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

  • STATUS
    Recruiting
  • End date
    Oct 23, 2022
  • participants needed
    400
  • sponsor
    Allergan
Updated on 24 September 2021

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 in the United States and Canada.

Participants will receive either intramuscular injections of onabotulinumtoxinA (BOTOX) or placebo.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.

Details
Condition Platysma Prominence
Treatment Placebo, OnabotulinumtoxinA
Clinical Study IdentifierNCT04949399
SponsorAllergan
Last Modified on24 September 2021

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)
Anticipated need for surgery or overnight hospitalization during the study
Females who are pregnant or breastfeeding and are considering becoming
pregnant or donating eggs during the study
Known immunization or hypersensitivity to any botulinum toxin serotype
History of clinically significant (per investigator's judgment) drug or
alcohol abuse within the last 6 months
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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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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