Recently published results from two identical Phase III clinical trials highlight the promise of a new hair loss treatment: clascoterone 5% topical solution.
In this blog, we’ll explain how clascoterone 5% works to stop male hair loss, the results of the latest clinical trials, plus why this treatment is so exciting.
What is Clascoterone 5%?
Clascoterone 5%, otherwise known as ‘Breezula’, is a topical solution which is currently being researched as a new treatment for androgenetic alopecia (male pattern baldness). It works through a new mechanism targeting hair follicles differently to current treatments on the market.
Male pattern baldness is caused by a male hormone (androgen) called dihyrdrotestosterone (DHT), which binds to receptors on the hair follicles and causes them to shrink. DHT also shortens the growth (anagen) phase of hair. This process turns thick, pigmented hairs (terminal hairs) into thin, fine hairs (vellus hairs), leading to bald spots.
The clascoterone molecule has a similar structure to DHT, so it binds to androgen receptors on hair follicles instead of DHT. By blocking DHT from binding to the follicles, this may protect them from shrinkage and support hair regrowth.
ex vivostudy, aka a lab study, compared clascoterone 5% to minoxidil 5% using hair follicle biopsies from five men. Both treatments increased the ability of hair cells to form and maintain new follicles and stimulated hair shaft production. Interestingly, clascoterone also reduced IL-6, a growth-inhibiting factor, more effectively than Minoxidil.
While encouraging, these results are based on limited and short-term data.
At the end of 2025, two Phase-III human clinical trials were completed. 1,465 participants were randomly allocated to two identical trials, which were called SCALP1 (NCT05910450) and SCALP2 (NCT05914805) respectively. Both trials showed statistically significant improvements in total hair count: 539% in SCALP1 and 168% in SCALP2. The difference between the two trials is unexpected, given their identical design.
The safety profile was positive, with a mandatory 12-month safety profile due to be completed in spring 2026. After this, applications for regulatory approval in the US and Europe are expected to follow.
How does it compare to current treatments?
Currently, only Finasteride 1mg tablets and Minoxidil 5% spray are licensed for the treatment of androgenetic alopecia in the UK and Ireland. Other formulations of both, e.g Finasteride spray and Minoxidil Capsules, are also prescribed off-label as treatment where suitable. Both finasteride and minoxidil have been about for decades and widely used to treat male pattern baldness, with lots of clinical data to back up their efficacy and safety.
However, some men who would like to treat their hair loss are worried by the impact of oral finasteride on their hormones (as it directly fights male hair loss by reducing DHT levels), which they worry will impact their sexual performance. We have a dedicated article separating the fact from fiction on this topic, which you can read here.
Clascoterone 5% solution could fill this gap by offering a treatment option to men who avoid finasteride and dutasteride due to concerns about hormonal side effects, by directly targeting hair follicles without affecting hormone levels.
Although it’s not available yet, it could be a promising addition to the hair loss treatment landscape and offer a new option to help more men treat hair loss.
All of our blog articles are reviewed by our Medical Director before publication.
