Opinion
Video
The Safety and Efficacy of Novel SD Treatment
Author(s):
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.
Transcript
Linda Stein Gold, MD: We have a lot of really interesting data, and maybe you can help us…understand what about the safety and tolerability?
Shawn Kwatra, MD: 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.
Linda Stein Gold, MD: 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?
Shawn Kwatra, MD: 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.
Linda Stein Gold, MD: 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.
Neal Bhatia, MD: 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.
Adelaide Hebert, MD: 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.
Neal Bhatia, MD: 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.
Linda Stein Gold, MD: 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.
Neal Bhatia, MD: 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.
James Song, MD: 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.
Linda Stein Gold, MD: 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?
Adelaide Hebert, MD: 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.
Linda Stein Gold, MD: 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.
Shawn Kwatra, MD: 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.
Neal Bhatia, MD: 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.”
Shawn Kwatra, MD: 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.
Linda Stein Gold, MD: It’s really truly an unmet need.
Transcript was AI-generated and edited for clarity.
