Experts call the results promising, claiming that this could be the first new approach to reversing hair loss in decades.<\/p>\n
Conducted by Cosmo Pharmaceuticals in Ireland, the two large, late-stage trials<\/a> \u2014 named Scalp 1 and Scalp 2 \u2014 enrolled a combined total of 1,465 men across the U.S. and Europe, according to a press release.<\/p>\n EXPERIMENTAL SERUM SHOWS PROMISE IN REVERSING BALDNESS WITHIN 20 DAYS<\/strong><\/a><\/p>\n Participants either used the topical solution or a placebo under randomized conditions. The main measure of success was “target-area hair count” (TAHC), an objective count of hairs in a defined scalp area.<\/p>\n The topical solution works by blocking the action of dihydrotestosterone (DHT) \u2014 a hormone that causes genetically sensitive hair follicles to shrink \u2014 directly at the follicle receptor rather than affecting hormones system-wide, according to Cosmo Pharmaceuticals.<\/p>\n Cosmo Pharmaceuticals reported strong phase 3 results for clascoterone in treating male-pattern hair loss. (iStock)<\/p>\n This localized approach attempts to address the biological root cause of AGA without exposing the body to additional hormones.<\/p>\n In the Scalp 1 group, clascoterone showed a 539% relative improvement in hair count compared with the placebo group. The participants in Scalp 2 showed a 168% relative improvement, the release stated.<\/p>\n “We really don’t have a very effective cream or lotion for hair loss, so this may be valuable for widespread clinical use.”<\/p>\n<\/blockquote>\n 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 counted-hair results.<\/p>\n “For decades, patients have had to choose between available treatment options<\/a> with limited efficacy or safety issues due to systemic hormonal exposure, often resulting in patients not treating their hair loss at all,” Maria Hordinsky, M.D., from the University of Minnesota’s Department of Dermatology, said in a statement sent to Fox News Digital.<\/p>\n HAIR-LOSS DRUG TIED TO SUICIDES, DEPRESSION AND ANXIETY IN GLOBAL STUDY<\/strong><\/a><\/p>\n “These findings show the potential for clascoterone 5% topical solution to change that equation by delivering real, measurable regrowth with negligible systemic exposure,” added Hordinsky.<\/p>\n Patient-reported outcomes \u2014 how study participants perceived their hair growth \u2014 were also positive.<\/p>\n If approved, the treatment would be the first new approach in nearly three decades. (iStock)<\/p>\n “I think this is promising,” Marc Siegel, M.D., senior medical analyst for Fox News, told Fox News Digital. “We really don’t have a very effective cream or lotion for hair loss<\/a>,” added the doctor, who was not involved in the study.<\/p>\n Minoxidil lotion, one of the most widely used, FDA-approved topical treatments, generally has limited effectiveness, Siegel noted. “So, this may well be valuable for widespread clinical use.”<\/p>\n Potential limitations and risks<\/p>\n Siegel, who was not involved in the trials, referenced the study\u2019s claim that the only side effect was “local irritation,” and said the medication appeared to be generally safe.<\/p>\n Safety and tolerance of the drug appeared to be comparable to the placebo group. Side effects were minimal and occurred at similar rates in both the active and placebo groups, with most found to be unrelated to the drug<\/a>, according to the researchers.<\/p>\n CLICK HERE TO DOWNLOAD THE FOX NEWS APP<\/strong><\/a><\/p>\n The researchers noted that the improvement in the study participants was in comparison to the placebo group in the study \u2014 it doesn\u2019t guarantee that men will grow five times more hair than with other treatments.<\/p>\n Safety outcomes for the medication were similar to placebo, with no unexpected adverse effects, the researchers said. (iStock)<\/p>\n Each individual’s results depend on how much hair they had at the start, and without the full data, it’s unclear how much visible growth most men will achieve.<\/p>\n CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER<\/strong><\/a><\/p>\n “You do need to watch out for allergic reactions<\/a>, and in rare cases, adrenal insufficiency, since the cream is an anti-androgen,” Siegel cautioned. This means because this treatment blocks androgens (male hormones), it could slightly affect the adrenal glands, which help the body manage stress hormones.<\/p>\n Full data, including long-term results and detailed absolute hair-count changes, are still pending regulatory review. (iStock)<\/p>\n Also, these are top-line results, as more detailed data \u2014 including long-term durability, variation between different degrees of hair loss and extended safety over 12 months \u2014 have yet to be released.<\/p>\n TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ<\/strong><\/a><\/p>\n If approved, this would be the first scalp treatment that works by blocking DHT right at the hair follicle \u2014 the first of its kind made specifically for male hair loss<\/a>, the company says.<\/p>\n![\"Man](\"https:\/\/www.europesays.com\/us\/wp-content\/uploads\/2025\/12\/man-looking-at-hair-in-mirror.jpg\")
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