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

ABSTRACT:

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. Participants were enrolled if they had 30 to 75 inflammatory lesions and 30 to 100 noninflammato

SUBMITTER: Hebert A 

PROVIDER: S-EPMC7177662 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature