FDA Approved A New Active Ingredient To Target Hormonal Acne

Exfoliants, retinoids, antioxidants and standard skincare ingredients can help to minimize breakouts, but targeting the actual hormone fluctuations that cause this condition is a largely untapped area; there actually hasn’t been a new clinical acne drug with an innovative mechanism for 40 years until now. 

The FDA has just approved Winlevi made by Cassiopea SpA, which is a topical cream that has been designed to treat hormonal acne with its brand new active ingredient clascoteron that does not require any antibiotics or oral medications. This synthetic ingredient can inhibit androgens like DHT and testosterone which can be the culprits behind hormonal acne. In clinical study, this ingredient appeared to keep those hormones from going amuck to help control acne, with minimal side effects. When using the topical cream twice a day the only frequent reaction was some redness and scaling, which is rather common in many prescription topicals. 

What’s more, is that clascoteron doesn’t require any sort of oral medications. There are plenty of acne-fighting ingredients and topicals, but those that approach the androgens themselves are rather limited. Meaning that oral antibiotics have been the go-to for hormonal acne, especially in severe cases until now as this topical cream has the same clinical strength. 

Micheal Gold, MD, who is a board-certified dermatologist, investigator and medical director at the Tennessee Clinical Research Center says, "This game-changing topical drug offers a non-antibiotic approach to people with acne, by targeting the androgen receptors directly in the skin. It fills a long-standing gap in acne therapy," adding that: "After 40 years, it provides a much-anticipated, complementary new approach to treat acne."

Diana Harbort, CEO of Cassiopea, said: "This milestone approval marks the introduction of a new class of topical medication in Dermatology. Dermatologists have said targeting androgen hormonal activity in the skin is 'the holy grail' of acne treatment for both males and females. We are proud to bring this new innovation to acne patients. This approval rewards many years of hard work and positions Cassiopea as a leader in Dermatology. Now we look forward to expanding our franchise and advancing our next investigational drug candidate for androgenetic alopecia."