There are currently no FDA-approved prescription treatments for common warts, instead dermatologists must rely on painful alternatives like cutting, burning, and freezing.
The phase 2 WART-203 trial evaluated the efficacy and safety of a 45% hydrogen peroxide solution (HP45) for the treatment of warts. The topical solution was compared to a vehicle in 159 patients with common warts (verruca vulgaris).
Neal Walker, MD, president and CEO of Aclaris Therapeutics, spoke with MD Magazine® about the study at the 2019 Annual Meeting of the American Academy of Dermatology (AAD) in Washington, DC.
Participants received treatments on a target wart twice per week over the course of 8 weeks, once per week at the study center and once per week by the patient or a guardian. By week 8, the proportion of treated patients with their target wart clear was statistically significantly greater among patients treated with HP45 (25.3%) compared to those treated with vehicle (2.6%; P <.0001).
By the final study visit at week 20, the proportion of patients with the target wart clear was significantly greater in the active treatment group (37.3%) versus the vehicle group (11.8%; P = .0002).
The posters, “Efficacy and Safety of Hydrogen Peroxide Topical Solution, 45% (w/w) for Treatment of Common Warts: 8-Week Results From the Phase 2 WART-203 Trial,” and “Long-Term Efficacy and Safety of Hydrogen Peroxide Topical Solution, 45% (w/w) in Patients With Common Warts: Posttreatment Results From the Phase 2 WART 203 Trial,” were presented at the AAD Annual Meeting held March 1-5, 2019.
What was the WART 203 study investigating?
Sure, so one of the things that we're really passionate about at Aclaris is going after areas where there are no FDA-approved treatments. So, we started looking at common warts because it's one of the biggest unmet needs for patients. It's a big pain point, both for the patient and the physician when you don't have an effective treatment. So, we started looking at this, we started studying this a couple years ago, doing a couple of early phase 2 studies and just trying to define what the dose range was for A-101 in the treatment of common warts. And then, what we are presenting here at the [AAD] meeting is data from the last phase 2b study, where we looked at 159 patients and we dosed the product just twice a week over 8 weeks, which is a really compelling target product profile. Because if you can get rid of a wart in that amount of time that compares very favorably to other treatments that exist right now. People have to go over the counter or use things off-label and use it for months on end with very little resolution. So, how we're thinking about it is a very quick treatment for docs to provide to their patients that they can use at home.
What is the current treatment paradigm for common warts?
When patients come in, they're usually offered some sort of destructive treatment in the dermatology office, whether it's freezing, cutting, burning, something to destroy the wart. And you can imagine, if you have a child—and we saw this when I used to practice—you usually get one bite of the apple with that process. Because it really hurts a lot, it's an unpleasant procedure, and certainly that is helpful and it works, but you often have to come back many, many times. That actually frustrates the parents as well.