Clascoterone is a newer topical antiandrogen that has attracted growing attention in dermatology for its targeted mechanism of action and favorable safety profile.
Originally developed and FDA-approved for the treatment of acne, clascoterone works by locally blocking androgen receptors in the skin without significant systemic hormone suppression.
This same androgen-inhibiting activity has positioned clascoterone as a promising option for hair loss, particularly androgenetic alopecia, when formulated at higher strengths designed to act directly at the scalp level.
What Is Clascoterone?
Clascoterone is a first-in-class topical androgen receptor inhibitor developed to treat hormonally driven skin conditions. It is a synthetic steroidal molecule structurally related to progesterone, designed to act locally within the skin rather than systemically.
Clascoterone is marketed under the brand name Winlevi® as a 1% cream and received FDA approval in August 2020 for the topical treatment of acne vulgaris in patients aged 12 and older. Its development represented a significant advancement in targeted antiandrogen therapy.
Intended Purpose of Clascoterone Cream
The primary indication for clascoterone cream is the treatment of acne vulgaris, a condition in which excess androgen signaling increases sebum production and drives inflammation.
Clascoterone is highly effective because it directly blocks androgen receptors within sebaceous glands, reducing sebum output without altering circulating hormone levels.
This localized action minimizes systemic side effects commonly associated with oral antiandrogens, making clascoterone particularly well-suited for long-term dermatologic use in both male and female patients.
How Clascoterone Works
Clascoterone exerts its effects by targeting androgen signaling directly within the skin, a key driver of both acne and androgen-related hair loss.
Unlike systemic antiandrogens that reduce circulating hormone levels, clascoterone acts locally at the tissue level, where androgens such as dihydrotestosterone (DHT) bind to receptors and trigger biological changes.
Once applied, clascoterone competes with androgens for receptor binding, limiting their ability to activate gene transcription involved in sebum production, inflammation, and follicular miniaturization.
This localized mechanism allows for targeted androgen suppression at the skin and scalp while preserving normal endocrine function throughout the body.
Androgen Receptor Inhibition
Clascoterone functions as a competitive antagonist at androgen receptors within skin structures, including sebaceous glands and hair follicles.
By preventing DHT and testosterone from binding to these receptors, clascoterone interrupts androgen-driven signaling pathways that contribute to inflammation and progressive miniaturization seen in androgenetic alopecia (AGA).
Clascoterone does not inhibit androgen production or alter systemic hormone metabolism.
Instead, it reduces androgen activity only where it is applied, allowing dermatologists to address hormone-sensitive conditions at their source while avoiding the endocrine disruption associated with oral antiandrogens.
Local Versus Systemic Absorption
A defining feature of clascoterone is its minimal systemic absorption and rapid metabolism within the skin. After topical application, clascoterone is quickly converted into inactive metabolites that lack antiandrogenic activity once they enter systemic circulation.
When used for the treatment of acne, no clinically meaningful effects on serum testosterone, cortisol, or other hormonal markers have been found.
This pharmacokinetic profile is particularly relevant for scalp use, as it supports repeated, long-term application while minimizing the risk of systemic side effects often associated with oral hormone-modulating therapies.
Breezula: New Clascoterone Hair Loss Solution
Breezula® is an investigational topical formulation of clascoterone being developed specifically for androgenetic alopecia (pattern hair loss).
Unlike the 1% clascoterone cream approved for acne, Breezula® is a higher-strength solution (5% and other concentrations) designed to target androgen receptors in the scalp to reduce DHT-mediated follicle miniaturization.
If approved, Breezula® would be the first topical androgen receptor inhibitor indicated for hair loss, offering a novel, non-systemic approach that directly addresses the hormonal component of pattern hair loss.
Evidence for Hair Regrowth
Clinical research on clascoterone for hair loss shows promising results, particularly for male androgenetic alopecia.
The medication targets the same hormonal pathways that cause pattern baldness, making it a logical treatment option. Studies demonstrate that higher concentrations of clascoterone can promote hair regrowth by protecting follicles from DHT damage.
Phase 3 Trial Results
Two pivotal Phase III trials of clascoterone 5% topical solution for male androgenetic alopecia conducted by Cosmo Pharmaceuticals showed promising results.
A total of 1,465 patients enrolled in two identically designed Phase III studies conducted in the United States and Europe, each with a 6-month treatment phase. Some participants were given a placebo, while the others were given clascoterone 5% solution.
One study demonstrated a 539% relative improvement in target-area hair count versus the placebo group, while the second study showed a 168% relative improvement compared to those receiving a placebo.
The different results in the two studies could be due to baseline disease severity, regional demographics, or site-level differences in assessment technique, but variations such as this are considered normal in studies of this nature.
The main point is that both studies showed significant hair growth improvement, positive patient-reported outcomes, and a positive safety profile.
Following the studies, Giovanni Di Napoli, CEO of Cosmo, stated:
“For the first time in more than thirty years, we have a completely new mechanism with the potential to truly change that reality.”
“With strong efficacy across the two largest Phase III studies, and a favorable safety profile, clascoterone 5% topical solution opens the door to a fundamentally better treatment paradigm for patients.”
Looking Ahead
Cosmo plans to complete the required 12-month safety follow-up in spring 2026. Upon completion of all required trials and data submissions, Cosmo plans to promptly pursue regulatory submissions in both the United States and Europe.
Thanks to this recent research, clascoterone 5% topical solution is positioned to become the first topical androgen receptor inhibitor ever approved for AGA.
