History
C17α esters of 11-deoxycortisol were unexpectedly found to possess antiandrogenic activity. Clascoterone, also known as cortexolone 17α-propionate, was selected for development based on its optimal drug profile. The medication was approved by the US Food and Drug Administration (FDA) for the treatment of acne in August 2020.The FDA approved clascoterone based on evidence from two clinical trials (Trial 1/NCT02608450 and Trial 2/NCT02608476) of 1,440 participants 9 to 58 years of age with acne vulgaris. The trials were conducted at 99 sites in the United States, Poland, Romania, Bulgaria, Ukraine, Georgia, and Serbia. Participants applied clascoterone or vehicle (placebo) cream twice daily for 12 weeks. Neither the participants nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of clascoterone in comparison to placebo was assessed after 12 weeks of treatment using the Investigators 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. Society and culture
Names
Clascoterone is the generic name of the drug and its INN and USAN. Research
Clascoterone has been suggested as a possible treatment for hidradenitis suppurativa (acne inversa), an androgen-dependent skin condition. References
External links
"Clascoterone". Drug Information Portal. U.S. National Library of Medicine.
Clascoterone, sold under the brand name Winlevi, is an antiandrogen medication which is used topically in the treatment of acne. It is also under development in a higher concentration for the treatment of androgen-dependent scalp hair loss, under the brand name Breezula. The medication is used as a cream by application to the skin, for instance the face and scalp.Clascoterone is an antiandrogen, or antagonist of the androgen receptor (AR), the biological target of androgens such as testosterone and dihydrotestosterone. It shows minimal systemic absorption when applied to skin.The medication, developed by Cassiopea and Intrepid Therapeutics, was approved by the US Food and Drug Administration (FDA) for acne in August 2020. The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. Medical uses
Clascoterone is indicated for the topical treatment of acne vulgaris in females and males age 12 years and older. It is applied to the affected skin area in a dose of 1 g cream (or 10 mg clascoterone) twice per day, once in the morning and once in the evening. The medication should not be used ophthalmically, orally, or vaginally.Two large phase 3 randomized controlled trials evaluated the effectiveness of clascoterone for the treatment of acne over a period of 12 weeks. Clascoterone decreased acne symptoms by about 8 to 18% more than placebo. The defined treatment success endpoint was achieved in about 18 to 20% of individuals with clascoterone relative to about 7 to 9% of individuals with placebo.