant foam is going to lead to long-term adherence, which I think is just as pivotal to the long term about using nonsteroidal drugs because I want to be able to give someone 6 months of this and say, “Let’s just go to work.” I don’t want to worry about atrophy. I don’t want to worry that they’re using too much or doubling the dose. And even more so, when we go back to where we’re treating, think about the chest or even the intertriginous areas, if there

is seborrheic dermatitis there, especially scalp and face, you really don’t want to have to be thinking about how many prescriptions do I have to limit, or are they going to go out and shop this from somebody else? The vehicles that incorporate nonsteroidals will not have the issues. But again, we can’t blame our predecessors for what we have now. Now we have to think about where we’re going forward with incorporating the right molecule in the right vehicle.

 I also wanted to add to that because I think as trialists, one of the things we notice that with the patient in short hair or long hair, they all valued this vehicle. They found it was really great. They weren’t applying the vehicle or the medicine all the way down the hair shaft, but I found that male and female patients equally found it acceptable, tolerable, and whether the patient was 9 years old or 50 or 60 years old, there was really good acceptance of this product. And many of them commented about they liked the way it actually made their hair feel. That wasn’t a captured comment, but they just spontaneously brought that up during the course of the trial.

 There wasn’t any residue. There wasn’t anything that they felt like, “Oh, I’ve got to redo my hair.” And even more, we’re still reminding them, “Treat your scalp. Let’s focus on where the disease is, which is in your scalp.” Or in the case of what we could do for it, different hair-bearing areas around the neck or the upper shoulders or the mid-chest and men, these are all areas that have all been difficult to treat with the wrong vehicle.

 Now we’ve talked about the vehicle and patients with skin of color. And I had patients who had various hairstyles, various skin types, and I agree. It was uniformly accepted, even in women who have skin of color who maybe wash their hair once a week or even every other week, and still found that this was an acceptable vehicle, an acceptable topical that they could use every day without a problem. And I want to go back to something interesting about foams, because not all foams are the same. In the past we’ve had hydroethanolic foams that when you put them on, [they have] high amounts of alcohol that sting and burn. This is not this is not the same foam; it’s different.

 Well, it goes back to the excipients. The excipients are going to cause irritation or potentially be an allergen. That’s going to be very dose limiting. But to your point about the spread, like think about someone who wears their hair in braids or cornrows, someone who has longer [hair], or, like Adelaide said, maybe some shorter hair, application of the foam into the scalp still has to be the pivotal way of delivery that everybody has to be taught. So if the right foam is going there and it has an easy spread and it’s not going to leave residue or sting, then I then will maximize adherence for the long run.

 Neal, I just wanted to add, I’m glad that you mentioned excipients, [as] we know not all vehicles are the same. The main purpose of the vehicle is to get that active ingredient…into the target [area], and depending on what excipients you’re using, it could be poorly well tolerated. We do a lot of patch testing, and we are seeing a pretty significant amount of propylene glycol allergies. I think it’s important to recognize that this does not have propylene glycol in it; it’s extremely well tolerated.

 Now, Adelaide, this was tested down to age 9. Are you comfortable using a topical PDE for inhibitor, even one that’s much more potent than the ones we’ve seen in the past, on a 9-year-old child?

 Absolutely. Based on the safety data we have from the study as well as a maximum-use study, this drug was very well tolerated; the patients really liked it. The other thing [is], I think because patients had tried things before that that weren’t that good, that’s why they kept coming back. When they finally got to a product that benefited them, that was well tolerated, they liked it on their hair, they were really exceedingly happy to finally discover that there was hope for the future, [that] we might get a medication in a good vehicle that could really help them with their seborrheic dermatitis. But I think the children tolerated [it] absolutely as well, at least in my experience, as the adult patients we enrolled.

 So, [it’s an] interesting study. Interesting in the fact that we looked at kids we looked at adults we looked at mild, moderate, or severe. We have a 0.3% foam. Shawn, going back to [what I] asked you before, now I’m coming into your office. I’ve used over-the-counter products, maybe I’ve used a prescription or 2 or 3. How would you incorporate this into [treatment for] a patient who has maybe moderate seborrheic dermatitis? Maybe I have it in my scalp, but I might also have it on the body.

 I have a lot of confidence in roflumilast foam in particular, because we have the clinical data back in and up. For these other agents that we are using, we actually don’t have much data, if any at all, in seborrheic dermatitis. So that gives me a lot of confidence, and I think the mechanism of action of the drug being able to target these different ends of inflammation, as we talked about, makes it for me a clear frontline choice. I would probably go with it first.

 Yes, it goes back to what we were talking about before, bringing drugs to market so they can get FDA-approved. There’s one thing to be FDA-approved, there’s another thing [for it] to work. If it actually works, then we can actually go back to saying, look at all the data behind it, even though there’s no phase 3 study with X amount of patients in it to bring it to a market label. So, again, that comes back to us, being able to talk to the patients and say, “This is the most effective treatment on the market based on the trials.”

 And sometimes we get a new drug in an area where there are so many drugs approved, but here we’re getting a new agent where there is nothing.

Dermatologists discuss the safety and efficacy of roflumilast for seborrheic dermatitis (SD), highlighting its tolerability across backgrounds and age groups, safety in pediatric care, and the unmet need it fulfills.

Dr Linda Stein Gold shares a clinical pearl on taking care of patents with plaque psoriasis from her practice.

A Clinical Pearl on Plaque Psoriasis

I think our psoriasis treatment landscape is in a really fantastic place. We are able to get our patients under control better than ever before. I think it's really important to make sure we educate ourselves on all the treatments that are available and make sure we understand each one of the drugs, how it's administered, what we can expect. And then on the other side, make sure we ask our patients, “How does psoriasis impact your life?” Don't be afraid to be aggressive even at the start and reach for systemic therapies even if patients have more localized disease, especially if the disease is in special areas. Patients often don't even remember what life was like without their psoriasis. So set them up with an agent that they can be successful with. Make sure it meets their needs and their desires. Always ask about joint pain and swelling. And remember that psoriatic arthritis is more common in those patients with nail and scalp psoriasis. So bottom line, really get a full understanding of how psoriasis impacts our patients and make sure that you're aggressive in trying to get that patient under control.

Transcript is AI-generated and edited for clarity and readability.

Expert dermatologist shares recent data on systemic therapy for patients with moderate psoriasis.  

Recent Data on Moderate Psoriasis

 Traditionally in clinical trials for systemic medications, we lump patients together as moderate to severe disease and we define them as at least 10% body surface area and their investigator's global assessment or the quality of those plaques is either moderate or severe. Now, traditionally patients who have moderate to severe disease, but on the lower ends, those patients with maybe 10 to 15% body surface area are in a unique situation because these patients really are appropriate potentially for topical therapy, which is often studied in up to 20% body surface area for oral medications or for biologic agents. So they have that sweet spot of saying, “Well, I can treat these with any modality that is appropriate.” But often what we do is in this particular population who has the lower end of the moderate to severe disease, we often wait on potent biologic agents and favor other treatment modalities. But is this the correct decision? Is that the best thing for our patients? So we had a recent study that looks specifically at this population, that population that has the overlap of options for their treatments. And these were patients who had more moderate disease and IGA of moderates. They had a body surface area of 10% to 15%. And this was a trial looking at risankizumab as compared [with] apremilast in adult patients with moderate plaque psoriasis who were candidates for systemic therapy. And the reason they picked apremilast is, this is often a go-to agent for those patients, often as a first step to systemic therapy. And again, the question is, “Should we be going step-wise for these patients with more localized disease, even though it's up to 15% or should we go for a heavy hitter straight out of the gate?” What was interesting about this study and what surprised me the most is when we look at the mean body surface area. Remember, it was 10% to 15%. The mean body surface area in this study was 13%. When we looked at risankizumab in the primary phase 3 clinical trials, the mean body surface area was double that. So it's pretty much half at this point yet. When we look at the DLQI, or the Dermatology Life Quality Index, the DLQI for the moderate patients was almost unchanged. As compared with those moderate to severe patients. So we cut the body surface area in half, yet the DLQI barely budges. In the original studies where the DLQI was 13.2 and in this moderate study, it's only 12.6. So less than one point, even though we have half the body surface area. And if you think about it, that makes sense. These patients are suffering. You can have a big plaque on your elbow that might be 6 inches.

And if that plaque is only 3 inches now, does it really make a difference to your quality of life? You still can't wear a short sleeve shirt. So the effect on quality of life is significant even though they might have more localized disease. So what treatment do they really deserve? And when we look at the primary or the co-primary end points at week 16, the easy 90 for risankizumab was 56. And for apremilast, it was 5. And when we look at those patients who got the clear or almost clear at week 16, it was 75%. with risankizumab vs 18% with apremilast. And finally, how many patients got to a DLQI score of 0 or 1, meaning this rise has no longer had an impact on their overall quality of life. 54% with risankizumab vs 14% with apremilast. So both of these drugs are safe and the safety profiles were consistent with the known safety profiles for these particular drugs. So the bottom line from this study is don't underestimate the impact that psoriasis has even on those patients with 10% to 15% body surface area. We have a lot of good options and let's make sure the patients get the treatment that they need. 

Linda Stein Gold, MD

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