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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 studying whether onabotulinumtoxinA (BOTOX) is safe and effective for the temporary improvement of platysma prominence. Around 400 people in the US and Canada will be randomly assigned to either receive BOTOX or a placebo, and will be monitored for safety and effects monthly.

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
276,161 Total Patients Enrolled
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
78,851 Total Patients Enrolled

Frequently Asked Questions

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

What are the defined goals of this experiment?

"The objective of this trial is to observe the Composite Change as assessed by both the Clinician Platysma Scale and Participant Platysma Scale. This will be monitored over a period of approximately 120 days. Secondary outcomes include Change from baseline on the he Appearance of Neck and Lower Face Questionnaire: Impacts summary score, Percentage of Participants with achievement of a rating of Minimal or Mild according to investigator's assessment using Clinician Platysma Scale, and Change in improvement as rated by investigator using the Clinician Platysma Scale."

Answered by AI

Is this research study still recruiting participants?

"This study is no longer actively recruiting candidates. It was first posted on 7/8/2021 and was last edited on 8/30/2022. If you are exploring other studies, there are currently 3 trials actively admitting patients with platysma prominence and 69 studies for OnabotulinumtoxinA actively looking for participants."

Answered by AI

Is OnabotulinumtoxinA only being studied for this one condition?

"OnabotulinumtoxinA was first studied in the year 2012 at Rothman Institute. Since then there are a total of 18623 completed clinical trials. There are currently 69 active clinical trials, with many of these trials being conducted in Cobourg, Ontario."

Answered by AI

For what purpose is OnabotulinumtoxinA most often employed?

"While most commonly used as a urinary incontinence medication, onabotulinumtoxinA can also be used to treat conditions such as overactive bladder syndrome and spinal cord conditions."

Answered by AI

Has OnabotulinumtoxinA been cleared by the FDA?

"OnabotulinumtoxinA is a medication that has been found to be effective in clinical trials and has been determined to be safe."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
North Carolina
California
How old are they?
65+
18 - 65
What site did they apply to?
Dermatology Research Associates /ID# 229949
Ava MD - Santa Monica /ID# 229421
Other
Wilmington Dermatology Center /ID# 229246
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence
2021. "A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04949399.
~109 spots leftby Apr 2025
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