Clascoterone 1% Cream for Hormonal Acne

Acne is not simply a surface problem. It develops from a combination of excess oil production, clogged pores, bacterial overgrowth and inflammation. For many patients, particularly those with persistent jawline, chin, chest or back breakouts, hormones play a central role in driving this process.

Androgens, such as dihydrotestosterone (DHT), stimulate the sebaceous glands to produce more oil. When oil production increases, pores become more easily blocked, creating an environment where acne lesions can form and persist. This is why some patients continue to experience breakouts despite using conventional treatments like retinoids or benzoyl peroxide.

Clascoterone 1% cream (brand name Winlevi) offers a different approach. It is the first topical medication designed to directly block androgen receptors within the skin. Instead of altering hormone levels throughout the body, it works locally at the level of the oil gland to reduce hormonal stimulation where acne begins [1].

As a prescription treatment, clascoterone provides a targeted option for patients seeking a non-antibiotic, non-systemic solution for hormonally driven acne. It can be used in both males and females aged 12 years and older and may be considered as part of a personalised acne treatment plan following medical assessment.

Why Hormones Matter in Acne Development

Acne develops through several interconnected processes within the skin. While bacteria and inflammation are often blamed, hormonal stimulation is one of the key drivers behind persistent or recurrent breakouts.

There are four main factors involved in acne formation:

• Increased sebum production — Androgens stimulate the sebaceous (oil) glands. When these hormones signal the glands to produce excess oil, the skin becomes more prone to congestion [2]. This oily environment also supports bacterial growth.
• Follicular hyperkeratinisation — Skin cells lining the hair follicles do not shed normally. Instead, they accumulate and mix with sebum, forming plugs that block pores [3]. These blocked pores develop into blackheads and whiteheads.
• Cutibacterium acnes proliferation — This naturally occurring skin bacterium thrives in oil-rich, oxygen-poor environments. When pores are blocked, bacterial overgrowth can trigger immune activation [4].
• Inflammation — The body’s immune response to blocked follicles and bacterial byproducts leads to redness, swelling, and the formation of papules, pustules, nodules or cysts.

While many traditional treatments target bacteria, inflammation or abnormal cell turnover, hormonal stimulation of the oil gland often remains an underlying trigger. For patients whose acne flares around hormonal cycles, persists into adulthood or concentrates along the lower face and jawline, androgen activity within the skin can play a particularly significant role. Targeting this hormonal pathway directly offers a more focused way to manage acne at its source.

What is Winlevi (Clascoterone 1% Cream)?

Winlevi® is the brand name for clascoterone 1% cream, a prescription topical medication used to treat acne vulgaris. It is the first topical androgen receptor inhibitor approved specifically for acne, offering a targeted way to address the hormonal component of breakouts directly within the skin [5].

Clascoterone is a synthetic steroid molecule designed to act locally at the level of the sebaceous gland. When applied to the skin, it competes with natural androgens, such as dihydrotestosterone (DHT), for binding to androgen receptors in sebocytes. By blocking these receptors, clascoterone reduces the hormonal signals that stimulate excess oil production and contribute to inflammation.

Unlike oral anti-androgen medications, which affect hormone activity throughout the body, clascoterone works primarily where it is applied. It is rapidly metabolised within the skin, which limits systemic absorption and reduces the risk of widespread hormonal effects. This localised mechanism makes it suitable for both males and females and provides an alternative for patients who may not be candidates for systemic therapy.

As part of a medically supervised acne treatment plan, clascoterone can be used alone or in combination with other topical agents to address the different pathways involved in acne development [6].

How Does Clascoterone Work?

Clascoterone targets one of the key drivers of acne: hormonal stimulation of the oil glands. Instead of affecting hormone levels throughout the body, it works directly within the skin where acne begins.

When applied to acne-prone areas, clascoterone:

• Blocks DHT at the receptor level — It competes with dihydrotestosterone (DHT), preventing it from binding to androgen receptors in the sebaceous glands.
• Reduces excess oil production — By limiting hormonal stimulation, it helps decrease sebum output, making pores less prone to congestion.
• Helps calm inflammation — Lower androgen signalling reduces inflammatory activity associated with acne lesions.
• Works locally, not systemically — It acts primarily within the skin and does not lower overall testosterone levels or disrupt systemic hormonal balance.

With consistent twice-daily use, this targeted mechanism helps reduce the formation of new breakouts while supporting clearer, more stable skin over time.

Clinical Evidence and Effectiveness of Clascoterone 1% Cream 

Clascoterone 1% cream has been evaluated in large, randomised, double-blind, vehicle-controlled Phase 3 clinical trials involving patients aged 9 years and older with moderate to severe acne [7]. These studies provide strong evidence supporting its effectiveness and safety as a topical treatment.

