Everything You Need to Know
About Winlevi, the Newest Acne Rx
Even though acne is one of the most prevalent skin diseases out there—affecting up to 50 million Americans annually—treatment options have typically revolved around the same few key ingredients.  Truly new innovations are somewhat of a unicorn in the acne space, making the recent launch of Winlevi, a topical acne cream shown to reduce the amount of pore-clogging sebum produced by your skin, even more exciting. Ahead, Linda Stein Gold, M.D., a dermatologist in West Bloomfield, Michigan and Chair of the Acne Store board of dermatologists, explains everything there is to know about this brand-new acne-fighting option.
Q: What is Winlevi?
A: Winlevi is the brand name for a drug called clascoterone. It’s a topical prescription medication that’s been FDA-approved for the treatment of acne in patients ages 12 and up. 
Q: How does Winlevi acne cream work and how does it differ from other acne treatments?
A: First, let’s talk about what causes acne. There are four key factors at play: bacteria, clogged hair follicles, inflammation, and excess sebum production. The current topical acne medications out there have been able to hit three of those four, but there haven’t been any topical acne therapies that could address the excess sebum. We could only do that with oral hormonal medications—until now. That’s what makes the Winlevi acne cream unique. It prevents androgens, hormones such as DHT, from binding to the sebaceous glands. We know that when androgens do bind to the androgen receptors on those glands, it not only causes the production of sebum, it also triggers inflammatory molecules. In short, if a drug can block the activation of the androgen receptors, it can decrease both sebum production and inflammation. So Winelvi is hitting two of those four acne-causing factors.
There haven’t been any topical acne therapies that could address the excess sebum. We could only do that with oral hormonal medications—until now.
Q: How does topical Winlevi cream compare to oral medications that have a similar mechanism of action?
A: One in vitro study compared clascoterone to spironolactone, an oral medication that is also an androgen receptor and is commonly prescribed for acne patients.  It looked to see how effective both are at decreasing lipid production in the sebocytes, and it turns out that, for the majority of samples, the clascoterone was actually more potent.
Q: Who can use Winlevi to treat acne?
A: What’s noteworthy about Winlevi is that it can be used to treat acne in both men and women. We don’t prescribe oral spironolactone for men because it can have unwanted side effects, but this is an anti-androgen medication that is okay for men to use. As mentioned, it’s FDA-approved for patients 12 years and older. In the clinical trials, it was used on patients with moderate to severe acne, but only those who had papules and pustules or comedones (blackheads and whiteheads), not nodules or cysts.
Q: Are there any side effects associated with Winlevi?
A: The topical Winlevi acne cream was used twice daily in clinical trials and was very well-tolerated. People liked it. The issue with topical acne medications is that they can dry out the skin, but when we looked at irritation factors such as scaling, dryness, and itchiness comparing the vehicle versus the drug in this case, there was no difference.  We’ll have to wait and see if the fact that it must be used twice a day poses any issues when it comes to patient compliance. We did see a reversible effect on the HPA axis, which is an endocrine pathway, which resoled within 4 weeks of discontinuing medication.
Q: How do you see Winlevi fitting into the larger arsenal of existing acne medications and treatments?
A: It just hit the market and I only used it in the clinical studies, so as it gets into the hands of more dermatologists, we’ll learn more about how the Winlevi acne cream really works. It was studied as a monotherapy, and it hasn’t been studied in combination with other drugs. But in the real world, I see it being used alongside other treatments, because it fills in that missing link with its unique mechanism of action. For example, I think pairing it with a topical retinoid would be a nice combination. It really could be a good fit for almost anyone, so long as their acne isn’t nodulocystic, and it does make sense to add it to pretty much any type of treatment regimen.
Linda Stein Gold, M.D.
Dr. Linda Stein Gold, Chair of the Acne Store Board of Dermatologists, is the Director of Dermatology Clinical Research and Division Head of Dermatology at the Henry Ford Hospital in Detroit. She received her medical degree from University of Pennsylvania School of Medicine in Philadelphia, completed an internship in the Department of Internal Medicine at the Hospital of the University of Pennsylvania in Philadelphia.
Acne Store is coming soon! Join our mailing list for updates, exclusive content,and deals and discounts.