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Winlevi vs Spironolactone: How do they compare?

Medically reviewed by Kristianne Hannemann, PharmD. Last updated on July 18, 2024.

Official answer

by Drugs.com

Key Points

  • Winlevi (clascoterone) and spironolactone are both prescribed to treat acne. There are currently no head-to-head studies comparing their effectiveness.
  • Winlevi is a topical cream, while spironolactone is available in an oral tablet and oral suspension.
  • Both Winlevi and spironolactone work to treat acne by attaching to androgen receptors in the skin.
  • Spironolactone tends to have more systemic side effects, while Winlevi causes more side effects at the site of application.
  • Winlevi is a brand-name product only. Spironolactone comes in brand and generic options.

Winlevi is FDA approved to treat acne, and spironolactone is not

Winlevi (clascoterone) was approved by the FDA in 2020 to treat acne in people 12 years and older. It was studied in both males and females.

While spironolactone is not FDA approved to treat acne, it has been used off-label since the 1980s for acne treatment. It is typically used in women because it can cause undesirable side effects in men such as larger breasts.

Winlevi and spironolactone are available in different dosage forms

Winlevi is only available as a 1% topical cream. It’s applied directly to the affected areas of skin twice a day, in the morning and evening.

Spironolactone comes as a tablet and a 25 mg/5 mL oral suspension. It is prescribed off-label at doses up to 200 mg per day to treat acne.

Winlevi and spironolactone work similarly to treat acne

Both Winlevi and spironolactone work to treat acne through the same mechanism: they block androgen receptors. Winlevi works by being applied directly on the skin, while spironolactone works by being taken orally and then getting absorbed into the bloodstream.

Winlevi attaches to and blocks androgen receptors in skin cells that produce oil so a substance called dihydrotestosterone (DHT) cannot attach. This stops more of these cells from being made, and consequently skin becomes less oily. Too much oil in the skin can cause acne because it can clog pores.

Spironolactone is a potassium-sparing diuretic, but it also blocks DHT from attaching to androgen receptors in the skin cells that produce oil. This prevents acne-causing effects of DHT from occurring in the skin.

Winlevi and spironolactone have different side effects

Even though Winlevi and spironolactone have a similar mechanism of action, they have unique side effects. Winlevi is applied directly to the skin, so it mostly causes local side effects. Because spironolactone is taken orally, it causes many more systemic side effects compared to Winlevi.

Potential side effects from Winlevi include:

  • Swelling
  • Redness
  • Itching
  • Dry skin
  • Thinning of the skin
  • Stinging or burning
  • Stretch marks

Potential side effects from spironolactone include:

  • Nausea
  • Diarrhea
  • Headache
  • Low sex drive
  • Irregular menstrual period
  • Breast pain
  • Rash
  • Dizziness

These are not all possible side effects from Winlevi or spironolactone. Contact your doctor if you are experiencing bothersome side effects from either of these medications.

Related questions

Winlevi is brand only, and spironolactone has generics

If cost is an issue, you may consider that Winlevi is currently only available as a brand-name medication. Spironolactone is an older medication, and is available in both brand and generic versions. Generic medications are typically more affordable than brand-name medications, especially without insurance coverage.

Winlevi and spironolactone take about the same amount of time to work

It might take a few weeks to notice less breakouts after starting spironolactone. Similarly, you may notice improvement in your acne symptoms as early as 4 weeks after starting Winlevi. If you haven’t noticed improvement in your skin after a month of using either medication, talk to your dermatologist.

Spironolactone generally has a longer expiration date

Once you get spironolactone from the pharmacy, it is good until the expiration date set by the manufacturer. However, Winlevi must be discarded 180 days after it is dispensed, or 1 month after first opening it.

This is not all the information you need to know about Winlevi (clascoterone) or spironolactone for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

References

American Academy of Dermatology Association. (n.d.). Stubborn acne? Hormonal therapy may help. Accessed July 18, 2024 at https://www.aad.org/public/diseases/acne/derm-treat/hormonal-therapy

Anderson, L. A. (Updated July 14, 2023). How long does Winlevi take to work for acne? Accessed July 18, 2024 at https://www.drugs.com/medical-answers/how-long-winlevi-take-work-acne-3574265/

Basendwh, M. A., et. al. (2024). The efficacy of Topical Clascoterone versus systematic spironolactone for treatment of acne vulgaris: A systematic review and network meta-analysis. In: PLOS ONE. DOI: https://doi.org/10.1371%2Fjournal.pone.0298155

Layton, A. M., et al. (2017). Oral spironolactone for acne vulgaris in adult females: A hybrid systematic review. In: American Journal of Clinical Dermatology. https://doi.org/10.1007%2Fs40257-016-0245-x

Piszczatoski, C. R., et. al. (2021). Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years. In: Clinical Therapeutics. DOI: https://doi.org/10.1016/j.clinthera.2021.08.007

Spironolactone tablet [package insert]. (Updated November 20, 2020). Amneal Pharmaceuticals LLC. Accessed July 18, 2024 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb66327e-8261-46ae-b39a-4fa79d520844

Winlevi [package insert]. (Updated July 15, 2022). Sun Pharmaceutical Industries, Inc. Accessed July 18, 2024 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673a84b-7f5c-47ab-a99c-1e3db21a6a09

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