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OnabotulinumtoxinA for Platysmal Bands
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.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 4 trial • 250 Patients • NCT02096081Trial Design
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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."
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."
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."
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."
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."
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."
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."
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