A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 14, 30, 60, 90, and 120

Awards & highlights

Pivotal Trial

Summary

This trial is testing BOTOX injections to see if they can temporarily improve the appearance of prominent neck muscles. The study involves around 400 participants who will receive BOTOX injections. BOTOX works by relaxing the muscles, which can make the skin look smoother. Botulinum toxin (BOTOX) injections have been widely used for various medical and cosmetic purposes, including the treatment of muscle spasms, pain, and wrinkles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 14, 30, 60, 90, and 120

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 14, 30, 60, 90, and 120

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14, 30, 60, 90, and 120 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14

Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self-Assessment Using P-APPS at Maximum Contraction at Day 14

Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14

+1 more

Secondary study objectives

Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90

Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14

Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120

+9 more