How long does it take for clascoterone to show results on hair growth?

Clascoterone, also known as CB-03-01 or by its investigational brand name Breezula, is a topical antiandrogen developed specifically to target hair loss conditions like androgenetic alopecia (AGA). This compound functions by blocking androgen receptors in the skin, which helps to locally inhibit the effects of dihydrotestosterone (DHT), a hormone strongly implicated in hair follicle miniaturization and thinning. Unlike oral medications such as finasteride that lower systemic DHT levels throughout the body, clascoterone acts only where it's applied—most often the scalp—minimizing the potential for widespread hormonal side effects. This distinction is particularly important for patients seeking a treatment with a lower systemic risk profile.

When do results start to appear?

Clinical trials investigating clascoterone for hair regrowth have used varying concentrations (commonly 5% and 7.5%) across different demographics, including adult men and women. The data from these trials reveal that:

Around 6 months of consistent use are needed before a noticeable increase in terminal hair count (i.e., thick, pigmented hairs rather than miniaturized, vellus hairs) becomes evident.
By 12 months, more sustained and visible improvements in hair density and scalp coverage can be observed.

For example, a 6-month phase II trial in women demonstrated that females under the age of 30 experienced a statistically significant increase in terminal hair count when treated with 5% topical clascoterone compared to a placebo. In other subgroups—such as older women and those using different concentrations—the improvements trended positively but didn’t reach statistical significance. These outcomes suggest that the response to clascoterone may vary based on age, hormonal profile, and possibly the duration of the condition. However, the general consensus among researchers is that visible results typically begin between 4 to 6 months, with meaningful, sustained improvement often becoming more prominent between 6 to 12 months. It’s essential that users apply the product consistently, as interruptions can significantly delay or diminish the therapeutic effect.

Differences by type of alopecia

While clascoterone appears promising for androgenetic alopecia (AGA), it’s important to understand that not all hair loss disorders are influenced by androgens—**and thus not all types respond to antiandrogen treatments: **

Androgenetic Alopecia (AGA): This is the most common form of hair loss in both men and women and is directly influenced by the effects of DHT on scalp hair follicles. Clascoterone’s DHT-blocking mechanism helps to reverse miniaturization of follicles and prolong the anagen (growth) phase. Most of the available clinical evidence surrounding clascoterone has been conducted in AGA patients, demonstrating promising outcomes in this population.
Alopecia Areata or Universalis: These are autoimmune conditions in which the immune system attacks the hair follicles. The role of androgens in these diseases is minimal or nonexistent. Consequently, clascoterone is not considered an effective treatment for alopecia areata, and other therapies, such as corticosteroids or Janus kinase (JAK) inhibitors, are typically used instead.
Scarring Alopecias or Traction Alopecia: These conditions involve permanent damage to the follicle, often due to inflammation, injury, or prolonged mechanical stress. Once follicles are destroyed or scarred, hair regrowth becomes extremely difficult or impossible without surgical intervention. As clascoterone targets hormonal pathways and not regenerative or inflammatory ones, it is unlikely to offer any benefit in these scenarios.

This distinction is important for patients and practitioners alike. Understanding the root cause of hair loss is key to selecting an appropriate treatment—and clascoterone’s benefits seem limited to hormonal, non-scarring forms of alopecia.

Current clascoterone-based treatments in development

Despite its approval by the FDA in 2020 for the treatment of acne (under the brand name Winlevi), clascoterone has not yet been officially approved for treating hair loss. However, multiple studies and clinical trials are underway to evaluate its potential for androgenetic alopecia:

Phase III Trials in Men: Two large-scale studies, known as SCALP1 and SCALP2, began in June 2023 and aim to evaluate the long-term efficacy and safety of clascoterone in approximately 1,500 adult men. These trials are scheduled to run for 6 to 12 months and are expected to provide critical data for regulatory approval.
Phase II Trials in Women: A multicenter, double-blind study conducted in Germany compared the effects of 5% and 7.5% clascoterone solutions to both minoxidil and placebo in female patients. The trial lasted 6 months and showed that clascoterone was well tolerated. Notably, women under 30 experienced statistically significant increases in terminal hair count, though broader population results were more variable.

These studies are crucial in determining not just whether clascoterone works, but also for whom, at what concentration, and under what treatment conditions. As more data becomes available, treatment protocols will likely be refined to optimize results.

Comparison with other topical treatments

To better understand clascoterone’s position in the therapeutic landscape, it’s useful to compare it to other topical options currently used to treat androgenetic alopecia:

Minoxidil: Approved for both men and women, minoxidil is a vasodilator that prolongs the anagen phase of hair follicles. Results typically appear within 3 to 6 months. It is considered a first-line therapy but does not address the hormonal cause of hair thinning.
Finasteride (topical and oral): Finasteride inhibits the enzyme 5-alpha-reductase, which converts testosterone to DHT. While the oral form is highly effective, it comes with the risk of systemic side effects. Topical finasteride offers a localized alternative with similar outcomes, but efficacy data is still emerging. Results often appear between 3 and 6 months.
Ketoconazole 2% Shampoo: Though primarily an antifungal agent, ketoconazole may offer mild antiandrogenic effects and is often used as an adjunct therapy. It can improve scalp health and reduce inflammation, indirectly supporting hair growth.

