Narrator:
0:01
Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased evidence, proven facts powered by ENCORE Research Group and hosted by cardiologist and top medical researcher, Dr. Michael Koren.
Dr. Michael Koren:
0:17
Hello, I'm Dr. Michael Koren and this is Dr. Michael Bernhardt, and we're here for another session of Two Docs Talk, but in this case we're in our second section. We established in our previous section that you are now fully poddy trained. I'm poddy trained. Our last talk was his first podcast and this is now Michael's second podcast and he's I am much relieved. He's used the facilities and now we're here to talk about acne. But from the perspective of some of the clinical research work that we're about to embark on, and just for those of you out in the audience, Michael and I have worked together for a long time. Michael is a tremendous dermatologist. We've worked together in clinical trials for a number of years and Michael is leading a project here in Jacksonville which we are particularly excited about, which is using messenger RNA vaccine type technology to treat acne. So why don't you help our audience understand first why this is necessary we talked a little bit about that on the last session, but to catch everybody up and then why you're excited about this particular trial.
Dr. Michael Bernhardt:
1:24
I think it's really cool. And the reason I think it's cool is that right now the state of the art in acne is topical medications. Oral antibiotics escalate to Spironolactone, escalate to Isotretinoin. All good drugs. But you know Bernhardt's first law of drugs any drug can do anything to anyone at any time. Everybody's an independent variable.
Dr. Michael Bernhardt:
1:46
And I always tell patients that drugs are double edged shorts. They can help you, they can kill you. So we know there's side effects to all these things. There's morbidity, there's downtime. Mom has to take her little cherub to the dermatology office. It means she's got to leave work, he's got to leave football practice, they've got to come back. So there's a cost to it and in time there's an opportunity cost to the family and there's a pharmacy cost and there's morbidity to it.
Dr. Michael Bernhardt:
2:14
Acne can be very psychologically damaging, a study that was done at a Denmark about 10 years ago actually surprised me because it showed it was more psychologically damaging to teenage boys than to girls. Now I would have thought the opposite. So acne can be very psychologically damaging. It can lead to things like depression, suicidal ideation. So it's not a benign or strictly cosmetic issue.
Dr. Michael Bernhardt:
2:40
Poorly controlled acne that can lead to scarring and have severe consequences to the patient. My concern is I still think we're in the world of the 1980s and the 1990s in terms of our biotechnology for treating acne. I would love to see us being able to do better. So the concept of having an mRNA vaccine that's targeting specific particles of the Propionibacterium acne's bacteria, which is what we think is the pro-inflammatory trigger for people with acne, is really exciting. And in this study, what we're doing is we're looking at the usual people people over the age of 18, people that have significant comorbidities or conflicting comorbidities that would disallow from the study. Specifically, people that are past-accutane patients would probably not qualify and we're looking for people that have lesions that are approximately 20 to 25 inflammatory plus 20 to 25 non-inflammatory lesions.
Dr. Michael Koren:
3:43
We're not looking for the moderate acne, severe acne or somewhere in between.
Dr. Michael Bernhardt:
3:48
Yeah, it's cut, moderate and severe. I mean someone who has five or 10 cominones is not, you know, severe enough to merit this.
Dr. Michael Koren:
3:56
Just like in the real world In a typical clinical trial, somebody will actually count them to make sure people qualify, I would imagine.
Dr. Michael Bernhardt:
4:02
We do. We'll be counting specifically and there's a standardization of the criteria across the whole study. So it's not going to be an arbitrary judgment and we're looking for people that really need the help, just like in the real world. If someone came in with three or four pimples, I'm not going to be thinking about a vaccine, just like if someone has one palm unit of psoriasis in the elbow, I'm not going to roll out one of the biologics, right?
Dr. Michael Koren:
4:26
So if somebody comes to you and says my prom night is in five days, can you help me with this study, the answer would probably no. No, then it would be a chemical peel, right, or a light chemical peel.
