New baldness treatment shows dramatic gains in hair growth in major trial
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A new experimental scalp treatment called clascoterone has shown strong results in helping to reduce male pattern hair loss (also known as androgenetic alopecia or AGA).
Experts call the results promising and say this could be the first new approach to reversing hair loss in decades.
Conducted by Cosmo Pharmaceuticals in Ireland, the two large late-stage trials, called Scalp 1 and Scalp 2, enrolled a combined total of 1,465 men in the U.S. and Europe, according to a news release.
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Participants used the topical solution or a placebo under randomized conditions. The main measure of success was the “target area hair count” (TAHC), a target count of hairs in a defined area of the scalp.
The topical solution works by blocking the action of dihydrotestosterone (DHT), a hormone that causes genetically sensitive hair follicles to shrink, directly at the follicle receptor instead of affecting hormones throughout the system, according to Cosmo Pharmaceuticals.
Cosmo Pharmaceuticals reported strong phase 3 results for clascoterone in the treatment of male pattern hair loss. (iStock)
This localized approach attempts to address the biological cause of AGA without exposing the body to additional hormones.
In the Scalp 1 group, clascoterone showed a 539% relative improvement in hair count compared to the placebo group. Participants in Scalp 2 showed a relative improvement of 168%, according to the release.
“We don’t really have a very effective cream or lotion for hair loss, so it may be valuable for widespread clinical use.”
One study showed “statistical significance” in patient-reported outcomes, while the other showed a “favorable trend,” the release noted. When data from both trials were combined, the improvement was described as “statistically significant” and aligned with the hair counting results.
“For decades, patients have had to choose between available treatment options with limited efficacy or safety concerns due to systemic hormonal exposure, often resulting in patients not treating their hair loss at all,” Maria Hordinsky, MD, of the Department of Dermatology at the University of Minnesota, said in a statement to News Digital.
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“These findings show the potential for clascoterone topical 5% solution to change that equation by generating real, measurable regrowth with negligible systemic exposure,” Hordinsky added.
Patient-reported outcomes (how study participants perceived their hair growth) were also positive.
If approved, the treatment would be the first new approach in nearly three decades. (iStock)
“I think this is promising,” Marc Siegel, MD, News senior medical analyst, told News Digital. “We don’t really have a very effective cream or lotion for hair loss,” added the doctor, who was not involved in the study.
Minoxidil lotion, one of the most widely used and FDA-approved topical treatments, generally has limited effectiveness, Siegel noted. “Therefore, this may well be valuable for widespread clinical use.”
Limitations and potential risks
Siegel, who was not involved in the trials, referenced the study’s claim that the only side effect was “local irritation” and said the drug appeared to be generally safe.
The safety and tolerance of the drug appeared to be comparable to those of the placebo group. Side effects were minimal and occurred at similar rates in both the active and placebo groups, and most were found to be unrelated to the medication, according to the researchers.
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The researchers noted that the improvement in the study participants was compared to the placebo group in the study; does not guarantee that men will grow five times more hair than with other treatments.
The safety results of the drug were similar to those of the placebo, with no unexpected adverse effects, the researchers said. (iStock)
Each individual’s results depend on the amount of hair they had to begin with, and without complete data, it is unclear how much visible growth most men will achieve.
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“You need to be careful with allergic reactions and, in rare cases, adrenal insufficiency, since the cream is an antiandrogen,” Siegel cautioned. This means that because this treatment blocks androgens (male hormones), it may slightly affect the adrenal glands, which help the body control stress hormones.
Full data, including long-term outcomes and detailed changes in absolute hair count, are still pending regulatory review. (iStock)
Furthermore, these are top-line results, as more detailed data, including long-term durability, variation between different degrees of hair loss, and extended safety over 12 months, have not yet been published.
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If approved, this would be the first scalp treatment that works by blocking DHT directly in the hair follicle, the first of its kind made specifically for hair loss in men, the company says.
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Cosmo plans to complete a full 12-month safety follow-up by spring 2026 before submitting the drug for regulatory approval in the US and Europe.
Khloe Quill is a lifestyle production assistant at News Digital. She and the lifestyle team cover a range of topics including food and drink, travel and health.