Topical androgen receptor inhibitor Pregnancy: US label §8.1: there are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous clascoterone given to pregnant rats and rabbits during organogenesis at doses 8 or 39 times the maximum recommended human dose respectively increased malformations in rats and post-implantation loss and resorptions in rabbits. (US risk-summary format; no UK SPC §4.6 was retrieved.)

Clascoterone

Brand names: Winlevi

Clascoterone is a topical androgen receptor inhibitor applied to the skin for the treatment of acne vulgaris.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Apply a thin uniform layer (approximately 1 gram) of clascoterone 1% cream to the affected area twice per day, in the morning and the evening

Route: Topical — for topical use only. Not for ophthalmic, oral or vaginal use.

Frequency: Twice daily (morning and evening)

PROVENANCE: no UK SPC (eMC) record was retrieved in this bundle — the regimen above is taken from the US FDA prescribing information for WINLEVI (clascoterone) cream 1% (Sun Pharmaceutical Industries, label date 2025-01-02). Verify against the UK SPC before use. Method: cleanse the affected area gently; after the skin is dry, apply the cream to the affected area. Avoid accidental transfer into eyes, mouth or other mucous membranes; if contact with mucous membranes occurs, rinse thoroughly with water. STRENGTH: cream 1% — each gram contains 10 mg of clascoterone. No maximum dose or maximum treatment duration is stated in the retrieved sections. PAEDIATRIC (§8.4): safety and effectiveness for topical treatment of acne vulgaris 'have been established in 641 pediatric patients, aged 12 to 18 years' in two vehicle-controlled 12-week trials; safety and effectiveness 'has not been established in pediatric patients under 12 years of age'. No separate paediatric regimen or per-kg dose is given — patients aged 12 and over use the adult application above. HPA axis suppression was observed in 2/22 (9%) adolescent subjects, all of whom returned to normal HPA axis function 4 weeks after stopping treatment; children may be more susceptible to systemic toxicity. Verify paediatric use against a children's formulary. ELDERLY (§8.5): studies did not include sufficient subjects aged 65 and over; in general dose selection for an elderly patient should be cautious. §5, §8.1 and §6 are marked truncated at the source-fetch limit; §7 (drug interactions) was not included in this bundle.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

None (US label §4 states 'None')

Side effects

Erythema/reddening (7 to 12% of patients)
Pruritus (7 to 12% of patients)
Scaling/dryness (7 to 12% of patients)
Oedema, stinging and burning (occurred in more than 3% of patients, and were reported in a similar percentage of subjects treated with vehicle)
From §5 Warnings: local irritation (may require reducing the frequency of application or discontinuing); hypothalamic-pituitary-adrenal (HPA) axis suppression during or after treatment; hyperkalaemia — elevated potassium levels were observed in some subjects during the clinical trials

Clinical monograph

How it works

It competes with androgens such as dihydrotestosterone for binding to androgen receptors in the sebaceous gland and hair follicle, reducing sebum production and the inflammation that contribute to acne.

Prescribing in practice

Local skin reactions and signs suggestive of hypothalamic-pituitary-adrenal axis suppression have been reported, particularly with extensive or prolonged use, so apply only to affected areas as directed.
It is for topical use only and should not be applied to the eyes, mouth or other mucous membranes.
Apply to clean, dry skin and avoid use on cut, broken or eczematous skin.

Monitoring

Monitor clinically for treatment response and local irritation; consider HPA-axis effects if used over large areas for prolonged periods.

Counselling the patient

Apply a thin layer to the affected areas of the face as directed.
Some local dryness, redness or scaling can occur.
Use only on the skin and keep it away from the eyes and mouth.

Evidence & guidelines

Clascoterone is a topical anti-androgen licensed for the treatment of acne vulgaris on the basis of its clinical trial programme.

Reference: Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways