Explained: How An Acne Drug Can Treat Male Pattern Baldness

Hair loss has frustrated millions of men worldwide for decades, with few truly novel treatments emerging beyond minoxidil and oral anti-androgens. But 2025 may mark a turning point. A company-backed announcement (made by Cosmo Pharmaceuticals on November 31, 2025) reveals that Clascoterone, an anti-androgen first approved for acne, has delivered "strong hair-growth results" in two large Phase III trials involving men with male pattern baldness (androgenetic alopecia, AGA). If regulatory approval follows, this could be the first major advance in topical hair-loss therapy in 30 years.

Since Clascoterone acts locally to block dihydrotestosterone (DHT) at the scalp, the hope is it provides hair-restoration benefits without the systemic hormonal side-effects associated with oral anti-androgens like finasteride. Here's a deeper dive into how Clascoterone works, what the trials show, and what its promise and limitations mean for patients seeking a real solution to pattern baldness.

How Clascoterone Works: Blocking Male Pattern Baldness

Dihydrotestosterone (DHT), derived from testosterone, is widely implicated in male pattern baldness. In genetically predisposed men, DHT binds to androgen receptors (ARs) in scalp hair-follicle dermal papilla cells, triggering a cascade that gradually miniaturizes hair follicles, shortens the growth phase and leads to thinning and hair loss. 

Clascoterone (also known as Cortexolone 17alpha-propionate, CB-03-01) is a topical anti-androgen, a rare one that acts directly in the skin. Studies show that when applied to the scalp, it competitively binds to those same ARs, blocking DHT binding. This prevents androgen-driven follicle miniaturisation without altering systemic hormone levels. 

Because its action is local and metabolism is rapid, systemic absorption, and thus risk of systemic side-effects, is minimal. This pharmacological profile differentiates Clascoterone from oral DHT-lowering drugs, which often carry risks such as sexual side-effects.

Also Read: Can A Serum Regrow Hair In 20 Days? New Study Says Yes, With Caution

What The Recent Phase III Trials Found And Why It Matters

The recent topline data, announced by Cosmo Pharmaceuticals in late 2025, come from two identical, randomized, double-blind, placebo-controlled Phase III trials of Clascoterone 5% topical solution in men with AGA.

• One trial reported a 539% relative increase in "target-area hair count (TAHC)" compared with placebo over six months. The second showed a 168% relative gain.
• According to the company, differences in relative improvement are driven by baseline hair counts, not by variability in drug performance.
• Importantly, the safety profile was favourable. Local skin reactions were comparable to placebo, and limited systemic exposure was observed.
• Experts associated with Cosmo Pharmaceuticals call this a potentially "fundamentally better treatment paradigm" for AGA.

This could mark the first time in three decades that a topical anti-androgen with a new mechanism enters the hair-loss market, a major shift for a condition long treated only with follicle stimulants (minoxidil) or systemic DHT blockers (finasteride, dutasteride) which carry systemic risks.

Why Clascoterone May Prove Safer And More Patient-Friendly

Because Clascoterone acts locally and is metabolised quickly, the risk of systemic hormonal side-effects seems low, and this is a major advantage over oral drugs. Clinical data from acne trials showed no significant suppression of systemic hormone (HPA axis) markers, even after weeks of application. 

Topical application also means patients avoid daily pills, instead using a scalp solution, likely improving compliance and reducing stigma or worry associated with systemic anti-androgen therapy.

Moreover, by targeting androgen receptor signalling directly at the scalp, Clascoterone may help preserve the body's hormonal balance elsewhere while addressing hair loss locally. This is a balance many specialists say has been elusive until now.

But Caution Remains: What We Still Don't Know

Despite the headline-grabbing relative gains, several important caveats remain:

• Absolute hair gain may be modest: Relative improvements like "539%" can be misleading unless the baseline hair count is known. For example, a rise from 10 to 60 hairs yields 500% increase but may still leave visible thinning. Indeed, commentators in dermatology and hair-loss forums argue that relative percentages should be interpreted cautiously.
• Long-term effects not yet established: The trials ran for 6 months, with an open-label extension. Long-term sustainability, safety, and whether follicles remain healthy over years remain to be studied.
• Regulatory approval still pending: Although Clascoterone is FDA-approved for acne (1% cream, brand name Winlevi), its use for hair loss (at higher 5% concentration) remains experimental until regulatory agencies worldwide evaluate the Phase III data.
• Not all hair-loss types respond: Because AGA has a strong genetic component and involves follicle miniaturization due to DHT sensitivity, Clascoterone's benefit will likely be limited to androgen-dependent pattern baldness, not hair loss due to autoimmune disease, nutritional deficiency or scarring conditions.

Dermatology literature has previously noted that while Clascoterone's mechanism suggests plausibility, robust human data remain limited, and more independent clinical trials are needed to confirm effectiveness for hair regrowth.

Also Read: Male Pattern Baldness: How To Spot It Early And What You Can Do

What This Means For Patients Now

For men dealing with early- to mid-stage male pattern baldness, Clascoterone, once approved, could offer a safer, more convenient topical alternative to pills. It may appeal especially to those who:

• Want to avoid potential systemic side-effects of oral anti-androgens.
• Prefer a topical, scalp-focused therapy.
• Have started experiencing thinning or receding hairlines but still have some hair, since early intervention generally yields better results.

However, patients and prescribers alike should manage expectations realistically. This is not yet a guaranteed "cure" and results, when expressed as relative percentage gains, may translate into incremental regrowth or density improvement rather than full restoration.

Clascoterone's 2025 Phase III trial results represent perhaps the most promising development for male pattern baldness in decades. By offering a novel topical anti-androgen mechanism that targets DHT locally in the scalp, potentially without systemic hormonal side-effects, it may transform how we treat androgenetic alopecia.

That said, relative hair-count gains and limited duration of trials counsel caution. Until long-term data and regulatory approvals arrive, Clascoterone remains a hopeful breakthrough, but not a miracle cure. For now, it offers a compelling new option for those seeking a safer, scalp-focused approach to hair loss, and a reason to re-examine assumptions about what's possible in hair-regrowth therapy.

Disclaimer: This content including advice provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.