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.
NCT04994535
Allergan
Brief Summary:
Allergan
Condition or Disease:
Platysma Prominence
Intervention/Treatment:
Drug: OnabotulinumtoxinA Drug: PlaceboPhase:
Phase 3
Ages Eligible for Study:
18 Years and older (Adult,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
Calgary - Beacon Dermatology
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