In August 2020, the FDA approved first-in-class Winlevi (Clascoterone 1% Cream) to treat moderate-to-severe hormonal acne in patients 12 years and over.
Acne affects up to 50 million Americans a year. The condition causes oily skin, blackheads, whiteheads, pimples, and inflammation. It is most common among teenagers but can affect people of all ages. Acne can be persistent and may require medical treatment.
The major causes of acne include:
- Skin skin cell and clogged pores
- Excess oil
WHAT IS WINLEVI?
Winlevi is an androgen receptor inhibitor meant to treat acne vulgaris in both males and females. The drug is a topical cream and should be available early next year. Dermatologists may use Winlevi in combination with other treatments to meet individual needs.
WHAT MAKES WINLEVI UNIQUE?
Winlevi will be the first topical androgen receptor inhibitor available on the market—giving it the first-in-class label. Androgens are a group of reproductive hormones that can cause inflammation and stimulate oil (sebum) production. The excess oil clogs pores and feeds bacteria, which can lead to breakouts. Winlevi works by restricting the effects of the hormones.
Current treatments for hormonal acne include retinoids, antibiotics, anti-inflammatories, salicylic acid, benzoyl peroxide, and birth control. It has been nearly 40 years since an acne therapy based on a new mechanism of action (MOA) has been released on the market. And with antibiotic-resistant bacteria becoming a worsening problem, the approval of a non-antibiotic treatment is beneficial.
Clinical trials showed a reduction in symptoms within 12 weeks when used twice a day. Also, the subjects tolerated Winlevi well. The most common side effects were dryness, itchiness, peeling, and reddening of the skin.
If you suffer from stubborn acne and would like to learn more about Winlevi or other treatments, please contact me for a personalized consultation.Previous Post