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Neurotoxin

OnabotulinumtoxinA for Platysmal Bands

Phase 3
Waitlist Available
Research Sponsored by Allergan
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 to day 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 will include about 400 participants who will receive BOTOX. BOTOX works by temporarily stopping muscles from moving, which can make the skin look smoother. BOTOX has been used for over a decade to improve the appearance of facial lines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -14 to day 120
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -14 to day 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
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
Number of Participants with Adverse Events
Secondary study objectives
Change from baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts summary score
Percentage of Participants who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment using P-APPS
Percentage of Participants who Achieved Grade 1 or 2 (Minimal or Mild) according to Investigator's Assessment using C-APPS
+5 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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BOTOXExperimental Treatment1 Intervention
BOTOX 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?

AllerganLead Sponsor
781 Previous Clinical Trials
276,246 Total Patients Enrolled
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
79,136 Total Patients Enrolled
~94 spots leftby Nov 2025
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