A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence

  • STATUS
    Recruiting
  • End date
    May 22, 2023
  • participants needed
    400
  • sponsor
    Allergan
Updated on 14 May 2022

Summary

The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence.

Study doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study across approximately 35 sites in USA, Belgium, Canada, Germany, Russia, and the UK.

Participants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study.

Participants will attend regular monthly visits during the study at the study site.

Details
Condition Platysma Prominence
Treatment Placebo, OnabotulinumtoxinA
Clinical Study IdentifierNCT04994535
SponsorAllergan
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must voluntarily sign and date an informed consent, approved by an independent
ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any
screening or study specific procedures
Are willing and able to comply with procedures required in the protocol
Adult male or female, at least 18 years old at the time of signing the informed consent
Good health as determined by medical history, physical examination, vital signs, and
investigator's judgment

Exclusion Criteria

Any medical condition that may put the participant at increased medical risk with exposure
to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic
lateral sclerosis, or any other condition that might interfere with neuromuscular function
Participant has an anticipated need for treatment with botulinum toxin of any serotype for
any indication during the study (other than study intervention)
Females who are pregnant or breastfeeding and are considering becoming pregnant or donating
Anticipated need for surgery or overnight hospitalization during the study
eggs during the study
History of clinically significant (per investigator's judgment) drug or alcohol abuse
within the last 6 months
Known immunization or hypersensitivity to any botulinum toxin serotype
Lower facial and neck hair, scarring (e.g., acne), or other abnormal variations that may
interfere with photography (such that photograph is not acceptable)
Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of
interest
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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