What is Winlevi?: A Deep Dive into the First-in-Class Acne Medication

October 7, 2025 •

4 min read

Acne vulgaris affects up to 50 million people in the United States annually [1.2.4]. A novel treatment option, this article explains what is Winlevi? (clascoterone cream 1%), a prescription medication that targets the hormones in the skin that contribute to acne [1.2.1, 1.3.4].

Quick Summary

Winlevi (clascoterone) is a prescription topical cream approved to treat acne vulgaris in patients 12 and older [1.2.1]. It is a first-in-class androgen receptor inhibitor that targets oil production and inflammation at the source [1.3.4, 1.2.2].

Key Points

First-in-Class Mechanism: Winlevi is the first FDA-approved topical androgen receptor inhibitor for treating acne, offering a novel mechanism of action [1.3.4].
Targets Hormones in the Skin: It works by directly blocking the effects of acne-causing hormones (androgens) in the sebaceous glands to reduce oil (sebum) production [1.3.3, 1.3.5].
Broad Patient Approval: It is approved for treating acne vulgaris in both males and females aged 12 years and older [1.2.1, 1.4.3].
Non-Antibiotic Treatment: Winlevi provides an effective non-antibiotic option, which is beneficial in addressing concerns about antibiotic resistance [1.3.4].
Proven Efficacy: Clinical trials demonstrated a significant reduction in both inflammatory and non-inflammatory acne lesions after 12 weeks of twice-daily use [1.5.3].
Topical vs. Systemic: Unlike oral medications like spironolactone, Winlevi acts locally on the skin, minimizing the risk of systemic side effects [1.2.2].
Common Side Effects: The most frequently reported side effects are mild-to-moderate local skin reactions, such as redness, itching, and dryness [1.5.3].

Understanding Acne and Hormones

Acne is a common skin condition driven by multiple factors, but hormones called androgens play a crucial role [1.2.1]. Androgens stimulate sebaceous glands in the skin to produce an oily substance called sebum. Excess sebum can clog pores, creating an environment where acne-causing bacteria thrive, leading to inflammation and breakouts [1.8.3]. This hormonal component is why acne can be persistent and affect both males and females throughout different life stages, including puberty and adulthood [1.2.1]. For years, treatments targeting this pathway were limited to oral medications, which have systemic effects [1.2.4].

What is Winlevi (Clascoterone)?

Winlevi, with the generic name clascoterone, is a prescription topical cream (1%) that was FDA-approved in August 2020 for the treatment of acne vulgaris in patients aged 12 years and older [1.4.1, 1.4.3]. What makes it a noteworthy development is its unique mechanism of action; it is the first topical androgen receptor inhibitor approved for this use [1.3.4, 1.3.5]. This allows it to directly address the hormonal component of acne on the skin, offering a targeted approach without the systemic exposure of oral medications like spironolactone [1.2.2, 1.2.4].

How Does Winlevi Work? The Mechanism of Action

While the precise mechanism is still being fully understood, laboratory studies suggest that Winlevi's active ingredient, clascoterone, works by competing with androgens, specifically dihydrotestosterone (DHT), for binding to androgen receptors within the skin's sebaceous glands and hair follicles [1.3.3, 1.3.5]. By blocking these receptors, clascoterone is believed to inhibit the downstream signaling that leads to increased sebum production and inflammation [1.3.5, 1.3.7]. This targeted action helps reduce the oil that clogs pores and lessens the inflammation associated with acne breakouts, making it an effective option for both inflammatory (papules, pustules) and non-inflammatory (comedones) lesions [1.5.3, 1.2.4].

Who Can Use Winlevi?

Winlevi is FDA-approved for both males and females aged 12 and older who are experiencing acne vulgaris [1.2.1, 1.4.3]. This makes it a significant option, especially for males and for females who either do not want to or cannot take oral hormonal therapies like birth control or spironolactone [1.2.4]. Clinical trials demonstrated its efficacy and safety in this broad patient population with moderate to severe acne [1.5.3].

How to Use Winlevi Cream

Proper application is key to achieving the best results with Winlevi. It should be used exactly as prescribed by a healthcare provider.

Cleanse and Dry: Gently wash and pat dry the affected skin area [1.7.1].
Apply a Thin Layer: Squeeze out approximately a pea-sized or fingertip amount (about 1 gram) of the cream and apply a thin, even layer to the entire affected area [1.7.3, 1.7.2]. Winlevi is not intended as a spot treatment [1.8.5].
Twice Daily: This routine should be performed twice a day, typically once in the morning and once in the evening [1.7.1].
Wash Hands: After application, wash your hands to avoid accidental transfer to the eyes, mouth, or other mucous membranes [1.7.1]. If contact occurs, rinse the area thoroughly with water [1.7.2].

