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

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

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.

Study Overview

• Status: Completed
• Conditions: Platysma Prominence
• Intervention / Treatment: Drug: Placebo; Drug: OnabotulinumtoxinA

• Study Type: Interventional
• Enrollment (Actual): 408
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Humphrey Cosmetic Dermatology /ID# 229522
  • Ontario
    • Burlington, Ontario, Canada, L7N 3N2
      • Dermetics Cosmetic Dermatology /ID# 229482
    • Cobourg, Ontario, Canada, K9A 0Z4
      • Dr Melinda Gooderham Medicine Profession /ID# 229456
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Center For Dermatology /ID# 229481
• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Advanced Research Associates - Glendale /ID# 229256
    • Scottsdale, Arizona, United States, 85255-4134
      • Clear Dermatology & Aesthetics Center /ID# 229252
  • California
    • Encino, California, United States, 91436-2124
      • Clinical Testing of Beverly Hills /ID# 229946
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates /ID# 229949
    • Newport Beach, California, United States, 92663
      • Steve Yoelin MD Medical Associate Inc /ID# 229420
    • San Diego, California, United States, 92121-2119
      • Cosmetic Laser Dermatology /ID# 229245
    • Santa Monica, California, United States, 90404-2208
      • Ava T. Shamban MD - Santa Monica. /ID# 229421
    • Solana Beach, California, United States, 92075-2228
      • Art of Skin MD /ID# 229255
  • Connecticut
    • Westport, Connecticut, United States, 06880
      • DMR Research PLLC /ID# 229938
  • Florida
    • Bradenton, Florida, United States, 34209-5642
      • Susan H. Weinkle MD /ID# 229419
    • West Palm Beach, Florida, United States, 33401-2712
      • Research Institute of the Southeast, LLC /ID# 229234
  • Indiana
    • Indianapolis, Indiana, United States, 46260-2386
      • Laser and Skin Surgery Center of Indiana /ID# 229515
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Coleman Center For Cosmetic Dermatologic Surgery /ID# 229414
    • New Orleans, Louisiana, United States, 70115
      • Delricht Research /ID# 229248
  • Maryland
    • Baltimore, Maryland, United States, 21208-6391
      • Aesthetic Center at Woodholme /ID# 229836
    • Hunt Valley, Maryland, United States, 21030-3216
      • Maryland Dermatology Laser, Skin, & Vein Institute /ID# 229260
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • Image Dermatology, P.C. /ID# 229244
  • New York
    • New York, New York, United States, 10016-4974
      • Laser & Skin Surgery Center of New York /ID# 229423
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517-9901
      • Aesthetic Solutions /ID# 229241
    • Wilmington, North Carolina, United States, 28403
      • Wilmington Dermatology Center /ID# 229246
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Aventiv Research Dublin /ID# 229254
  • Pennsylvania
    • Newtown Square, Pennsylvania, United States, 19073-2228
      • KGL Skin Study Center, LLC /ID# 229253
  • Tennessee
    • Nashville, Tennessee, United States, 37203-1513
      • Nashville Center for Laser and Facial Surgery /ID# 229237
  • Texas
    • Dallas, Texas, United States, 75231
      • Dallas Plastic Surgery Institute /ID# 229258
  • Virginia
    • Arlington, Virginia, United States, 22209
      • SkinDC /ID# 229251
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research /ID# 229261

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BOTOX; BOTOX will be injected into the platysma muscle on Day 1	Drug: OnabotulinumtoxinA; Injection; Other Names: BOTOX
Placebo Comparator: Placebo; Placebo will be injected into the platysma muscle on Day 1	Drug: Placebo; Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.	Day -14 to Day 120
Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement from Baseline Based on Both Investigator's Assessment using C-APPS and Participant's Self-Assessment using P-APPS	The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence and is a static measurement encompassing visual examination of the platysma muscle ranging from 1 - Minimal to 5- Extreme. The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence and is a single-item measure that is accompanied by a 5-grade photonumeric scale ranging from 1 - Minimal to 5 - Extreme.	Day 1 to Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Responses of "Satisfied" or "Very Satisfied" on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (effect of treatment)	The ANLFQ is a 11-item measure that assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face.	Day 14
Percentage of Participants with Responses of 'Not at all bothered' or 'A little bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline)	The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).	Day 14
Percentage of Participants with Responses of 'Not at all Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands)	The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).	Day 14
Change from baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts summary score	The Appearance of Neck and Lower Face Questionnaire: Impacts is a 7-item measure that assesses the psychosocial impact of the appearance of the neck and lower face.	Day 1 to Day 14
Percentage of Participants who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment using P-APPS	The P-APPS evaluates platysma prominence and is a single-item measure that is accompanied by a 5-grade photonumeric scale ranging from 1 - Minimal to 5 - Extreme.	Day 1 to Day 120
Percentage of Participants who Achieved at Least 1-Grade Improvement from Baseline Based on Investigator's Assessment Using C-APPS	The C-APPS evaluates platysma prominence and is a static measurement encompassing visual examination of the platysma muscle ranging from 1 - Minimal to 5- Extreme.	Day 1 to Day 120
Percentage of Participants who Achieved at Least 1-Grade Improvement from Baseline Based on Participant's Assessment using P-APPS	The P-APPS evaluates platysma prominence and is a single-item measure that is accompanied by a 5-grade photonumeric scale ranging from 1 - Minimal to 5 - Extreme.	Day 1 to Day 120
Percentage of Participants who Achieved Grade 1 or 2 (Minimal or Mild) according to Investigator's Assessment using C-APPS	The C-APPS evaluates platysma prominence and is a static measurement encompassing visual examination of the platysma muscle ranging from 1- Minimal to 5- Extreme.	Day 1 to Day 120

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: ALLERGAN INC., Allergan

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: OnabotulinumtoxinA; BOTOX; Platysma Prominence
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: M21-309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No