A common acne medication may do more than clear skin.
In a late-stage clinical trial, a higher concentration of it helped men with androgenetic alopecia (AGA) regrow and retain hair, with effects lasting over a year.
“This is highly encouraging news for the millions of men affected by pattern hair loss, a chronic condition that requires a long-term, continued treatment,” Dr. Joshua Zeichner, director of cosmetics and clinical research in dermatology at Mount Sinai, who was not involved in the study, told The Post.
The topical drug had a strong safety profile over 12 months in a late-stage trial. Syda Productions – stock.adobe.comThe year-long extension builds on December data showing the medication, called clascoterone 5%, spurred significant hair growth in 1,465 men over six months.
“As a topical anti-androgen, it works directly on the hair follicle to target the underlying cause of male pattern hair loss,” Zeichner explained.
When applied to the scalp, clascoterone blocks the hormone DHT from binding to receptors at the hair root, helping prevent follicles from shrinking and becoming less capable of supporting healthy hair growth.
Like other hair growth drugs, though, you need to stay on it to maintain results. Over a full year, men who stayed on clascoterone saw a 2.39x improvement in hair count — while those who stopped experienced a “measurable and meaningful decline” in crown coverage.
Clascoterone continued to be safe for participants, with a profile comparable to placebo.
That’s at least partly because it’s designed to break down quickly and act only on the skin, rather than circulating in the bloodstream — limiting systemic absorption and reducing hormone-related side effects.
If approved, the findings suggest clascoterone could be a well-tolerated option for the long-term treatment of male pattern hair loss.
Such a medication, Zeichner said, would fill an “unmet need” for patients.
Patients who discontinued the treatment quickly saw their hair regrowth wane. Chris – stock.adobe.com“Unlike minoxidil, which doesn’t address hormonal drivers, or finasteride which can have systemic side effects, clascoterone offers a more targeted, locally acting approach,” he explained.
The clascoterone 5% topical solution uses the same active ingredient found in Winlevi, Cosmo’s FDA-approved treatment for moderate to severe acne in patients 12 and older. Since launching in the US in 2021, the medication has been prescribed more than 1.8 million times.
Androgenetic alopecia — commonly known as male pattern baldness — accounts for over 95% of hair loss in men.
By age 35, two-thirds of American men experience some degree of visible thinning, a figure that climbs to about 85% by age 50, according to the American Hair Loss Association.
While some embrace baldness, for others, the experience can be distressing. Studies show many men with androgenetic alopecia report anxiety, helplessness and reduced self-esteem.
“It affects confidence, identity, emotional wellbeing and quality of life for millions of men every day. Yet physicians have had very few truly new tools to offer patients for decades,” Dr. Michael H. Gold, founder of the Gold Skin Care Center, said in a press release.
“Clascoterone has the potential to redefine the treatment landscape in male AGA … and become the long-awaited new standard of care for patients seeking meaningful regrowth with strong tolerability,” he continued.
Looking ahead, Cosmo is moving forward with plans to file a New Drug Application in the US for clascoterone 5% topical solution, with a submission to the FDA expected early next year.
“I’m very excited that a new and effective option may become available soon for my patients,” Zeichner said.
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