Skincare and Technology

Winlevi® (clascoterone cream 1%): A new FDA-approved drug for hormonal acne

WINLEVI cream is a new topical acne treatment by the Italian biotech Cassiopea which has been approved by the FDA recently. WINLEVI is the first acne drug with a new mechanism of action in 38 years; the last one was Accutane!

How does this new drug work to combat acne?

Acne is a multifactorial skin condition, affected by 3 distinct pathways: excess oil production, C. acne bacteria, and inflammation.

Products such as benzoyl peroxide and topical antibiotics can target the acne bacteria and ingredients such as retinoids and salicylic acid can help regulate sebum production and avoid clogged pores, the inflammation which is caused by excess androgen is usually addressed via oral medications.

To treat hormonal acne breakouts and reduce androgen activity usually birth control and spironolactone pills, which are are associated with systemic adverse effects, are prescribed. WINLEVI contains a new active called Clascoterone. This active has the ability to inhibit androgen receptor topically. Androgens in your skin are responsible for the production of oil and can lead to inflammation, which exacerbates acne, by locally blocking androgens, Winlevi prevents the production of excess oil and decreases inflammation.

Trials

The FDA approved WINLEVI based on evidence from two clinical trials of 1440 patients with acne vulgaris.

The trials were conducted at 99 sites in the United States, Poland, Romania, Bulgaria, Ukraine, Georgia, and Serbia. The benefit and side effects of WINLEVI were evaluated in two clinical trials of patients 9 to 58 years of age with acne vulgaris.

Patients applied WINLEVI or vehicle (placebo) cream twice daily for 12 weeks. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of WINLEVI in comparison to placebo was assessed after 12 weeks of treatment using the Investigator’s Global Assessment (IGA) score that measures the severity of disease (on a scale from 0 to 4) and a decrease in the number of acne lesions.

WINLEVI could become the next hero for the hormonal acne patients! It is expected to be launched in the U.S. in early 2021.

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