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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 maximum frown, patient satisfaction with glabellar line appearance, and FACE-Q patient-reported scales (facial appearance overall, psychological well-being, aging) were assessed. Adverse events were monitored. Analyses were performed on DBPC and long-term analysis (LTA; all patients receiving ≥1 aboBoNT-A solution injection) populations.Results
Responder rates for the investigator's live assessment, the subject's self-assessment, and patient satisfaction were consistent at Day 29 postinjection across repeat LTA cycles (82.2%-87.8%, 62.8%-80.6%, and 72.2%-87.8%, respectively), with statistically significantly higher responder rates vs placebo (DBPC cycle: 81.6% vs 0.8%, 68.1% vs 2.3%, and 83.1% vs 5.7%, respectively; all P < 0.0001). Consistent improvements on FACE-Q scales occurred with repeat cycles (DBPC cycle: aboBoNT-A solution vs placebo, P < 0.0001). No new or unexpected adverse events, or neutralizing antibodies, were observed.Conclusions
These results support the long-term efficacy and safety of aboBoNT-A solution, and its superiority over placebo, for treatment of glabellar lines in adults.Level of evidence: 1
SUBMITTER: Kestemont P
PROVIDER: S-EPMC8844979 | biostudies-literature | 2022 Feb
REPOSITORIES: biostudies-literature
Kestemont Philippe P Hilton Said S Andriopoulos Bill B Prygova Inna I Thompson Catherine C Volteau Magali M Ascher Benjamin B
Aesthetic surgery journal 20220201 3
<h4>Background</h4>A ready-to-use liquid formulation of abobotulinumtoxinA (aboBoNT-A solution) has been developed.<h4>Objectives</h4>The aim of this study was to assess the long-term efficacy and safety of aboBoNT-A solution for the treatment of glabellar lines.<h4>Methods</h4>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; addit ...[more]