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Clascoterone (cortexolone 17α-propionate) 1% cream
A prescription topical androgen receptor inhibitor for acne — the first drug in its class, and the only antiandrogen you apply rather than swallow.
Prescription medication — not a dietary supplement
Clascoterone is a prescription (or investigational) drug, not a supplement. It is included here for reference because people research and discuss it (often used off-label) — not as a recommendation. Take it only under a qualified clinician's supervision and only as prescribed; do not source it from grey-market vendors, where identity, purity, and dosing are unverified. The evidence below reflects its clinical trials.
What the evidence says
Most Clascoterone studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from high-quality meta-analyses and randomised trials published 2011–2024 with a typical study size of 609 participants.
Based on 9 studies · 2 meta-analyses · 4 RCTs · 8,484 total participants
Confidence
High confidenceBy outcome
Two pivotal phase 3 RCTs (1440 patients), a supporting meta-analysis and FDA approval put this well above most of the corpus on evidence QUALITY. It is held at 7 rather than higher because the effect is modest and one headline outcome is null: treatment success was 19.9% vs 7.7% at 12 weeks, and the meta-analysis found no significant reduction in inflammatory lesions (MD -1.82, P = .27).
Clascoterone is a topical androgen receptor inhibitor approved by the FDA in August 2020 for acne vulgaris in patients 12 and over, sold as Winlevi.
It competes with dihydrotestosterone at the androgen receptor in sebocytes and hair follicles, and is rapidly metabolised to cortexolone in plasma, which is what keeps systemic exposure low.
That is its point of difference: spironolactone and oral antiandrogens work on the same axis but act body-wide and are effectively limited to women. Clascoterone can be used by men and women.
The trade is potency — pooled against high-dose oral spironolactone it is an order of magnitude weaker, and the meta-analysis of placebo-controlled trials found no significant effect on INFLAMMATORY lesion counts at all.
Clascoterone binds the androgen receptor in sebocytes and hair follicle cells, displacing dihydrotestosterone and reducing the androgen-driven sebum production and local inflammatory signalling that drive acne.
It is rapidly metabolised to cortexolone once it reaches the bloodstream (PMID 31251549), which is why a drug that blocks androgen receptors can be used on the face by men without the systemic antiandrogen effects that limit oral spironolactone.
Not approved below age 12. Phase 3 trials enrolled from age 9, and 2 of 27 patients aged 9 to under 12 showed abnormal cortisol stimulation tests under maximum use.
Avoid. This is an androgen receptor inhibitor and there is no adequate human pregnancy data; the phase 3 trials enrolled nonpregnant females only.
Layering with other actives increases erythema, dryness and peeling. Local skin reactions already occur in roughly 18% of users on clascoterone alone.
Clascoterone has an evidence score of 7/10 — strong evidence based on 9 indexed studies, including 2 meta-analyses. A prescription topical androgen receptor inhibitor for acne — the first drug in its class, and the only antiandrogen you apply rather than swallow. Representative study: PMID 33258536.
The commonly studied dose of Clascoterone is Apply a thin layer of clascoterone 1% cream to the affected area twice daily, morning and evening, on clean dry skin. Individual needs vary — start at the lower end of the range and adjust based on how you respond.
The best time to take Clascoterone is in split doses through the day. It can be taken on an empty stomach. Twice-daily application is the regimen used in both pivotal phase 3 trials; the once-daily regimen was only studied in the 2011 pilot.
Clascoterone is generally safe at recommended doses, with a few precautions worth noting. The most commonly reported side effects are local skin reactions (erythema, scaling/dryness, pruritus), nasopharyngitis, laboratory evidence of reversible HPA axis suppression under maximum use. Use caution if any of these apply to you: Known hypersensitivity to clascoterone or any excipient.
Adapalene
Mostly mechanism / observationalA modern topical retinoid for acne — now available over the counter (0.1%) as well as by prescription (0.3%). A drug, not a supplement or cosmetic. Adapalene is a third-generation retinoid selective for the retinoic-acid receptor beta; it normalizes how skin cells shed (comedolytic) and is anti-inflammatory. The honest framing: this is one of the best-evidenced acne treatments — a 5-trial meta-analysis and a 40-trial network meta-analysis show it matches tretinoin's efficacy with faster onset and notably better tolerability, and the adapalene-benzoyl peroxide combination is among the most effective regimens available. Caveats: it still causes retinoid irritation and slow onset, it is not superior to (only as good as) other retinoids, and — as a retinoid — it is generally avoided in pregnancy.
Benzoyl Peroxide
Mostly mechanism / observationalA frontline over-the-counter acne medicine applied to the skin — a drug, not a supplement or cosmetic. Benzoyl peroxide (BPO) kills the acne bacterium Cutibacterium (Propionibacterium) acnes by an oxidative mechanism that, crucially, does NOT drive antibiotic resistance, and it is also mildly comedolytic and anti-inflammatory. The honest framing: this is one of the best-evidenced topical acne treatments — a 120-trial Cochrane review and a 35-RCT network meta-analysis show it beats placebo and matches topical antibiotics — but it commonly causes dryness and irritation, it bleaches fabrics, towels, and hair, and BPO monotherapy is consistently outperformed by fixed combinations (adapalene-BPO, clindamycin-BPO). A genuinely effective acne drug with real, manageable downsides.
Tretinoin (Retin-A)
Mostly mechanism / observationalA prescription TOPICAL retinoid (Retin-A, Renova) — the acid form of vitamin A and the gold-standard, best-evidenced topical treatment for photoaging and acne. Multiple double-blind RCTs show it reduces fine wrinkles, mottled hyperpigmentation, and roughness over months, with histologic increases in dermal collagen. Caveats: retinoid dermatitis (irritation, peeling, dryness), photosensitivity, and it is CONTRAINDICATED IN PREGNANCY. Prescription drug, not a supplement; distinct from weaker OTC 'retinol' cosmetics.
Azelaic Acid
Mostly mechanism / observationalA topical skincare acid applied to the skin for rosacea, acne, and uneven tone — unusual among 'cosmetic' actives because it has genuine drug-grade evidence. Azelaic acid is a naturally occurring dicarboxylic acid that is anti-inflammatory, antimicrobial, and a tyrosinase inhibitor. It is sold both as an over-the-counter cosmetic (around 10%) AND as a 15-20% prescription medication. The honest framing: the strongest, best-replicated evidence — including double-blind phase III trials and a Cochrane review that rated it high-quality for papulopustular rosacea — used the PRESCRIPTION strengths (15-20%), not the ~10% OTC cosmetic form. It also has solid evidence for acne and melasma. Head-to-head it is beaten for acne (by benzoyl peroxide + clindamycin) and tends to cause more local irritation (burning, stinging) than several comparators. For rosacea or persistent acne, the prescription form under a clinician is the evidence-based route.
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Reviewed by Dr. Baher Al Hakim · Last reviewed September 2026 · evidence from 9 studies · how we score · editorial policy
This information is for educational purposes only. It is not a substitute for professional medical advice. Always consult a qualified healthcare provider before starting, stopping, or changing any supplement or medication.