Key findings from these trials showed:

• Significant reduction in inflammatory lesions —  Patients using clascoterone experienced meaningful decreases in papules and pustules compared to those using vehicle cream.
• Reduction in non-inflammatory lesions —  Improvements were also seen in comedones (blackheads and whiteheads), reflecting its impact on oil-driven congestion.
• Higher treatment success rates —  A greater proportion of patients achieved clear or almost clear skin based on Investigator’s Global Assessment (IGA) scoring, with at least a two-grade improvement from baseline.
• Progressive improvement over 12 weeks —  Clinical benefits were typically observed within the first few weeks, with continued improvement throughout the 12-week treatment period.

These results demonstrate that targeting androgen receptors directly within the skin can lead to measurable reductions in both active breakouts and overall acne severity. When used consistently as prescribed, clascoterone provides a clinically validated, hormone-targeted option for acne management.

Who is Suitable for Clascoterone?

Clascoterone 1% cream may be considered for patients whose acne is driven, at least in part, by hormonal stimulation of the oil glands. It is approved for individuals aged 12 years and older and can be used in both males and females.

This treatment may be suitable for:

• Hormonal-pattern acne — Breakouts concentrated along the jawline, chin, lower cheeks, chest or back, especially if flares are cyclical or persistent.
• Oily skin with recurrent congestion — Patients whose acne is strongly linked to excess sebum production.
• Adolescent and adult acne — Including individuals who continue to experience acne beyond their teenage years.
• Male patients with hormonal acne — Unlike oral anti-androgen medications, which are generally unsuitable for men due to systemic effects, clascoterone works locally in the skin without lowering testosterone levels.
• Patients seeking non-antibiotic options — Particularly those wishing to avoid long-term antibiotic use.
• Those who are not candidates for systemic therapy — Including individuals who prefer to avoid oral medications or who have experienced side effects from systemic treatments.

Clascoterone can be used as a standalone therapy or incorporated into a broader acne treatment plan following medical assessment. Suitability is best determined during consultation, where skin type, acne severity, previous treatments and overall health are carefully evaluated.

Clascoterone for Men with Hormonal Acne

Hormonal acne is often discussed in the context of female patients, yet androgens play a significant role in acne development in men as well. In fact, men typically have higher levels of dihydrotestosterone (DHT), the hormone most strongly linked to increased oil production.

Until recently, treatment options that specifically targeted hormonal pathways were largely systemic and not suitable for male patients due to the risk of broader hormonal effects. Clascoterone offers a different approach. As a topical androgen receptor inhibitor, it works directly within the skin to block DHT at the level of the sebaceous gland.

For men experiencing persistent breakouts along the jawline, beard area, chest or back,  particularly when associated with oily skin, this targeted mechanism can be especially relevant. Because clascoterone acts locally and is rapidly metabolised in the skin, it does not reduce circulating testosterone levels or affect libido.

For male patients who have not achieved adequate control with standard topical treatments such as benzoyl peroxide or retinoids, clascoterone provides a focused, hormone-directed option without the systemic risks associated with oral anti-androgen medications.

How is Clascoterone Used?

Clascoterone 1% cream is typically applied twice daily, once in the morning and once in the evening, to clean, dry skin. It is prescribed for use on acne-affected areas of the face and, where appropriate, the chest or back.

For best results:

• Apply a thin layer to the entire acne-prone area — Clascoterone works preventatively by reducing oil gland stimulation. It should be applied to the full affected zone, not just individual pimples.
• Use the correct amount — A pea-sized amount is generally sufficient for the entire face. Using more does not improve results and may increase irritation.
• Be consistent — Acne treatments require regular use. Clinical improvement typically develops gradually over several weeks.
• Incorporate into a structured routine — Clascoterone can be used alone or alongside other treatments such as retinoids or benzoyl peroxide, depending on your personalised plan.
• For men who shave — Apply after shaving and rinsing, once the skin is dry. It may be layered before moisturiser or aftershave products if tolerated.

Mild dryness, redness or irritation may occur during the initial weeks. These reactions are usually temporary and can be managed with appropriate skincare adjustments as guided during consultation.

Safety and Side Effects of Clascoterone Acne Cream 

Clascoterone 1% cream has demonstrated a favourable safety profile in large clinical trials involving patients with moderate to severe acne [8]. Because it works locally within the skin and is rapidly metabolised, systemic hormonal effects have not been observed in studies.

