Setipiprant for Androgenetic Alopecia in Males: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 2a Trial.

ABSTRACT:

Purpose

To evaluate oral setipiprant versus placebo for scalp hair growth in men with androgenetic alopecia (AGA).

Patients and methods

Males aged 18 to 49 years with AGA were enrolled in a double-blind, multicenter, 32-week, phase 2a trial; randomized to twice-daily (BID) 1000-mg (2×500 mg for a total daily dose of 2000 mg) setipiprant tablets or placebo for 24 weeks; and assessed at weeks 4, 8, 16, and 24, with a week 32 follow-up. The study initially included a finasteride 1-mg once-daily group, removed by protocol amendment. Changes from baseline to week 24 in target area hair count (TAHC) and blinded Subject Self-Assessment (SSA) of target area photographs were coprimary efficacy endpoints. Hair growth was also evaluated using blinded Investigator Global Assessment (IGA

SUBMITTER: DuBois J 

PROVIDER: S-EPMC8526366 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature