Despite the fact that acne is the most common skin condition, affecting up to 50 million Americans annually (this according to the American Academy of Dermatology), it’s not a category where there’s a lot of innovation. Whether they’re over-the-counter or prescription, the treatments that doctors rely on tend to be the same things that have been used for decades. There are oral medications such as Accutane, spironolactone, and antibiotics, and tried-and-true topical ingredients such as retinoids, salicylic acid, and benzoyl peroxide. But the U.S. Food and Drug Administration (FDA) recently approved a new type of topical acne treatment.
Winlevi is a prescription-only acne cream that works in an entirely different manner from that of any other topicals (including the other new kid on the block, Twyneo), and it’s got dermatologists buzzing. Ahead, more on this groundbreaking medication and how it will fit into the existing arsenal of acne-fighting options.
How does Winlevi work?
Winlevi is the brand name for clascoterone, a topical medication that inhibits androgens, male hormones that impact oil production, explains Dr. Corey L. Hartman, a board-certified dermatologist in Homewood, Alabama.
So why is that exciting? “Up until now, we’ve had no topicals that address oil production, despite it being one of the main contributing factors to acne,” says New York City board-certified dermatologist Dr. Joshua Zeichner. It’s being referred to as a topical version of spironolactone, one of the most effective—and popular—oral medications used to treat hormonal acne in women.
“Spironolactone has been a very, very effective option. Even in instances when Accutane has failed, it’s helped women who have hormonal or androgen-dependent acne,” explains Dr. Sheryl D. Clark, a board-certified dermatologist in New York City. Dr. Hartman agrees, calling it a “gold standard” and noting that it’s a topic of discussion with at least 75% of his female acne patients.
While spironolactone is both inexpensive and tends to be fairly well tolerated, it isn’t without its drawbacks. Some people simply don’t want to take a pill, not to mention that men can’t take it due to the systemic hormonal effects. Similarly, it’s off limits for pregnant women, because its anti-androgenic activity can affect the development of reproductive organs in male fetuses, notes Dr. Clark.
Who is a good candidate for Winlevi?
Winlevi is FDA-approved for the treatment of acne in patients 12 years and older. Dr. Zeichner notes that it can be used to address not only hormonal but also inflammatory acne as well as blackheads and whiteheads. Perhaps most noteworthy is the fact that it is a safe option for both male and female patients, something Dr. Zeichner says is a huge benefit.
The FDA states that there’s no data to evaluate the risks associated with Winlevi use in pregnant women. But Dr. Hartman says that because there’s low systemic absorption, this is a decision he’d leave up to patients. Dr. Clark agrees: “Theoretically, there’s no reason it couldn’t be used in pregnancy, since it’s not systemically absorbed.”
How does Winlevi compare to other acne treatments?
All the dermatologists we spoke with were quick to note that Winlevi probably isn’t going to be a monotherapy; it will most likely be combined with some other type of treatment, be that oral or topical. Dr. Hartman says that if he’s prescribing Winlevi to a patient, he’s also prescribing a retinoid. Dr. Clark adds that she could see combining it with a lower dose of spironolactone (in female patients), to up the effects. It bears mentioning that Winlevi is meant to be used twice daily, which could make patient compliance challenging.
How effective is Winlevi?
“The numbers from the clinical studies showed an acne reduction hovering around 20% [after 12 weeks],” says Dr. Clark. “To me, that’s not as noteworthy as if it were 60 or 80%. However, it’s currently being compared against nightly use of a .05% tretinoin cream, and the results are trending toward Winlevi being equally effective,” she adds.
Clinical trials aside, Dr. Hartman says he has yet to get a good sense of how it performs in real life, particularly when combined with other treatments, given that it was studied as a stand-alone treatment in the clinical studies. (Even though the drug was approved in 2020, he’s been prescribing it for only about four weeks.) It is likely to work faster than oral spironolactone, however. “It takes about three to four months to see the full benefits of spironolactone, whereas the effects of Winlevi can start to show up in two to four weeks,” notes Dr. Clark.
Are there side effects?
In the clinical studies, a small number of patients experienced issues such as redness, pruritus (itching), and dryness. Dr. Clark says that she has seen these side effects be an issue and, as such, feels it will have more of a role for her male patients, whose thicker skin makes them less likely to experience irritation. Dr. Zeichner disagrees, saying that it’s well tolerated and can be used even in those with sensitive skin.
How much does it cost?
According to Dr. Clark, the price may be a big deterrent: “Without insurance, it costs $550 to $600. While the company is saying you can get it for as little as $25 with insurance, that still requires the step of getting it approved by your insurance—and that can be limiting.”
The bottom line
“Winlevi probably won’t be the treatment that cures acne forever, but it is great to have new innovative options and topical versions of oral medications. I think it will play a nice role for a subset of acne patients who previously couldn’t achieve adequate improvement,” says Dr. Hartman.
Acne aside, Dr. Clark says she’s excited about the drug’s other possibilities. “I love it as an option for people who simply have oily skin, as we really don’t have good treatment options for this problem. And in Germany, they’re currently looking at using higher doses of it, to treat androgenic alopecia, so I think other applications may come with time.”
