Platysma Prominence - Vertical Neck Bands
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Platysma Prominence - Vertical Neck Bands
M21-309 Enrolling

Platysma Prominence (Vertical Neck Bands) Research Trial 1 (19 Weeks)


Age: 18 Years

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 décolletage 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.


Official Title

A Phase 3 Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence

ClinicalTrials.gov ID

NCT04949399

Sponsor

Allergan

Study Description

  • Brief Summary:

    Allergan

  • Condition or Disease:

    Platysma Prominence

  • Intervention/Treatment:

    Drug: OnabotulinumtoxinA Drug: Placebo
  • Phase:

    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


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Mani Raman, MD, FRCPC, DABD

Dermatologist

Dr. Melinda Gooderham, MSc, MD, FRCPC

Dermatologist

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