Clascoterone distinguishes itself by directly blocking DHT at the receptor level in the skin, offering a complementary or alternative option to finasteride without altering hormonal levels in the bloodstream. This localized mechanism may make it a more appealing choice for patients concerned about systemic effects, particularly women of reproductive age.

Hair growth stages and expected outcomes

Hair growth follows a well-established cycle composed of three main stages:

Anagen (Growth Phase): This is the active growth period of hair follicles, lasting several years. The goal of most treatments, including clascoterone, is to prolong this phase, allowing for thicker and longer hair. Clinical evidence suggests that consistent use of clascoterone over 6 to 12 months can help transition more follicles into this growth phase.
Catagen (Transition Phase): A brief period when hair growth slows and the follicle begins to shrink. This stage typically lasts only a few weeks and is not a direct target of therapeutic intervention.
Telogen (Resting/Shedding Phase): During this phase, hair stops growing and eventually falls out to make room for new growth. A high percentage of follicles in telogen is often associated with thinning. Treatments like clascoterone aim to reduce the duration of this phase by encouraging faster re-entry into anagen.

For patients with androgenetic alopecia, a successful response to treatment is typically marked by an increase in anagen hairs, a decrease in telogen hairs, and an overall improvement in hair thickness and density. These changes usually take several months to manifest, emphasizing the need for long-term commitment to therapy.

User Experiences

Topical clascoterone (marketed as Breezula for AGA) is emerging as a promising DHT-blocking treatment for androgenetic alopecia, particularly for those seeking alternatives to finasteride or RU58841. But how long does it actually take to see results? Insights from the Tressless community give us a clearer picture based on lived experience, experimentation, and real-world timelines. Many users report that clascoterone does not yield rapid results—patience is essential.

One notable post details a Phase 3 clinical trial in progress, where a user agreed to have a section of their scalp shaved and tattooed to monitor results over 6 months. They expected visible hair growth only toward the end of the trial, highlighting that even in structured research settings, clascoterone likely requires 3 to 6 months for visible change, consistent with most antiandrogen therapies. In broader community discussions, those incorporating clascoterone into multi-treatment regimens (often alongside minoxidil, topical finasteride, or tretinoin) observed improvements in density and reduced shedding between 4 to 5 months in. These results were typically attributed not just to clascoterone alone but to its synergy with other treatments, suggesting it may take time to stabilize hair loss before regrowth is noticeable.

A key point repeatedly raised is that results are not immediate and are often subtle in the early phases. Users testing it as a monotherapy or in cycles often report frustration in the first 2–3 months, only to note stabilization around month 4. The lack of systemic side effects makes it attractive for long-term use, but that also means it may act more slowly than oral drugs like finasteride or dutasteride.Some posts also mention hope around clascoterone as a safer, localized DHT inhibitor with minimal hormonal disruption, especially for those who experienced side effects from systemic treatments. However, community sentiment is clear: expectations should be managed, and at least 6 months of use is often necessary to evaluate effectiveness.

In summary, Tressless users indicate that clascoterone may take 4 to 6 months to show visible improvements in hair density, with earlier results being more about slowing or halting loss. Like most hair loss treatments, long-term consistency appears critical.

Clear conclusion

Clascoterone shows considerable promise as a targeted topical treatment for androgenetic alopecia, particularly in individuals who cannot tolerate systemic therapies or prefer a localized approach. While results are not immediate, consistent application—typically twice daily—is associated with meaningful improvements in hair density and follicular health over 6 to 12 months. However, its benefits appear to be specific to hormonally-driven, non-scarring types of alopecia.

As clinical trials continue, we expect clearer guidance on which patients will benefit most from clascoterone, what concentration offers the best results, and how it might be integrated with existing therapies like minoxidil or ketoconazole.

References

Cassiopea SpA. (2019, April 16). Cassiopea Announces Very Positive Phase II Twelve Months Results for Breezula® (Clascoterone) in Treating Androgenetic Alopecia [Press release]. Retrieved from https://bit.ly/2VnYourLink

Cosmo Pharmaceuticals N.V. (2023, June 29). Cosmo Announces the Beginning of the Phase III Trials in Males for the Treatment of Androgenetic Alopecia. Retrieved from https://bit.ly/YourPhase3Link

Koralewicz, M. M., & Szatkowska, O. A. (2024, July 25). Topical solutions for androgenetic alopecia: evaluating efficacy and safety. Forum Dermatologicum, 10(3), 71–78. Retrieved from https://bit.ly/YourJournalLink

https://reddit.com/r/tressless/comments/1cd9cxc/clascoterone_study_going_on_right_now/

https://reddit.com/r/tressless/comments/1fxk7up/the_ultimate_regimen_for_density_and_thick_ess/