It is also advised to avoid using Winlevi on cut, abraded, or sunburned skin and to limit the use of other potentially irritating topical products [1.8.2].

Potential Side Effects and Safety

The most common side effects associated with Winlevi are local skin reactions, which are generally mild to moderate [1.8.4]. These include:

Erythema (redness) [1.5.3]
Pruritus (itching) [1.5.3]
Scaling or dryness [1.5.3]
Stinging or burning [1.5.3]

In clinical trials, these reactions occurred in 7% to 12% of patients but were reported at a similar rate in patients using the vehicle cream without the active ingredient [1.8.1, 1.5.3]. A rare but more serious potential side effect is hypothalamic-pituitary-adrenal (HPA) axis suppression, where the adrenal gland may not produce enough of certain hormones [1.5.1]. The risk is low with prescribed use but increases with application over large surface areas or for prolonged periods [1.5.1].

Winlevi vs. Other Acne Treatments

Winlevi offers a unique approach compared to other common acne therapies.


Feature	Winlevi (Clascoterone)	Spironolactone (Oral)	Tretinoin (Topical)
Mechanism of Action	Topical androgen receptor inhibitor; reduces sebum and inflammation locally [1.3.7, 1.6.3].	Oral androgen receptor blocker; systemically reduces androgen effects on skin [1.6.1].	A retinoid (Vitamin A derivative); increases skin cell turnover to unclog pores [1.6.2].
Application	Topical cream applied twice daily to affected areas [1.7.4].	Oral tablet taken daily [1.6.1].	Topical cream or gel, usually applied once daily at bedtime [1.6.2].
Use in Males	Yes, FDA-approved for males and females [1.2.4].	No, typically not used in males for acne due to systemic side effects [1.2.3].	Yes, used by both males and females.
Key Side Effects	Local skin irritation (redness, dryness, itching) [1.5.3].	Systemic effects (irregular periods, breast tenderness, dizziness, high potassium) [1.2.3].	Skin irritation (peeling, redness, dryness), sun sensitivity [1.6.2].

What Results to Expect

Clinical studies have shown that patients using Winlevi can see a noticeable reduction in both inflammatory and non-inflammatory acne lesions [1.5.3]. Significant improvement is typically seen after 12 weeks of consistent, twice-daily use [1.7.1, 1.5.3]. Some patients may begin to see improvements as early as 4 weeks [1.2.3].

Conclusion

Winlevi (clascoterone cream 1%) represents a significant advancement in dermatology as the first topical androgen receptor inhibitor for treating acne vulgaris. By directly targeting the hormonal drivers of acne in the skin, it effectively reduces sebum production and inflammation without the need for systemic treatment [1.3.4, 1.3.5]. Its approval for both males and females 12 and older provides a valuable non-antibiotic option for a wide range of patients struggling with hormonal acne [1.2.4]. As with any prescription medication, it is essential to consult with a dermatologist to determine if Winlevi is the right choice for your acne treatment plan.

For more information directly from the manufacturer, visit the official WINLEVI® website.

Frequently Asked Questions

No, Winlevi is neither a steroid nor a retinoid. It is a first-in-class topical androgen receptor inhibitor, a type of hormonal medication that works differently from other acne treatments [1.2.7].

Yes, Winlevi is FDA-approved for use in both men and women aged 12 and older. Because it is a topical treatment, it does not cause the systemic hormonal side effects that prevent the use of oral anti-androgens like spironolactone in men [1.2.2, 1.2.4].

Significant results are typically seen after 12 weeks of consistent use. Some patients may notice improvements in their acne as early as four weeks [1.7.1, 1.2.3].

Yes, Winlevi (clascoterone) cream 1% is a prescription medicine and is not available over-the-counter [1.2.1].

Winlevi is a topical cream that works directly on the skin to block androgen receptors. Spironolactone is an oral medication that blocks androgen receptors systemically (throughout the body). Because of this, spironolactone has more systemic side effects and is generally only used by women for acne [1.2.3, 1.6.1].

It is possible to use Winlevi in combination with other acne treatments, such as tretinoin. However, since both can cause skin irritation, you should consult your dermatologist for guidance on how to incorporate them into your routine safely [1.2.5, 1.6.6].

The most common side effects are local skin reactions at the application site, including redness, scaling or dryness, and itching. These are typically mild to moderate [1.5.3, 1.2.1].