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OnabotulinumtoxinA for Platysmal Bands

Bellaire Dermatology /ID# 249902, Bellaire, TX
Platysmal BandsOnabotulinumtoxinA - Drug
Eligibility
18+
All Sexes

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.

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

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1
Nipocalimab
1
SP16 (6mg)

Study Objectives

3 Primary · 19 Secondary · Reporting Duration: Day -14 to Day 120

Day 120
Number of Participants with Adverse Events
Day 120
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 Participant's Assessment using P-APPS at Maximum Contraction
Percentage of Participants who Achieved Grade 1 or 2 (Minimal or Mild) according to Investigator's Assessment using C-APPS
Percentage of Participants who Achieved Grade 1 or 2 (Minimal or Mild) according to Investigator's Assessment using C-APPS at Maximum Contraction
Percentage of Participants who Achieved at Least 1-Grade Improvement from Baseline Based on Investigator's Assessment Using C-APPS
Percentage of Participants who Achieved at Least 1-Grade Improvement from Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction
Percentage of Participants who Achieved at Least 1-Grade Improvement from Baseline Based on Participant's Assessment using P-APPS
Percentage of Participants who Achieved at Least 1-Grade Improvement from Baseline Based on Participant's Assessment using P-APPS at Maximum Contraction
Day 14
Change from baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts summary score
Change from baseline on the Appearance of Neck and Lower Face Questionnaire: Impacts summary score
Change from baseline on the he Appearance of Neck and Lower Face Questionnaire: Impacts summary score
Change in improvement as rated by investigator using the Clinician Platysma Scale
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
Composite Change as assessed by both the Clinician Platysma Scale and Participant Platysma Scale
Day 14
Percentage of Participants with Achievement of Responses of Not at all Bothered or a Little Bothered on the Bother Assessment Scale Item 1
Percentage of Participants with Responses of "Satisfied" or "Very Satisfied" on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (effect of treatment)
Percentage of Participants with Responses of 'Not at all Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands)
Percentage of Participants with Responses of 'Not at all bothered' or 'A little bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline)
Percentage of Participants with achievement of a rating of Minimal or Mild according to investigator's assessment using Clinician Platysma Scale
Percentage of Participants with achievement of responses of Not at all bothered or A little bothered on the Bother Assessment Scale Item 2
Percentage of patients with satisfaction with appearance of the neck and lower face as measured by The Appearance of Neck and Lower Face Questionnaire: Satisfaction

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
AI-09 3.5U
2
Nipocalimab
1
SP16 (6mg)

Side Effects for

OnabotulinumtoxinA
4%Headache
2%Facial Asymmetry
1%Atypical pneumonia
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT02096081) in the OnabotulinumtoxinA ARM group. Side effects include: Headache with 4%, Facial Asymmetry with 2%, Atypical pneumonia with 1%.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

BOTOX
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

426 Total Participants · 2 Treatment Groups

Primary Treatment: OnabotulinumtoxinA · Has Placebo Group · Phase 3

BOTOX
Drug
Experimental Group · 1 Intervention: OnabotulinumtoxinA · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day -14 to day 120

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
275,401 Total Patients Enrolled
ALLERGAN INC.Study DirectorAllergan
74 Previous Clinical Trials
77,894 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Texas40.0%
California40.0%
New Jersey20.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Moradi MD /ID# 24471950.0%
Luxurgery /ID# 24492450.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
Why did patients apply to this trial?
  • "i hope this trial can help with my symptoms"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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