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Clascoterone & Hair Loss: Does It Work & Is It Safe?

Clascoterone & Hair Loss: Does It Work & Is It Safe?

clascoterone hair loss

Would you consider using clascoterone to treat hair loss?

Clascoterone could become a new, well-tolerated topical solution for male pattern baldness, offering DHT-blocking benefits without finasteride’s systemic side effects. Early trials suggest meaningful hair regrowth and strong safety signals. If ongoing research confirms its effectiveness, it may soon emerge as a widely accessible, non-surgical hair restoration option.

Executive summary

Find out what clascoterone is, how it works for hair loss, and what current research reveals about clascoterone’s effectiveness and safety as a hair loss drug. Learn how it compares with finasteride and minoxidil, who might benefit most, and how you can get clascoterone for hair loss in the UK.

Key takeaways

  • Clascoterone is an anti-androgenic drug that stops dihydrotestosterone from binding to receptors in the hair follicle, potentially preventing shrinkage linked to male pattern baldness.

  • Early phase II and III trials into clascoterone for hair loss showed significant hair count improvements and good safety results. One study with 700+ participants showed a 539% increase in hair count compared with placebo, while another showed a 168% improvement [1].

  • However, most major studies into clascoterone for hair loss have been funded by the manufacturer, so independent research is essential to confirm their findings.

  • Clascoterone differs from finasteride by acting locally without reducing overall DHT levels. It may help reduce hair loss without causing systemic side effects.

  • As of 2026, clascoterone is only licensed to treat acne. Using clascoterone for hair loss use requires off-label prescription.

What is clascoterone?

Clascoterone is an anti-androgenic drug, which means it inhibits the impact of certain male sex hormones to alleviate symptoms associated with high androgen levels. It was approved as a topical treatment for acne in the UK in 2025, and has also been approved by regulatory bodies in the US, Canada, France, and Australia.

Because clascoterone can reduce your androgen levels, it has also been touted as a treatment for male pattern baldness. Male pattern baldness is largely caused by high sensitivity to or high levels of dihydrotestosterone (DHT), a male sex hormone.

Is clascoterone an effective treatment for hair loss?

Clascoterone is a relatively new drug, so the evidence for its success as a hair loss treatment is still quite limited [1-4]. Early study results are promising, with phase III clinical trials showing that clascoterone effectively reduces symptoms of androgenetic alopecia, and has a relatively good safety profile [1].

Phase II trials found clascosterone to be more effective than the anti-androgenic drugs cyproterone acetate and 17α-estradiol in promoting hair follicle density and hair shaft diameter [5].

That said, the largest trials so far have been conducted by Cosmo, the pharmaceutical firm behind clascoterone [1, 3]. More large-scale independent studies are needed to confirm their findings. But if further research does find clascoterone to be safe and effective for treating male pattern baldness, it could become a widely-used hair loss solution.

Two phase III clinical trials from Cosmo Pharmaceuticals have found clascoterone to be safe and effective as a treatment for androgenetic alopecia. The studies enrolled 1,465 men aged 18 or over, who were required to apply a topical cream containing 5% clascoterone to their scalp twice a day for 6 months [1].

Those who responded positively to treatment were required to continue applying clascoterone 5% cream for a further 6 months to test long-term safety and effectiveness.

Both studies showed a marked improvement in hair loss over the course of the trial. The first study found clascoterone 5% cream improved hair count by 539% compared with a placebo, while the second showed a 168% improvement.

There was no significant difference in adverse effects between the treatment group and the placebo group, indicating a good safety profile in clascoterone.
Lab studies, phase I and phase II studies have also indicated that clascoterone may help reduce hair loss in those with male pattern baldness [2-4].

How does clascoterone for hair loss work?

Clascoterone is an anti-androgenic drug, which means it reduces activity of androgens (male sex hormones) in the body. Dihydrotestosterone, or DHT, is an androgen that has been linked with the development of male pattern baldness. DHT binds to androgen receptors in the hair follicles, causing them to shrink and eventually stop producing hair.

DHT Impact On Hair

Clascoterone works by stopping DHT from binding to the androgen receptors in the follicles. Clascoterone has a similar structure to DHT, which allows it to bind to those receptors itself. This prevents DHT from binding to the receptors and causing the follicle to shrink [2].

Clascoterone vs finasteride: what’s the difference?

Finasteride is the most effective non-surgical treatment for male pattern baldness that’s been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). Like clascoterone, it works by limiting the impact of DHT on the hair follicle — but unlike clascoterone, finasteride has also been shown to cause systemic side effects in some users, which makes some men wary about using it [6].

The difference in side effects from finasteride vs clascoterone is likely due to their mechanisms of action. Clascoterone is a topical cream that doesn’t actually reduce the amount of DHT in your body; it just stops it binding to your hair follicles.

Finasteride, on the other hand, is mostly taken as an oral medication that reduces the activity of the 5-alpha reductase enzyme, which causes the body to produce less DHT. Many of the sexual and psychological side effects of finasteride are due to the reduced levels of DHT circulating in the body [2, 6].

Topical finasteride has also been shown to reduce hair loss while offering a lower risk of systemic side effects [7]. No studies have yet directly compared the impact of topical finasteride versus clascoterone, but finasteride has been shown to achieve a relative hair count improvement of 200% (compared with placebo). This is comparable with the results of the second clascoterone trial, which achieved a 168% improvement in hair count. Finasteride was applied once-daily, while clascoterone was applied twice daily.

Finasteride has been widely studied and is still deemed very safe and well-tolerated for most users. Clascoterone has been deemed safe as an acne treatment, but it’s still in the trial phase as a hair loss solution. So there may be side effects or tolerability issues that haven’t yet surfaced.

Is clascoterone available for patients with hair loss?

As of 2026, clascoterone is only licensed as a treatment for acne vulgaris in the UK. So patients looking to use clascoterone to deal with their receding hairline or crown hair loss won’t be able to get it just yet, unless it’s prescribed off-label by a doctor.

Cosmo Pharmaceuticals have said they’re exploring options to license clascoterone for hair loss, but it’s unclear how soon this could happen, and whether the UK’s MHRA would be early to approve it. (The MHRA approved clascoterone as an acne treatment 5 years later than the USA’s FDA.)

If you’re interested in using clascoterone for hair loss, speak to a trichologist. They may be able to prescribe clascoterone off-label, or advise you about alternative hair loss treatments. The Wimpole Clinic offers trichology appointments around the UK, where you can discuss your hair concerns with a qualified hair doctor.

Book a consultation to get a hair and scalp assessment, and discuss your treatment options.

Who can use clascoterone for hair loss?

Clinical trials on clascoterone for hair loss have focused exclusively on male patients over the age of 18. So if it is approved for hair loss, it’s only likely to be licensed for men.

It’s unclear whether all men with male pattern baldness would benefit from clascoterone treatment. Typically, men in the early stages of hair loss see better hair retention when using non-surgical treatments than those with more advanced baldness. The Norwood Scale measures the progression of male pattern baldness:

Norwood scale 1

Is clascoterone safe for women?

Clascoterone may be safe for women to use. Studies exploring the use of clascoterone for acne have tested the drug on women and girls, and have found mostly mild side effects including facial redness and skin dryness [8-9]. However, one clinical study did report rare instances of polycystic ovaries and amenorrhea in female patients using clascoterone to treat acne [10].

Studies into clascoterone for female hair loss haven’t shown great promise so far. One study of 61 women compared the efficacy of 5% and 7.5% clascoterone with 2% minoxidil [11]. While 75% of subjects saw increased hair growth using minoxidil, 57% and 66% of subjects experienced improved hair growth using 5% clascoterone and 7.5% clascoterone respectively.

So according to results from this small study, women with hair loss may be better off using minoxidil for women, which has been studied extensively and shown to be effective for female users [12-13].

What are the side effects of clascoterone?

According to current evidence, the side effects of clascoterone are normally mild and minimal. The most common known side effects of clascoterone (when used to treat acne) include:

  • Swelling
  • Redness
  • Itchiness, scaling, and dryness

Other patients reported thinning skin, striae rubrae (the appearance of stretch marks), and telangiectasia (the appearance of spider veins). These side effects were less common, reported by fewer than 2.5% of patients in one clinical study [10].

Another found similar common side effects, as well as hyperkalemia (high potassium levels in the blood), polycystic ovaries and amenorrhea, though these were rare [10].

Clascoterone for acne is typically tested and licensed at a concentration of 1%. Trials exploring clascoterone for hair loss are testing the drug at a 5% concentration, which may increase the risk of side effects.

How to use clascoterone for hair loss

There’s no official guidance on how to use clascoterone for hair loss at present. In the largest clinical trials to date, participants applied a 5% clascoterone cream to their scalp twice a day.

If you’re prescribed clascoterone for hair loss, make sure to follow the instructions from your prescribing doctor. Applying the cream more or less often than recommended may increase the risk of side effects, or reduce its effectiveness.

Clascoterone vs minoxidil

Clascoterone and finasteride aren’t the only non-surgical hair loss treatments out there. Minoxidil is another licensed treatment for male pattern baldness, as well as other types of alopecia.

Like clascoterone, minoxidil is a topical treatment for hair loss. Available in 5% and 2% concentrations, most users are advised to apply minoxidil to their thinning areas twice a day. Minoxidil doesn’t affect your DHT levels; it works by widening the blood vessels in the scalp, allowing more blood, nutrients, and oxygen to feed the hair follicles.

No studies have compared the impact of clascoterone vs minoxidil, so it’s unclear which treatment is generally more effective. Because both treatments are topical, neither should cause systemic side effects.

Explore hair loss treatments at the Wimpole Clinic

At the Wimpole Clinic, we believe in treating every patient as an individual. So if you haven’t yet found the right formula to tackle your hair loss — whether it’s male pattern baldness, alopecia areata, or stress-related alopecia — we’re here to help.

Voted Hair Transplant Clinic of the Year four years running, we’re trusted by thousands of patients to help tackle their hair loss every year. For many patients, this involves both surgical and non-surgical routes to hair restoration, including specific proven off-label medications.

To find out more about restoring your hair at the Wimpole Clinic, book a free consultation at your most convenient clinic location.

Clascoterone & Hair Loss: Does It Work & Is It Safe?, Wimpole Clinic

FAQs

Find out more about using clascoterone to treat hair loss in these frequently asked questions.

Breezula is the brand name of clascoterone 5% cream. It’s often used interchangeably with ‘clascoterone’ to describe the drug currently being investigated as a hair loss treatment.

Winlevi is the brand name of clascoterone 1% cream that’s licensed to treat acne vulgaris.

No studies have compared the effectiveness of clascoterone vs finasteride for hair loss, so it’s unclear which is more likely to reduce symptoms of hair loss.

That said, finasteride has decades of evidence to support its use, while clascoterone is still a relatively new drug, and hasn’t yet been licensed to treat hair loss. So finasteride is usually recommended as a first-line treatment, while doctors may be hesitant to prescribe clascoterone for hair loss at this stage.

No evidence has conclusively shown when to expect hair loss improvements from clascoterone. However, large phase III clinical trials collected enough data to determine if a participant had responded to clascoterone treatment within 6 months.

Yes, clascoterone is available in the UK, though it’s not yet licensed as a hair loss treatment. It is available on prescription to treat acne in people aged 12 and above.