Dr. Michael Bernhardt:
4:38
So the thinking with this is that we will inject people at day eight, re-inject them at day 56, following them out for about seven, eight months, and we're looking to see at least what they call an IgA two level reduction in terms of combinatorial or legional count, and that will be our primary endpoint.
Dr. Michael Koren:
4:57
Cool, cool. So this is early phase research. So when we do research, we typically do it in what we call phases, phase one being first in humans, phase two being a period of time when we're trying to find the right dosage of whatever therapy that we're using, and then phase three being the broadest phase where we really get to the efficacy and safety of the product.
Dr. Michael Bernhardt:
5:21
This is a phase one, phase two combo, so it's really phase, yeah, and so that's exciting.
Dr. Michael Koren:
5:26
It gives people access to something that is pretty new, and this is using messenger RNA type technologies. I understand it Correct. So there's lots of people that have had that at this point, we know, with all the vaccine work that's been done, you know both in the room Included, yeah, so we know that messenger RNA is different than DNA products.
Dr. Michael Koren:
5:45
I know people get that confused. Messenger RNA is really the messenger. It doesn't affect your genes. This is just the message between your genes and the parts of your body that make things happen, and we can now do things to allow our body to protect ourselves by sending the right message.
Dr. Michael Bernhardt:
6:03
Is that a fair way of describing it? Correct, and that's? I'm glad you brought that out, because that's a big misperception out there.
Dr. Michael Koren:
6:08
Yeah, yeah. So we're excited to be part of that and applying it to dermatology is that new or is that something you've seen with other products?
Dr. Michael Bernhardt:
6:15
I think this is the first thing that I've seen in my experience that we're approaching from a gene-based. Now there is a phase three melanoma vaccine in trials, but that's a different. Yeah, cancer, different ballpark, you know. But as far as general dermatology, yeah, this is the first vaccine-based treatment I've seen.
Dr. Michael Koren:
6:32
Okay, and so you started to talk a little bit about the advantages of this type of concept versus the quote 1980s 1990s version of treatment of acne. So am I oversimplifying things by saying this can be a shot that keeps you free and clear for six months eventually, or a year? so what do you think?
Dr. Michael Bernhardt:
6:52
Yeah, we're looking to see what the long term is going to be. Yeah, but I mean, my thinking is, if two injections get you basically acne-free, what's the downside?
Dr. Michael Koren:
7:01
And how would that compare with antibiotics, for example? Or?
Dr. Michael Bernhardt:
7:06
Antibiotics you use it or lose it. Now you have to use it consistently and nine times out of 10. The minute you stop, within a week or two, you're back to square one. So that's why it's all patients this is a use or lose at treadmill.
Dr. Michael Koren:
7:17
Right, n ow we do a lot of work in clinical trials here and obviously I've been very involved with it from a cardiovascular standpoint. Do you think there'll be any challenges getting people who have skin conditions to get involved in clinical trial? What's your experience and perception?
Dr. Michael Bernhardt:
7:34
Our experience has been. Since we're targeting 18 and above, I think it's going to be a lot easier to get people in. I think that adolescence is tough because it's a family strain. The kids can't drive themselves, they've got school, they've got sports, parents have to take off from work. But since we're targeting an older cohort, I don't think it'll be an issue.
Dr. Michael Koren:
7:54
Now you've been a PI in other acne studies quite a bit more of. Tell us a little bit how the patients have perceived that. Do they enjoy the experience? Do they get things out of it that may not be apparent to the average listener?
Dr. Michael Bernhardt:
8:09
I think they do. I think they do. It's helpful to be in a clinical format because it's a structured format. There's accountability. If you're not using the drug, we know it. If you're non-compliant, we know it. There's been studies. Steve Feldman out of Wake Forest did a great study about 10 years ago. We put a censorship in a bottle of tetracycline and found that 34% of people who would look them straight in the eye and say I did everything, you did never even open the bottle.
Narrator:
8:36
We know that compliance is a challenge particularly in the teenage population.
