# How Clascoterone Works for Hormonal Acne
Hormonal acne happens when androgens, which are male hormones present in both men and women, trigger oil glands in the skin to produce excess sebum. This excess oil clogs pores and creates an environment where acne-causing bacteria thrive. For decades, treating this type of acne meant either using oral medications that affect the entire body’s hormone system or relying on topical treatments that don’t address the root hormonal cause. Clascoterone represents a new approach that targets the problem directly at the skin level.
Clascoterone is a topical antiandrogen that was approved by the FDA in 2020 under the brand name Winlevi for treating acne in patients aged 12 and older. Unlike older hormonal acne treatments, clascoterone works locally on the skin without significantly entering the bloodstream. This means it can address hormonal acne without the systemic side effects associated with oral anti-androgen medications.
The way clascoterone works is straightforward. The hormone DHT, which is derived from testosterone, binds to androgen receptors in skin cells and hair follicles. This binding triggers sebocytes, which are oil-producing cells, to make more sebum. Clascoterone competitively blocks DHT from attaching to these androgen receptors. By preventing DHT from binding, clascoterone reduces sebum production and decreases the inflammatory cascade that leads to acne formation. Essentially, it stops the hormonal signal that tells skin cells to produce excess oil.
Clinical trials demonstrated that clascoterone is effective. In a study pooling data from two Phase III trials involving 1,421 patients who used clascoterone 1% cream twice daily for 12 weeks, 19.9% of patients achieved treatment success compared to only 7.7% in the control group. Treatment success was defined as achieving clear or nearly clear skin with at least a two-point improvement. Patients saw clinical improvement as early as week two of treatment. The medication reduced both inflammatory acne lesions, which are the red bumps and pustules, and non-inflammatory lesions, which are blackheads and whiteheads. In longer-term studies extending up to nine months, 49% of patients with facial acne and 52% with truncal acne achieved clear or nearly clear skin by the end of the study.
One major advantage of clascoterone is its safety profile. Because it acts only on the skin and is rapidly metabolized, systemic absorption is minimal. This means it does not significantly suppress hormones throughout the body. Clinical data from acne trials showed no meaningful suppression of systemic hormone markers even after weeks of application. Patients using clascoterone experienced only mild, local adverse events. Unlike retinoids and benzoyl peroxide, which commonly cause peeling, dryness, redness, and irritation, clascoterone showed no recorded occurrences of these side effects in clinical investigations. Patient-reported stinging, burning, and itching were either absent or minimal.
This excellent tolerability is particularly important because it means patients can actually stick with the treatment. Many acne medications require patients to sacrifice comfort for effectiveness, leading people to stop using them. Clascoterone’s gentle profile encourages compliance with the twice-daily application regimen needed for best results.
Another benefit is that clascoterone works for both men and women. Oral anti-androgen medications like spironolactone are typically prescribed only to women because they can cause feminizing side effects in men. Since clascoterone acts locally without systemic hormonal effects, it is suitable for male patients who have hormonal acne but cannot tolerate or do not want systemic hormonal therapy.
The mechanism of clascoterone also addresses a fundamental cause of hormonal acne rather than just treating symptoms. While antibiotics kill acne bacteria and retinoids help skin cells shed normally, clascoterone reduces the excess sebum production that initiates the acne process in the first place. By reducing sebum, it addresses what dermatologists consider the core problem in hormonal acne.
Clascoterone represents an important advance because it offers a new way to treat hormonal acne that is both effective and well-tolerated. It provides patients with a topical option that works through a different mechanism than existing treatments, making it useful for people who have not responded to other therapies or who want to avoid the systemic effects of oral hormonal medications.
Sources
https://pmc.ncbi.nlm.nih.gov/articles/PMC12691598/
https://www.ajmc.com/view/the-tolerable-future-of-acne-treatment-reducing-sebum
