Individuals aged 18 years and older with moderate or severe platysma prominence (vertical neck bands) on both left and right sides, may qualify to participate. Must be able to correctly and consistently maximally contract their platysma muscle. No appearance of vertical neck bands at rest, extreme hypertrophic platysma bands at maximum contraction, or excessively loose skin in the lower face, neck, and decolletage area, is also required.
Participants will receive investigational medication (active study drug) or placebo (with no active ingredient), via injection. Study medication and study-related procedures will be provided at no cost. Reimbursement for study-related expenses may be provided.
Study participation will last about 19 weeks and involve about 7 visits to the study centre.
The following information is from ClinicalTrials.gov
Last Update Posted: November 27, 2022
NCT04994535
Allergan
Brief 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.
Condition or Disease:
Platysma Prominence
Intervention/Treatment:
Drug: OnabotulinumtoxinAPhase:
Phase 3
Ages Eligible for Study:
18 Years and older (Adult)
Sexes Eligible for Study:
All
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
Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.
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