Sources:
  1. Cosmo Pharmaceuticals N.V. (2026, April 15). Phase III 12-Month data for clascoterone 5% topical solution confirm positive safety for chronic use and continued hair growth, both of which are statistically significant. Cosmo Health Confidence. https://www.cosmohealthconfidence.com/news/98958067-clascoterone-12-month-safety-results-ende.
  2. Sun, H. Y., & Sebaratnam, D. F. (2020). Clascoterone as a novel treatment for androgenetic alopecia. Clinical and Experimental Dermatology, 45(7), 913–914. https://doi.org/10.1111/ced.14292.
  3. Cartwright, M., Mazzetti, A., Moro, L., Rosette, C., & Gerloni, M. (2019). A summary of in vitro, phase I, and phase II studies evaluating the mechanism of action, safety, and efficacy of clascoterone (cortexolone 17a propionate, CB-03-01) in androgenetic alopecia. Journal of the American Academy of Dermatology, 81, AB13. https://doi.org/10.1016/j.jaad.2019.06.087.
  4. Rosette, C., Rosette, N., Mazzetti, A., Moro, L., & Gerloni, M. (2019). Cortexolone 17α-Propionate (Clascoterone) is an Androgen Receptor Antagonist in Dermal Papilla Cells In Vitro. Journal of drugs in dermatology : JDD, 18(2), 197–201.
  5. Devjani, S., Ezemma, O., Kelley, K. J., Stratton, E., & Senna, M. (2023). Androgenetic Alopecia: Therapy Update. Drugs, 83(8), 701–715. https://doi.org/10.1007/s40265-023-01880-x.
  6. Estill, M. C., Ford, A., Omeira, R., & Rodman, M. (2023). Finasteride and dutasteride for the treatment of male androgenetic alopecia: A review of efficacy and reproductive adverse effects. Georgetown Medical Review, 7(1). https://doi.org/10.52504/001c.88531.
  7. Piraccini, B. M., Blume-Peytavi, U., Scarci, F., Jansat, J. M., Falqués, M., Otero, R., Tamarit, M. L., Galván, J., Tebbs, V., Massana, E., & Topical Finasteride Study Group (2022). Efficacy and safety of topical finasteride spray solution for male androgenetic alopecia: a phase III, randomized, controlled clinical trial. Journal of the European Academy of Dermatology and Venereology : JEADV, 36(2), 286–294. https://doi.org/10.1111/jdv.17738.
  8. Hebert, A., Thiboutot, D., Stein Gold, L., Cartwright, M., Gerloni, M., Fragasso, E., & Mazzetti, A. (2020). Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA dermatology, 156(6), 621–630. https://doi.org/10.1001/jamadermatol.2020.0465.
  9. Cross, C. E. (2026). Clinical significance and early experience of clascoterone in the treatment of acne vulgaris. EMJ Dermatology, 14(Suppl 2), 2–9. https://doi.org/10.33590/emjdermatol/NFMN1794.
  10. Medicines and Healthcare products Regulatory Agency. (2025). Winlevi 10 mg/g cream (clascoterone): Patient information leaflet.
  11. European Medicines Agency. (2022). EudraCT Number 2019-000950-78: A phase II, multicenter, prospective, randomized, double-blind, minoxidil and vehicle controlled, dose-ranging study to evaluate the efficacy and safety of CB-03-01 (Cortexolone 17α-propionate) solution for the treatment of androgenetic alopecia in females (Results summary). EU Clinical Trials Register. Retrieved April 15, 2026, from https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000950-78/results.
  12. Lucky, A. W., Piacquadio, D. J., Ditre, C. M., Dunlap, F., Kantor, I., Pandya, A. G., Savin, R. C., & Tharp, M. D. (2004). A randomized, placebo-controlled trial of 5% and 2% topical minoxidil solutions in the treatment of female pattern hair loss. Journal of the American Academy of Dermatology, 50(4), 541–553. https://doi.org/10.1016/j.jaad.2003.06.014.
  13. Ramos, P. M., Sinclair, R. D., Kasprzak, M., & Miot, H. A. (2020). Minoxidil 1 mg oral versus minoxidil 5% topical solution for the treatment of female-pattern hair loss: A randomized clinical trial. Journal of the American Academy of Dermatology, 82(1), 252–253. https://doi.org/10.1016/j.jaad.2019.08.060

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