Dr. Leyden is Emeritus Professor CE of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia
Topical clascoterone is the first approved molecule for acne therapy that has a primary effect on sebaceous gland function due to its anti-androgen effect on androgen receptors. Researchers have been searching for this type of topical drug as long as I have been involved in acne research. Numerous other compounds failed, mainly because they could not deliver sufficient drug to the sebaceous glands or because they caused systemic adverse hormonal effects. Clascoterone is metabolized to cortexolone, a molecule naturally found in human cells, and thus is free of systemic side effects.
No studies have been done to determine the magnitude of sebum suppression achieved with clascoterone. Nor have been studies been done to determine if greater efficacy can be achieved at a higher concentration.
Importantly, in clinical trials for the FDA, clascoterone agent was evaluated as a monotherapy. Acne is a multifactorial disease, and this new agent will and should be used in combination with other classes of drugs that counteract the other pathways in its pathophysiology.
Disclosures
Dr. Leyden initially advised Medicis (now Valeant) to make an arrangement with Cosmo Pharmaceuticals, the Italian company that was developing clascoterone. He has served as an advisor to Cassiopea but has no ongoing relationships.
Archive
Commentary: A new treatment with great promise
By James J. Lyden, MD
Dr. Lyden responds to “First-in-class clascoterone opens a new door for acne care”
Dr. Leyden is Emeritus Professor CE of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia
Topical clascoterone is the first approved molecule for acne therapy that has a primary effect on sebaceous gland function due to its anti-androgen effect on androgen receptors. Researchers have been searching for this type of topical drug as long as I have been involved in acne research. Numerous other compounds failed, mainly because they could not deliver sufficient drug to the sebaceous glands or because they caused systemic adverse hormonal effects. Clascoterone is metabolized to cortexolone, a molecule naturally found in human cells, and thus is free of systemic side effects.
No studies have been done to determine the magnitude of sebum suppression achieved with clascoterone. Nor have been studies been done to determine if greater efficacy can be achieved at a higher concentration.
Importantly, in clinical trials for the FDA, clascoterone agent was evaluated as a monotherapy. Acne is a multifactorial disease, and this new agent will and should be used in combination with other classes of drugs that counteract the other pathways in its pathophysiology.
Disclosures
Dr. Leyden initially advised Medicis (now Valeant) to make an arrangement with Cosmo Pharmaceuticals, the Italian company that was developing clascoterone. He has served as an advisor to Cassiopea but has no ongoing relationships.