While waiting for Breezula's approval, many choose personalized topical solutions containing proven ingredients such as finasteride or dutasteride combined with minoxidil through Happy Head, which offers close to 200 personalized prescription formulations.
Clascoterone vs. Spironolactone
Clascoterone and spironolactone both target androgen signaling, a key driver of androgenetic hair loss, but they differ in formulation, scope of action, and patient considerations.
Spironolactone, a prescription medication available in both oral and topical forms, reduces androgen effects by blocking androgen receptors and, in oral form, decreasing systemic androgen activity.
Oral spironolactone is commonly prescribed for women with hair loss but requires monitoring due to its systemic hormonal effects. Topical spironolactone offers more localized androgen suppression with reduced systemic exposure.
Clascoterone, by contrast, is designed specifically for localized topical use, blocking androgen receptors at the scalp without affecting circulating hormone levels.
Clascoterone Application and Dosage Guidelines
For its FDA-approved indication, clascoterone 1% cream (Winlevi®) is applied topically to clean, dry skin twice daily, typically in the morning and evening.
Gently spread a thin layer over the affected areas of the face or trunk where acne is present. Massage the cream gently until absorbed, which usually takes about 30 seconds. Wait at least five minutes before applying other skincare products or makeup.
Hands should be washed after application, and the cream should not be applied to broken skin or used under occlusion.
Consistent daily use is essential, as clascoterone works by continuously suppressing local androgen activity within sebaceous glands rather than providing immediate results.
Proper application technique maximizes clascoterone's effectiveness while minimizing potential irritation.
Clascoterone Hair Loss Treatment Application
If approved for androgenetic alopecia, clascoterone would likely be formulated as a topical scalp solution, applied directly to areas of thinning hair.
Based on current development pathways, application would likely occur once or twice daily, with careful parting of the hair to ensure scalp contact. Regular, long-term use would be necessary to maintain androgen receptor inhibition at the follicle level.
As with other topical hair loss therapies, adherence and proper scalp application would play a critical role in treatment effectiveness.
Clascoterone Side Effects To Be Aware Of
Clascoterone is generally well tolerated, with side effects primarily limited to the application site due to its localized mechanism of action.
The most commonly reported reactions include mild redness, dryness, scaling, itching, or burning, particularly during the initial weeks of use.
These effects are often temporary and may be minimized by applying a thin, even layer to clean, dry skin and avoiding overuse. Using gentle cleansers and non-comedogenic moisturizers can also help reduce irritation.
Because clascoterone is rapidly inactivated once absorbed systemically, hormone-related side effects are uncommon. However, patients should discontinue use and consult their dermatologist if persistent irritation or unexpected reactions occur.
Clascoterone Cream: Where To Buy
Clascoterone 1% cream (Winlevi®) is prescription‑only and must be obtained through a licensed healthcare provider. It is not available over the counter. A dermatology evaluation ensures appropriate use and monitoring.
The higher‑strength clascoterone formulations, such as Breezula® for hair loss, are not yet commercially available, as they remain under clinical investigation and have not received regulatory approval.
Patients interested in clascoterone for hair regrowth should discuss current options and eligibility for clinical programs with their dermatologist.
In the meantime, there are other options to consider, such as topical prescription-strength minoxidil, finasteride, and dutasteride. Receive a dermatologist consultation with the experts at Happy Head to develop a personalized treatment plan today.
Clascoterone for Hair Growth: A Promising Future
Clascoterone has established itself as a safe and effective topical antiandrogen for acne, demonstrating the value of targeted androgen receptor inhibition.
Its extension into hair loss treatment, particularly through higher-strength formulations, represents a promising new approach for male pattern hair loss.
By acting locally at the scalp to protect follicles from DHT, clascoterone has the potential to offer a non-systemic, well-tolerated alternative to traditional oral therapies, marking an exciting advancement in dermatologic hair restoration.
For those seeking proven hair regrowth solutions available today, Happy Head offers personalized prescription formulations that provide established alternatives while investigational treatments continue through approval processes.
The key is finding the right approach for your specific needs and starting treatment early for optimal results.
Talk to a board-certified dermatologist to discuss your goals and find the solution that is best for you.
Frequently Asked Questions
Is clascoterone a topical steroid?
No. Clascoterone is not a steroid. It is a topical antiandrogen that blocks androgen receptors in the skin, reducing hormone-driven effects such as sebum production and hair follicle miniaturization, without the immune suppression or systemic risks associated with steroid creams.
What are the benefits of clascoterone?
Clascoterone reduces androgen activity locally, helping control acne and potentially protecting hair follicles from DHT-related miniaturization. Its benefits include targeted action at the skin or scalp, minimal systemic effects, and suitability for long-term use with a low risk of hormone-related side effects.
Does clascoterone cause hair growth?
Clascoterone itself is not yet approved for hair regrowth, but higher-strength formulations such as Breezula® are being developed to target androgenetic alopecia. Blocking androgen receptors in hair follicles may reduce follicle miniaturization and support regrowth, offering a promising non-systemic approach to hair loss.
How long does it take for clascoterone to work?
For acne, improvements are usually seen within several weeks of consistent twice-daily application. If approved for hair loss, hair regrowth would likely require 3–6 months of regular use, as follicles gradually recover from androgen-driven miniaturization and transition into active growth phases.
When will Breezula be available?
Breezula®, the higher-strength clascoterone solution for hair loss, is still under clinical investigation. Pending completion of required trials and regulatory submissions in the United States and Europe, it may become available following review, likely after 2026, depending on approval timelines.
