Long-term Efficacy and Safety of Liquid AbobotulinumtoxinA Formulation for Moderate-to-Severe Glabellar Lines: A Phase III, Double-Blind, Randomized, Placebo-Controlled and Open-Label Study.

ABSTRACT:

Background

A ready-to-use liquid formulation of abobotulinumtoxinA (aboBoNT-A solution) has been developed.

Objectives

The aim of this study was to assess the long-term efficacy and safety of aboBoNT-A solution for the treatment of glabellar lines.

Methods

This was a multicenter, multinational, Phase III study (NCT02493946), with randomized double-blind placebo-controlled (DBPC; 2:1 aboBoNT-A solution 50 U/placebo) and open-label (4 cycles aboBoNT-A solution) periods; additional patients were recruited into the open-label period. Patients were 18 to 65 years old, BoNT-naïve, and dissatisfied/very dissatisfied with moderate/severe glabellar lines at maximum frown. Investigator's live assessment (primary endpoint)/subject's self-assessment of glabellar line severity at

SUBMITTER: Kestemont P 

PROVIDER: S-EPMC8844979 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature