A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With 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 across approximately 35 sites in USA, Belgium, Canada, Germany 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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 426
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles-Capitale
    • Jette, Bruxelles-Capitale, Belgium, 1090
      • UZ Brussel /ID# 229125
  • Limburg
    • Sint-Truiden, Limburg, Belgium, 3800
      • Medical Skincare /ID# 229129
  • West-Vlaanderen
    • Knokke-Heist, West-Vlaanderen, Belgium, 8301
      • Duinbergen Clinic /ID# 231282
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3E 0B2
      • Beacon Dermatology Inc /ID# 231675
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 4E1
      • Pacific Derm /ID# 231019
  • Ontario
    • Toronto, Ontario, Canada, M5R 3N8
      • Sweat Clinics of Canada /ID# 231021
    • Woodbridge, Ontario, Canada, L4L 8E2
      • Bertucci MedSpa Inc. /ID# 231020
• Germany
  • Kassel, Germany, 34117
    • Noahklinik GmbH /ID# 232311
  • Muenchen, Germany, 80333
    • Hautok and Hautok-cosmetics /ID# 229573
  • Muenchen, Germany, 80539
    • Privatpraxis fuer Dermatologie und Aesthetik /ID# 230901
  • Bayern
    • Muenchen, Bayern, Germany, 80333
      • Studienzentrum Theatiner46 /ID# 229570
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Rosenpark Research /ID# 229568
• United Kingdom
  • Coatbridge, United Kingdom, ML5 3AP
    • Waverley Medical Practice /ID# 229590
  • Sutton Coldfield, United Kingdom, B74 2UG
    • MediZen Premier Aesthetic Clinic /ID# 229588
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Derm Ctr /ID# 249905
  • California
    • Los Angeles, California, United States, 90025-1708
      • Westside Aesthetics /ID# 231196
    • Los Angeles, California, United States, 90069
      • Skin Care and Laser Physicians of Beverly Hills /ID# 231194
    • Vista, California, United States, 92083-6030
      • Moradi MD /ID# 244719
  • Florida
    • Coral Gables, Florida, United States, 33146-1837
      • Skin Research Institute LLC /ID# 231195
    • Miami, Florida, United States, 33137-3254
      • Skin and Cancer Associates, LLP /ID# 231189
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research /ID# 231191
    • Naperville, Illinois, United States, 60563-3018
      • Oak Dermatology in Naperville /ID# 231193
  • Louisiana
    • New Orleans, Louisiana, United States, 70130-4353
      • Etre Cosmetic Dermatology and Laser Center /ID# 231192
  • Michigan
    • Birmingham, Michigan, United States, 48009-6301
      • BOYD Beauty Birmingham /ID# 231190
    • Clinton Township, Michigan, United States, 48038
      • Michigan Center for Research Corporation /ID# 249911
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC /ID# 249903
  • New York
    • Mount Kisco, New York, United States, 10549-3028
      • The Center for Dermatology Cosmetics & Laser Surgery /ID# 231187
    • New York, New York, United States, 10021-4951
      • Luxurgery /ID# 244924
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Clinical Research Center of the Carolinas /ID# 231197
  • Tennessee
    • Nashville, Tennessee, United States, 37215-2885
      • Tennessee Clinical Research Center /ID# 244720
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch, Inc. Austin, TX /ID# 249904
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates /ID# 249902
    • Houston, Texas, United States, 77056-4129
      • Austin Institute for Clinical Research at SBA Dermatology /ID# 232104
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research /ID# 244936

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
Placebo Comparator: Placebo; Placebo will be injected into the platysma muscle on Day 1	Drug: Placebo; Saline injection
Experimental: BOTOX; BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle on Day 1	Drug: OnabotulinumtoxinA; Injection; Other Names: BOTOX

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 causal relationship with this treatment.	Enrollment 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, at Maximum Contraction at Day 14	The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.	Day 14
Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14	The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.	Day 14
Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self-Assessment Using P-APPS at Maximum Contraction at Day 14	The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120	The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.	Day 14, 30, 60, 90, and 120
Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Self-Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120	The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.	Day 14, 30, 60, 90, and 120
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) at Day 14	The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied).	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) at Day 14	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) at Day 14	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 at Day 14	The ANLFQ: Impacts scale assesses the psychosocial impact due to the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher summary scores (range: 7-35) indicating greater negative psychosocial impact from the appearance of the neck and lower face. For change from baseline in the ANLFQ: Impacts summary score, positive values indicate worsening and negative values indicate improvement in the psychosocial impact.	Day 14
Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120	The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.	Day 14, 30, 60, 90, and 120
Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120	The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.	Day 14, 30, 60, 90, and 120
Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14	The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.	Day 14
Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14	The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied).	Day 14
Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14	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 ANLFQ: Impacts Summary Score at Days 30, 60, and 90	The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher scores indicating greater negative impact from the appearance of the neck and lower face.	Days 30, 60, and 90

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): June 14, 2023

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

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: M21-310; 2021-000240-22 (EudraCT Number)

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