We caught up with Stephan Bielfeldt, our Vice President Science and Consultancy, to talk about Herpes in clinical research – and how we at proderm have all the tools at our fingertips to make these lips talk!
Interview with Stephan Bielfeldt
Hello Stephan! Today I would like to probe you a little bit about clinical trials on Herpes simplex! Considering the type of studies we conduct at proderm, what are the key skills we have at proderm, when it comes to clinical trials with herpes patients?
Yes, at proderm we are very adept at proof-of -concept studies, which are primarily about seeing whether a new product can be successful in therapy. To do this, of course, you have to find many patients with acute herpes simplex, aka a cold sore. The standard procedure is to screen a large number of people who have recurrent and frequent outbreaks of herpes simplex on their lips. When they reach the so-called prodromal stage, i.e. when they notice that their lips are tingling, then they should come to the test center very quickly and are then only included if it is actually a herpes cold sore.
Yes, and is that problematic? Herpes is relatively widespread.
Well, yes, but that’s more of a random thing – you can have the misfortune that only one in 10 comes to the study site in this defined time period and you end up starting the study with all the patients participating widely scattered and isolated over many days and weeks. If you want to test a new therapy quickly and compactly, then you don’t want to do a very long clinical study with tens of tens of weeks. You basically want to specifically trigger herpes and include the patients in a controlled manner over the span of a few days.
So by triggering Herpes in patients, we can skip the tedious process of waiting for the patients to have a cold sore attack?
Exactly! This is particularly useful for early phase studies, where the goal is to do monocentric studies with a simple design and a comparatively short timeframe! At proderm, we can set up a Herpes trial without involving 20 centers and x subjects; you can save that for phase 3!
And what do we use to trigger the cold sore?
On the basis of older American publications we use UV radiation in order to trigger the cold sore. It then usually develops within one or two days after radiation.
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