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Clascoterone Cream First Topical to Target Androgen Receptors

Dermatology TimesDermatology Times, December 2021 (Vol. 42. No. 12)
Volume 42
Issue 12
Pages: 17

The recent approval of a topical androgen receptor inhibitor fills a longtime need in acne treatment.

The recent approval of a topical androgen receptor inhibitor fills a longtime need in acne treatment. Despite being 1 of the 4 pillars of acne pathogenesis, sebum production has been addressed only with oral agents. Leaving a crucial part of acne pathogenesis unaddressed very likely makes it more challenging for dermatologists to get patients as close to clear as possible, Julie Harper, MD, a board-certified dermatologist in private practice at the Dermatology and Skin Care Center of Birmingham in Alabama, told Dermatology Times®.

Clascoterone 1% cream (Winlevi; Sun Pharma) inhibits sebum production by targeting androgen receptors in sebaceous gland cells. The topical treatment, now available in the United States and FDA approved for patients over 12 years,1 provides an alternative to oral treatments such as isotretinoin. "Sebocyte suppression is a key step in the cascade that leads to increased [Cutibacterium] acnes bacterial activity and the cytokine pathways that contribute to inflammation,” Haleh Bakshandeh, MD, FAAD, founder of Dr B Dermatology in Beverly Hills, California, told Dermatology Times®.

This option is especially meaningful for male patients with acne. “Until now, we could only use androgen modulation in our female patients in the form of oral contraceptives and spironolactone,” Bakshandeh said.

Harper agreed: “This is the first time that we could even consider a ‘hormonal’ treatment for men,” she said. "This is a real game changer for the guys.Yes, this is an antiandrogen in the skin, but it is quickly metabolized in the skin and does not act as an antiandrogen systemically. Men do not have to be worried about systemic antiandrogen effects.”

In addition to adding flexibility to the topical acne armamentarium due to its mechanism of action, clascoterone cream is a good candidate for combination regimens, according to Harper.

“I would recommend using it in combination with other acne medications that work through different mechanistic pathways [eg, topical retinoids, benzoyl peroxide],” she said.“ It has a creamy feel and may even help offset some of the dryness and irritation that our patients experience with other topical treatments.”


Harper and Bakshandeh consultants and speakers for Sun Pharmaceuticals.


1 Sun Pharma announces availability of Winlevi (clascoterone) cream 1% in the U.S. for topical treatment of acne vulgaris. News release. Sun Pharmaceutical Industries Limited. November 1,2021. Accessed November 11, 2021.https://www. prnewswire.com/news-releases/sun-pharma-announces-availability-of-winlevi-clascoterone-cream-1-in-the-us-for-topi- cal-treatment-of-acne-vulgaris-301412078.html

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