Opinion
Video
Author(s):
Dermatologists discuss the realm of emerging therapies for seborrheic dermatitis (SD), emphasizing the importance of both breakthrough and failed trials, while highlighting the need for scientific rigor and patient-reported outcomes.
Transcript
Linda Stein Gold, MD: James, maybe you can talk to us a little bit. We talked about what’s new, and it’s exciting, but is this now the front door to a whole lot of other potential therapeutic options that are being investigated for seborrheic dermatitis?
James Song, MD: Yeah, it’s always really fun when we see just how much or how little we know about a disease or the pathogenesis, and then how they respond to a certain medication, [it] does give us some insights as to what’s actually causing it, right? So, it’s translational research, I guess you could call it. I think the fact that roflumilast foam works so well for seborrheic dermatitis tells you that PDE4 is absolutely a validated target as well as [able to improve] the skin barrier. We do have another PDE4, it’s a novel PDE4 topical that’s being studied, as well as a topical JAK [Janus kinase] inhibitor; this is more of an investigator-initiated trial. But what’s also interesting is that PDT, a photodynamic therapy study that’s being done for seborrheic dermatitis, and that comes off the heels of some positive data we saw with narrowband UVB and red light. I also think it’s worth mentioning negative studies, studies that didn’t pan out. There is an antimicrobial peptide that was used because we did see higher levels of [staphylococcus] in some patients with seborrheic dermatitis, so it makes sense; let’s use an antimicrobial peptide that has antibacterial, antifungal effect. When they did a proof-of-concept study against ketoconazole and placebo, it just didn’t look all that much better than the placebo, so I think for now we can say that’s probably not the right approach.
Linda Stein Gold, MD: You bring up a really, really interesting point. We all run clinical trials, and I think that the dermatology community kind of takes it as a given, here’s a clinical trial, we run different studies, they meet their end point, we see a lovely delta of the active versus the vehicle, it’s highly statistically significant, yet as you mentioned, these trials don’t always pan out. You can have the best idea, as in this case, this last treatment, the best idea, it makes sense, it’s scientifically rigorous, it, we’re studying the right population, yet it might do well initially, and then when we bring it to those phase 3 clinical trials, it doesn’t work. And so, you have to realize this matters.
Shawn Kwatra, MD: And what it does is it helps us also understand what is driving pathogenesis. If you’re using a microbial modulating agent, and it’s not working, and then we know when you target the inflammation of these cytokines, it works, it kind of tells us what’s primary. So in seborrheic dermatitis, it’s not the microbial alterations, it’s the inflammation that’s primary.
Neal Bhatia, MD: But you know, we could try to match the mechanisms of the drug to the disease, but if it’s not in the right vehicle, or if the trial end points are flawed, or if the study population don’t meet the criteria, but all of these other variables go back to the entire design of what made the trial not pass.
Linda Stein Gold, MD: And that’s so important, because when we talk about a topical, was the drug absorbed appropriately into the vehicle, does the drug penetrate into the skin in the vehicle where it’s supplied? There are so many different factors that go into it. And then again, tolerability. One should say it’s dissolving great and it gets into the skin, but can I tolerate it? Is it causing a contact dermatitis? Is it causing a problem? Is it causing my skin to dry out? Is it causing my hair to break? These are all those little pieces of the puzzle that kind of go together.
Transcript was AI-generated and edited for clarity.