# A-08 — Clascoterone

The topical anti-androgen — the same target as oral spironolactone, acting where the acne is. Irritation no worse than its own vehicle.

- **Canonical:** https://www.30plusskin.care/actives/clascoterone
- **Site:** 30+/SKIN — Skincare, published as a spec sheet.
- **Issue:** ISSUE NO. 13 / REV. 2026.10
- **Standing terms:** INDEPENDENT · AFFILIATE-FUNDED · NOT MEDICAL ADVICE

---

## Datasheet

- **INN / INCI:** Clascoterone
- **Family:** Androgen receptor inhibitor — first topical
- **Molecular weight:** 402.5 g/mol
- **Layer reached:** EPIDERMIS
- **Prescription only:** yes
- **Evidence grade:** A
- **Controlled trials on file:** 2
- **Strength range recorded:** 1%–1%
- **Representative reference concentration:** 1%
- **Irritation (0–10):** 1
- **Onset:** 12 WK
- **Stability:** REFRIGERATE BEFORE DISPENSING · DISCARD 1 MONTH AFTER OPENING

## Mechanism

The concentration marker is not a recommended dose or a claim that other strengths are untested. Compare the vehicle, indication and trial population.

Competes with dihydrotestosterone at the androgen receptor in the sebaceous gland and hair follicle. The label states that the mechanism of action for acne itself is unknown.

## Measured endpoints

| Endpoint | Effect vs comparator | Window | Record |
| --- | --- | --- | --- |
| IGA success, acne | +14.3% | 12 WK | REF-16 — Winlevi — trial 2 (NCT02608476), acne vulgaris (Multicentre randomised, vehicle-controlled; treatment difference 14.3% (95% CI 8.9–19.7), n=729, grade A) |
| HPA axis suppression at day 14 | 0% | 2 WK | REF-17 — Winlevi — HPA axis assessment in the pharmacokinetic study (Open-label pharmacokinetic study, twice-daily application, adults and adolescents, n=42, grade B) |

## Layering

- **Do not layer with:** Cuts, abrasions, eczematous or sunburned skin
- **Pairs with:** Retinoids, Benzoyl peroxide

## Notes

- Across eight measured local reaction types, none was meaningfully worse than vehicle — erythema and skin atrophy were both lower on drug than on the cream base.
- Topical does not mean local. HPA axis suppression appeared in 5% of adults and 9% of adolescents after fourteen days, reversing within four weeks of stopping.
- Trialled at a mean age of 19.7 and marketed for adult hormonal acne. The receptor is the same receptor; the evidence for that use is extrapolation.
- A 60 g tube must be discarded one month after opening, which for most users means binning a substantial share of an expensive tube on the label's own instruction.

## Products in the register containing it

| No. | Product | Stance | Score | Document |
| --- | --- | --- | --- | --- |
| R-39 | Sun Pharmaceutical Winlevi | CONDITIONAL | 72/100 | /reviews/winlevi-clascoterone-cream-review |

---

## PROMOTIONAL SPOTLIGHT: Explore CoreAge Rx skincare

More options for your skin. A patient community to connect with along the way.

**Five skincare options to explore** — Browse CoreAge Rx's prescription skincare range for concerns including fine lines, dark spots, blemishes and more.

**Connect with other patients** — Explore the CoreAge Rx patient community for shared experiences, conversations and support beyond your daily routine.

[CHECK OUT COREAGE RX SKINCARE](https://try.coreagerx.com/skincare?utm_source=30plusskin.care&utm_medium=affiliate&utm_campaign=skincare_reviews&utm_content=reading_footer)

[EXPLORE THE PATIENT COMMUNITY](https://community.coreagerx.com/)

[Read our CoreAge Rx reviews](/reviews/coreage-rx-skincare-review)

Prescription options require a clinician's assessment. Compounded medications are not FDA-approved. Community discussions do not replace medical advice.

[Product range](https://help.coreagerx.com/medication/coreage-rx-prescription-skincare) · [Community information](https://www.coreagerx.com/contact-us/)

[About promotional placements](/disclosure)

---

## Elsewhere in the register

- [Review register](/reviews)
- [Active monographs](/actives)
- [Brand register](/brands)
- [Evidence register](/evidence)
- [The ledger](/ledger)
- [How we test](/how-we-test)
- [Agent guide](/llms.txt)
- [Sitemap](/sitemap.xml)

_SOURCE-BASED ASSESSMENTS. PUBLISHER PREFERENCES ARE IDENTIFIED SEPARATELY._