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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

Study Summary

This trial is testing whether a botulinum toxin can improve the appearance of a sagging neck muscle. Around 400 people will be enrolled at 35 sites across the US, Europe, and Russia, and will be randomly assigned to receive either the toxin or a placebo. There will be monthly follow-up visits.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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
275,367 Total Patients Enrolled
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
78,057 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project still recruiting participants?

"The online registry, clinicaltrials.gov, reflects that this study is still enrolling patients. The listing was first made on August 10th, 2021 with the most recent update being on November 3rd, 2022."

Answered by AI

What medical conditions does OnabotulinumtoxinA commonly treat?

"OnabotulinumtoxinA is most often used to ameliorate urinary incontinence, however it can also serve as a treatment for spinal cord issues, botox, and overactive bladder syndrome."

Answered by AI

What is the Food and Drug Administration's stance on OnabotulinumtoxinA?

"OnabotulinumtoxinA is considered safe, as it has been studied in Phase 3 trials. This level of investigation means there is data supporting both its efficacy and safety."

Answered by AI

Has OnabotulinumtoxinA been used in other research studies?

"In 2012, OnabotulinumtoxinA was first studied at Rothman Institute. Since then, there have been 18623 completed trials. Currently, there are 69 trials in progress, with a significant concentration in Bellaire, Texas."

Answered by AI

Is this clinical trial widespread in the United States?

"This trial has 27 enrolment sites, some of which include Bellaire Dermatology in Bellaire, DermResearch Inc. in Austin, TX, and Total Skin and Beauty Derm Ctr in Birmingham."

Answered by AI

How many test subjects are included in this clinical trial?

"This clinical trial requires 400 individuals that match the pre-determined inclusion criteria. Allergan, the sponsor, will be organizing the trial from multiple locations including Bellaire Dermatology /ID# 249902 in Bellaire, Texas and DermResearch, Inc. Austin, TX /ID# 249904 in Austin, Alabama."

Answered by AI

Why did researchers design this trial in this way?

"This trial will last for 120 days and will aim to assess Composite Change as determined by both the Clinician Platysma Scale and the Participant Platysma Scale. Additionally, this study will also look at secondary outcomes like the satisfaction of patients with the appearance of their neck and lower face, as well as the percentage of participants who respond "not at all bothered" or "a little bothered" on the Bother Assessment Scale Item 1. Lastly, the trial will also evaluate change in improvement as rated by the investigator using the Clinician Platysma Scale."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Texas
California
How old are they?
18 - 65
What site did they apply to?
Moradi MD /ID# 244719
Luxurgery /ID# 244924
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

i hope this trial can help with my symptoms.
PatientReceived no prior treatments
~119 spots leftby Mar 2025