Efficacy and Safety of Novel Botulinum Toxin Type A (Protoxin) in the Treatment of Moderate to Severe Glabellar Lines: A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Study.

ABSTRACT:

Background

A novel botulinum toxin type A (Protoxin; Protox Inc.) has been developed.

Objective

To evaluate the efficacy and safety of the newly developed Protoxin compared to the approved drug onabotulinumtoxinA (OBoNT) in moderate to severe glabellar lines.

Methods

Adults with a glabellar line Facial Wrinkle Scale (FWS) score of 2 (moderate) or 3 (severe) were enrolled in the study. Subjects were randomized in a 1:1 ratio to receive either Protoxin or OBoNT. A total of 20 units of botulinum toxin was injected at five sites in the glabellar region (4 units at each site). FWS scores were assessed at baseline and at weeks 4, 8, 12, and 16 post-injection. The primary endpoint was the proportion of subjects at week 4 who had a reduction of 2 or more points in FWS and a f

SUBMITTER: Son HS 

PROVIDER: S-EPMC12868749 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature