New baldness treatment shows dramatic hair-regrowth gains in major trial

Health

New baldness treatment shows dramatic hair-regrowth gains in major trial

Clascoterone topical solution could be first major innovation for male pattern baldness in over 30 years, researchers say

Khloe Quill Fox News

Published

December 9, 2025 7:00am EST

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A new experimental scalp treatment called clascoterone has shown strong results in helping reduce male-pattern hair loss (also known as androgenetic alopecia, or AGA).

Experts call the results promising, claiming that 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 — named Scalp 1 and Scalp 2 — enrolled a combined total of 1,465 men across the U.S. and Europe, according to a press release.

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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.

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 rather than affecting hormones system-wide, according to Cosmo Pharmaceuticals.

Cosmo Pharmaceuticals reported strong phase 3 results for clascoterone in treating male-pattern hair loss. (iStock)

This localized approach attempts to address the biological root 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 with the placebo group. The participants in Scalp 2 showed a 168% relative improvement, the release stated.

"We really don't have a very effective cream or lotion for hair loss, so this 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 counted-hair results.

"For decades, patients have had to choose between available treatment options 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.

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"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.

Patient-reported outcomes — how study participants perceived their hair growth — were also positive.

man applies serum with a dropper to the top of his balding head

If approved, the treatment would be the first new approach in nearly three decades. (iStock)

"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," added the doctor, who was not involved in the study.

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."

Potential limitations and 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 medication appeared to be generally safe.

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, according to the researchers.

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The researchers noted that the improvement in the study participants was in comparison to the placebo group in the study — it doesn’t guarantee that men will grow five times more hair than with other treatments.

Safety outcomes for the medication were similar to placebo, with no unexpected adverse effects, the researchers said. (iStock)

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.

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"You do need to watch out for allergic reactions, 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.

Full data, including long-term results and detailed absolute hair-count changes, are still pending regulatory review. (iStock)

Also, 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 yet to be released.

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If approved, this would be the first scalp treatment that works by blocking DHT right at the hair follicle — the first of its kind made specifically for male hair loss, the company says.

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Cosmo plans to complete a full 12-month safety follow-up by spring 2026 before submitting the medication for regulatory approval in the U.S. and Europe.

Khloe Quill is a lifestyle production assistant with Fox News Digital. She and the lifestyle team cover a range of story topics including food and drink, travel, and health.

New baldness treatment shows dramatic hair-regrowth gains in major trial