The most commonly reported side effects are mild and limited to the application site. These may include:

• Redness (erythema)
• Dryness
• Itching (pruritus)
• Mild scaling or flaking

These reactions are generally temporary and tend to improve as the skin adjusts to treatment. Discontinuation due to side effects is uncommon.

As with any prescription medication, suitability should be assessed during consultation. Patients who are pregnant, planning pregnancy or breastfeeding should discuss risks and benefits with their doctor before starting treatment.

Clascoterone vs. Spironolactone vs. Retinoids

Different acne treatments target different pathways. Understanding how they compare can help determine which option is most appropriate for your skin.

Feature	Clascoterone 1% Cream	Oral Spironolactone	Topical Retinoids (e.g. Tretinoin)
Drug Class	Topical androgen receptor inhibitor	Oral anti-androgen / diuretic	Vitamin A derivative
Primary Action	Blocks DHT at oil gland receptors	Reduces androgen activity systemically	Increases cell turnover and unclogs pores
Best For	Hormonal acne in males & females	Hormonal acne in adult females	Comedonal and inflammatory acne
Route of Use	Topical (cream)	Oral (tablet)	Topical (cream/gel)
Approval Status	FDA-approved for acne	Used off-label for acne	FDA-approved for acne
Common Side Effects	Local redness, dryness, itching	Menstrual changes, breast tenderness, dizziness	Peeling, irritation, sun sensitivity
Gender Suitability	Suitable for males & females (12+)	Typically prescribed to females	Suitable for males & females
Lab Monitoring	Not required	May require potassium/kidney monitoring	Not required
Time to Visible Results	~12 weeks	3–6 months	8–12 weeks

Clascoterone differs in that it targets the hormonal pathway directly within the skin, without altering hormone levels throughout the body. This makes it a potential option for both male and female patients seeking a topical, hormone-directed approach to acne management.

Summary 

Clascoterone 1% cream represents a targeted, hormone-directed option for managing acne vulgaris. By blocking androgen receptors directly within the skin, it addresses one of the key drivers of excess oil production without altering systemic hormone levels. Clinical studies have demonstrated meaningful reductions in both inflammatory and non-inflammatory lesions, with a favourable safety profile and suitability for both male and female patients aged 12 years and older.

As part of a personalised treatment plan, clascoterone may be used alone or combined with other therapies to address multiple pathways involved in acne development. Careful assessment of skin type, acne severity, previous treatments and lifestyle factors is essential to determine whether this option is appropriate.

If you are experiencing persistent hormonal acne or have not achieved satisfactory results with conventional treatments, schedule a consultation with Apax Medical & Aesthetic Clinic for a comprehensive skin assessment and a tailored treatment plan designed to support clearer, healthier skin.

Frequently Asked Questions (FAQs) 

References 

1. Peterson, H., Kircik, L., & Armstrong, A. W. (2023). Individual article: Clascoterone cream 1%: mechanism of action, efficacy, and safety of a novel, first-in-class topical antiandrogen therapy for acne. Journal of Drugs in Dermatology: JDD, 22(6), SF350992s7-SF350992s14. https://pubmed.ncbi.nlm.nih.gov/37276168/ 
2. Makrantonaki, E., Ganceviciene, R., & Zouboulis, C. (2011). An update on the role of the sebaceous gland in the pathogenesis of acne. Dermato-Endocrinology, 3(1), 41–49. https://doi.org/10.4161/derm.3.1.13900 
3. Thiboutot, D. M. (2000). The role of follicular hyperkeratinization in acne. Journal of Dermatological Treatment, 11(2), 5–8. https://doi.org/10.1080/095466300750163645 
4. Mayslich, C., Grange, P. A., & Dupin, N. (2021). Cutibacterium acnes as an opportunistic pathogen: An update of its virulence-associated factors. Microorganisms, 9(2), 303. https://doi.org/10.3390/microorganisms9020303 
5. Balado-Simó, P., Brufau-Cochs, M., & Morgado-Carrasco, D. (2026). Clascoterone 1% in the treatment of acne: A review of its efficacy, safety, and therapeutic positioning. Actas Dermo-Sifiliográficas, 117(4), 104587. https://doi.org/10.1016/j.ad.2025.104587 
6. Draelos, Z. D., Draelos, M. M., Kyeremateng, K., & Squittieri, N. (2025). Clascoterone stability when combined with topical acne medications in vitro. Dermatology and Therapy, 15(12), 3605–3613. https://doi.org/10.1007/s13555-025-01553-5 
7. 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  
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. JAMA Dermatology, 156(6), 1–10. https://doi.org/10.1001/jamadermatol.2020.0465