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Neurotoxin

OnabotulinumtoxinA for Platysmal Bands

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

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 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

Side effects data

From 2014 Phase 4 trial • 250 Patients • NCT02096081
6%
Headache
2%
Facial Asymmetry
1%
Human ehrlichiosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
IncobotulinumtoxinA
OnabotulinumtoxinA

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BOTOXExperimental Treatment1 Intervention
BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle on Day 1
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be injected into the platysma muscle on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OnabotulinumtoxinA
2014
Completed Phase 4
~3920

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,004 Previous Clinical Trials
513,352 Total Patients Enrolled
AllerganLead Sponsor
781 Previous Clinical Trials
276,228 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
430 Previous Clinical Trials
155,672 Total Patients Enrolled
~104 spots leftby Sep 2025
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