Alcanza Clinical Research

Accel Research Sites is proud to announce that a drug we studied—Winlevi®—will soon be available in the U.S.

Winlevi® is a topical acne treatment from Cassiopea. Its approval from the Food and Drug Administration marks the first new mechanism of action in acne treatment in nearly 40 years.

Winlevi®, clascoterone cream 1%, is a topical androgen receptor inhibitor. It targets receptors of androgen, a hormone that drives sebum production and inflammation, limiting its effect. The treatment is intended for males and females 12 years and older.

In clinical trials, Winlevi® showed reduction in acne lesions and was well tolerated, with the most frequent skin reaction as mild erythema. Accel Research Site’s St. Petersburg Clinic served as a study location for the Cassiopea trial.

According to the American Academy of Dermatology Association, acne is the most common skin condition in the U.S., affecting 50 million Americans each year. Cassiopea specializes in developing prescription drugs with novel mechanisms of action to address longstanding dermatological conditions, including acne.

“We at Accel Research Sites extend our congratulations to Cassiopea,” said Dr. Gigi C. Lefebvre, the principal investigator. “We were proud to participate in this research, and we are happy to know that because of the hard work of our clinical staff and the willingness of our volunteers, thousands of Americans will soon have access to this new treatment. Wins like this are what clinical trials are all about.”