Dr. Michael Bernhardt:
8:41
Not out of malevolence on the part of the patient. Just they're busy.
Dr. Michael Koren:
8:44
They get a lot of other things going on, again.
Dr. Michael Bernhardt:
8:47
Two shots from the vaccine will be easier, I think, than having someone go through the three or four step ritual that we routinely prescribe for acne.
Dr. Michael Koren:
8:57
So there are huge compliance advantages potentially for something that uses this type of technology.
Dr. Michael Bernhardt:
9:02
Absolutely. Two injections and you're done.
Dr. Michael Koren:
9:04
How about downsides? We always like to be balanced in these discussions. Can you think of any downside of this type of technology?
Dr. Michael Bernhardt:
9:11
Risk of reaction to the injection, injection site reactions, allergic reaction to the injection, and that would be immediate.
Dr. Michael Koren:
9:17
So it's unlikely, sure, it's unlikely that this would happen and we have an extra fair amount of experience from this, from our COVID vaccines that use messenger RNA technology. It happens very, very infrequently, but not impossible, that there's immediate reaction, but can you think of any?
Dr. Michael Bernhardt:
9:33
They're looking at the pericardititis / myparacarditis in terms of whether that's going to be an issue with this vaccine. We don't expect it to be based on the technology and the fact that we're not using an agent that has a spike protein, but they're looking at that and that's an area of special interest to the group that's researching this.
Dr. Michael Koren:
9:54
Are there other technologies out there that you are aware of that are trying to treat patients with acne using newer concepts?
Dr. Michael Bernhardt:
10:02
We're using red light therapy where you paint Melphalan, which is a variant of one of the topical PDT acids. You paint Melphalan on you, let it sit for about 15, 20 minutes, put the patient under red wavelength of light for 10 minutes per side. There was just an article that was published last month in the Journal of the American Academy of Dermatology out of China, where they did that weekly and got a six-month clearance level that was similar to someone who'd been on Isotretinoin. So we've started doing that in our clinic over in Tallahassee with patients also.
Dr. Michael Koren:
10:34
Interesting, Interesting. Let's also just make sure that we're covering everything. Some of the questions we get, especially when we talk about this high-tech stuff. They say, well, aren't there simple things? I got an interesting question in my last presentation to a live audience at the local TV studio. They said well, can a supplement do all this? Why do we need all this expensive high-tech stuff? Let's answer that fairly. Can we just change your diet and the acne will go away? Is there a supplement that make it go away? If that, worked.
Dr. Michael Bernhardt:
11:07
I wouldn't be seeing patients with it because everybody tries that before they go, by the time they get to me, I'm ahead of a residency clinic. By the time they get to me, they've seen the minute clinic, they've seen their primary care doctor, they've seen one of the other dermatologists in town, and then they're coming to us because they're end stage. So if any of this simple treatment worked, they wouldn't be coming to me. So I guess the answer is in our population none. Now maybe there's a cohort out there that have done the simple things. They're better. I don't see them. That's great. And the population that we treat? The answer is no.
Dr. Michael Koren:
11:43
So I will leave it this final concept. So I loved the fact that you talked about that. We're still kind of stuck in the 80s when it comes to acne treatment, and we talked about this a little bit before we got on the podcast that we're both musicians that happen to love music from the 80s. So there's some good things from there that we'll keep on going back to and there's other things that need to evolve and get into a more modern phase, and it doesn't mean that you throw away the old stuff, but there's certainly room for some of the new stuff.
Dr. Michael Koren:
12:16
Absolutely right, yeah. So with that in mind, Michael, thank you so much for being part of this. I learned a lot. Hopefully our audience learned something during the discussion. I'm sure they did, and you're always welcome back, and if there's anything we can do to support your very, very interesting research, please let us know. Thank, you.
Narrator:
12:33
It's a pleasure. Thanks for joining the MedEvidence podcast. To learn more, head over to MedEvidence. com or subscribe to our podcast on your channel, your favorite podcast platform.
