Efficacy and Safety of 1% Clascoterone Cream in Patients Aged > 12 Years With Acne Vulgaris.

Background: Two randomized phase 3 studies evaluated efficacy and safety of 1% clascoterone cream, a topical androgen receptor inhibitor, in patients aged ≥9 years with moderate-to-severe facial acne vulgaris after 12 weeks of treatment.

Objectives: To present a pooled data analysis of the efficacy and safety of 1% clascoterone cream after 12 weeks of treatment in patients aged ≥12 years from the 2 phase 3 trials.

Methods: Patients were randomized 1:1 to twice-daily treatment of the whole face with clascoterone or vehicle.

Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris.

Background: Androgens foster acnegenic pathways.

Objective: To assess the long-term safety of an androgen receptor inhibitor, clascoterone cream, 1%, in patients who participated in phase 3 studies.

Methods: Clascoterone cream was applied twice daily for up to 9 months to the face or trunk, or both.

Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials.

Importance: Acne is a common, multifactorial skin condition, and treatments with novel mechanisms have been elusive.

Objective: To assess the safety and efficacy of clascoterone cream, 1%, a novel topical androgen receptor inhibitor, in 2 phase 3 randomized clinical trials (CB-03-01/25 and CB-03-01/26).

Design, Setting, And Participants: Two identical, multicenter, randomized, vehicle-controlled, double-blind, phase 3 studies conducted from November 2015 to April 2018 evaluated the efficacy and safety of use of clascoterone cream, 1%, in males and nonpregnant females 9 years and older with moderate or severe facial acne as scored on the Investigator's Global Assessment scale.