The Phase II multicenter, prospective, randomized, double-blind, vehicle controlled, dose ranging study will evaluate the efficacy and safety of clascoterone solution for the treatment of AGA in females. The six-month study enrolled 293 female subjects between 18-55 years of age with mild to moderate AGA in
AGA is a leading cause of hair loss in men and women. In AGA, high local concentrations of DHT bind to androgen receptors within the scalp hair follicles, resulting in shortening of the hair cycle and gradual miniaturization of scalp follicles in men and women with a genetic predisposition. Over time, these progressively smaller, thinner hair follicles are unable to produce new hair, thus resulting in AGA's characteristic patterned baldness. DHT dependent effects are considered, in most cases, reversible, such that AGA could be responsive to medical treatment with clascoterone solution through its proposed MOA of direct inhibition of testosterone and DHT binding to local hair follicle androgen receptors. Clascoterone solution has the potential to be the only topical androgen receptor inhibitor for use in both men and women with AGA if approved by the FDA.
'If approved, clascoterone solution will be the first new mechanism of action for the treatment of androgenetic alopecia in decades, offering dermatologists and patients a potentially unique therapeutic alternative,' said
About
About Clascoterone
Clascoterone, a new chemical entity, is a first-in-class topical androgen receptor inhibitor in late stage development for the treatment of androgenetic alopecia in females and males. Although Clascoterone's exact mechanism of action is unknown, laboratory studies suggest Clascoterone competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles.
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