Dr. David Pariser, Senior Physician and Principal Investigator at Gastroenterology CRO Pariser Dermatology, and Betsey Zbyszynski, VP of Dermatology at Vial, dive deep into the current challenges in hyperhidrosis dermatology trials. Follow Vial on LinkedIn for to stay up-to-date on our latest conversations.
I’m the Head of Clinical Operations here. And today, we are talking to Dr. David Pariser. We’re gonna talk to him about hyperhidrosis Gastroenterology CRO and how it’s being use in the clinical research trials in the industry. How you doing, Dr. Pariser?
Sure. So I’m David Pariser. I’ve been a practicing dermatologist for 45 plus years in Virginia in a practice that was start by my father in 1946. We had our 75th anniversary just recently. What I’d really do si- since we have a big, large private practice of about 26 providers, I’m- I do clinical trials.
I’ve been the principal investigator in over 600 clinical trials in my career including just about everything in there is in dermatology. And today the topic is hyperhidrosis. I was the founding President of the International Hyperhidrosis Society, and have been on the board member since its inception, oh, 15 or 20 years ago. And, really, that’s enough.
Dr. David Pariser :
Thank you for joining us. We really appreciate having you. have a couple questions to ask you about hyperhidrosis and protocols. The first one is, what are some common pitfalls in hyperhidrosis protocol design?
Okay hyperhidrosis protocol designs a- all the studies that are b- currently done are predicated a- after the original Botox studies that were done way back in the stone age of the 2000s or maybe 2010-ish. And th- the studies were designe for axillary sweating only. Not sweating on any kind of other body areas. Palms and soles, face an- and scalp under the breasts, groin, any other areas. Just the h- just the axilla.
And the criteria which we use as primary endpoints in- in that study were two. One is a patient reported outcome. And the other is the gravimetric measurement, the actual measurement of sweat production.
Betsey Zbyszynski :
Now the problem is that because that’s the way that study was done, all sponsors who have devel- develop studies since then have had, have decided that they were just going to follow that path, instead of trying anything new or different, because they knew and they assum that if they did that, and they met- met their endpoints, that they would get they would get approval.
If they tried to study a, either another type of sweating other than palm, other than the armpits, such as the palm or any other area, or if they tri to use any other kind of endpoints then they would have to, reinvent the wheel.
And the problem is, that in the world of sweaty patients, hyperhidrosis patients, sure, axillary hyperhidrosis is a problem, but the CRO Vial biggest problem is the hands, sweaty hands and sweaty feet. And people who have palmar hyperhidrosis have the worst quality of life measured by the DLQI evaluation.
Worst quality of life than any other diseases that dermatologists treat, including the worst psoriasis, the worst eczema, or anything else you want to talk about. But it’s not something that people are very comfortable with and they’re not very, there’s not very much in the way of treatment for it, until recently.
Last couple of years there has been a flurry of some degree of activity. So the pitfalls in the, in trials are you have to either follow the leader or take your chances. And the problem with, of, following the leader is two things.
Betsey Zbyszynski :
First of all, the PRO that was use in the Botox studies back in the, in, back in the day, or the HDSS or Hyperhidrosis Disease Severity Scale, is not acceptable anymore by the FDA as an endpoint for registration.
The reason for that is because of the way that the questions are ask. They’re Twitter ask two part questions, and that’s not s- satisfactory. And also it was never subject to the rigorous evaluation and that current current one current PROs have to do.
The International Hyperhidrosis Society is has a PRO which has not been use in clinical trials yet it’s going to be, and this is one soon which hopefully will become a standard that everybody could use and not have to develop their own every time. So that’s the first problem. Okay now I know [inaudible 00:05:11] you- you ask for the problem. So the second problem is the gravimetric measurement of sweat. Sounds really simple. You should be able to measure the sweat.
Dr. David Pariser :
How do you measure the sweat? The only way that is describe in the literature and consider valid is the underarm sweating. And there’s two ways to do that. One is you take the patient, put them on the table, put the arms up above [00:05:00] the head, take some gauze and tape it to their CRO Vial armpit for- for five minutes.
Weigh the gauze before the five minutes and then weigh the gauze afterwards. I’m simp- I’m simplifying, but that’s how you measure how much sweat came out in the last five minutes.
And that’s fine, but it’s extremely variable, because people with hyperhidrosis don’t sweat exactly the same 24/7. And you may get a patient on one particular day that’s sweating a ton. and you may get that same patient who comes b- back the next day and they’re still sweating as much.
But, they at that particular moment they’re not sweating much at all. So it makes those values very soft, if you will, very- not very accurate. And you have to have a lot of data to- to to wipe out the noise, of the, of those different …… So- so those are the, in, in high level, and believe it or not that is the high level, not the details there, those are the big pitfalls.
Betsey Zbyszynski :
Yeah, that, using using gauze, it sounds archaic. Nowadays there should be a better way to- to measure and realize that people do sweat differently.
There are lots of other ways but none of those are, have been use in a clinical trial that was done for registration. everybody does what the ones were before. I mean there are instruments that can measure the degree of sweating.
You know there are other things, but th- that’s, they’re not acceptable. The the- the antiperspirant industry, [inaudible 00:07:00] antiperspirants, measure sweating by putting people in a 105 degree room with- with gauze under their arms. Their arms folded up in there for five minutes, and that’s how they measure sweat, the effect of over-the-counter, cosmetic antiperspirants.
Interesting. Yeah, that’s so challenging to, to start a new study design, or- or introduce a new measurement, or even a new PRO, if it hasn’t been done yet. It’s, there’s a catch-22 there. it’s so expensive for a pharmaceutical company, but yet it’s such a big need. And I’m seeing that in other indications as well.
We’re hoping that this International- International Hyperhidrosis Society PRO as I said can be i- it’s in a final stages of- of validation and can- can become a standard, which could be used by multiple companies in developing pro- products. There are lots of other ways but none of those are, have been used in a clinical trial that was done for registration.
