BOTOX® for the Treatment of Platysma Prominence

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence

To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence.

Study Overview

• Status: Completed
• Conditions: Platysma Prominence
• Intervention / Treatment: Drug: Placebo; Drug: BOTOX® purified neurotoxin complex

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Humphrey Cosmetic Dermatology /ID# 236591
    • Vancouver, British Columbia, Canada, V6H 4E1
      • Pacific Derm /ID# 238236
  • Ontario
    • Burlington, Ontario, Canada, L7N 3N2
      • Dermetics Cosmetic Dermatology /ID# 236899
    • Toronto, Ontario, Canada, M5R 3N8
      • Sweat Clinics of Canada /ID# 236590
    • Woodbridge, Ontario, Canada, L4L 8E2
      • Bertucci MedSpa Inc. /ID# 236523
• United States
  • California
    • Los Angeles, California, United States, 90069
      • Skin Care and Laser Physicians of Beverly Hills /ID# 236518
  • Florida
    • Coral Gables, Florida, United States, 33146-1837
      • Skin Research Institute LLC /ID# 238126
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research /ID# 238165
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • MD Laser Skin & Vein /ID# 234532
  • New York
    • Mount Kisco, New York, United States, 10549-3028
      • The Center for Dermatology Cosmetics & Laser Surgery /ID# 235624
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • The Practice of Brian S. Biesman MD PLLC /ID# 234461
  • Texas
    • Dallas, Texas, United States, 75231
      • Dallas Plastic Surgery Institute /ID# 236528

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period

• A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies:

  1. Not a woman of childbearing potential (WOCBP) OR
  2. A WOCBP who agrees to follow the studies contraceptive guidance during the treatment and follow-up period through study exit.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this study's protocol

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
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
• Females who are pregnant, nursing, or planning a pregnancy during the study
• Known immunization or hypersensitivity to any botulinum toxin serotype
• History of alcohol or drug abuse within 12 months of the study
• Participant has tattoos, jewelry, or clothing that cannot be removed, and that obscure the neck

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.	Drug: Placebo; Placebo injections.
Experimental: BOTOX® Low Dose; Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.	Drug: BOTOX® purified neurotoxin complex; BOTOX® superficial intramuscular injections.; Other Names: Botulinum toxin type A purified neurotoxin complex
Active Comparator: BOTOX® High Dose; Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.	Drug: BOTOX® purified neurotoxin complex; BOTOX® superficial intramuscular injections.; Other Names: Botulinum toxin type A purified neurotoxin complex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS)	The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis.	Day 14
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)	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. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events are defined as any event that began or worsened in severity on or after the first dose of study drug or any AE that was present before the first dose of study intervention, but increased in severity or became serious after the first dose of study intervention.	From the first dose of study drug up to end of study (up to Day 120)
Pulse Rate at Baseline	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.	Baseline (Day 1)
Change From Baseline in Pulse Rate at Day 7	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.	Baseline; Day 7
Change From Baseline in Pulse Rate at Day 14	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.	Baseline; Day 14
Change From Baseline in Pulse Rate at Day 30	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.	Baseline; Day 30
Change From Baseline in Pulse Rate at Day 60	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.	Baseline; Day 60
Change From Baseline in Pulse Rate at Day 90	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.	Baseline; Day 90
Change From Baseline in Pulse Rate at Day 120	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.	Baseline; Day 120
Systolic and Diastolic Blood Pressure (BP) at Baseline	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline (Day 1)
Change From Baseline in Systolic and Diastolic BP at Day 7	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline; Day 7
Change From Baseline in Systolic and Diastolic BP at Day 14	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline; Day 14
Change From Baseline in Systolic and Diastolic BP at Day 30	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline; Day 30
Change From Baseline in Systolic and Diastolic BP at Day 60	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline; Day 60
Change From Baseline in Systolic and Diastolic BP at Day 90	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline; Day 90
Change From Baseline in Systolic and Diastolic BP at Day 120	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline; Day 120
Respiratory Rate at Baseline	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline (Day 1)
Change From Baseline in Respiratory Rate at Day 7	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline; Day 7
Change From Baseline in Respiratory Rate at Day 14	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline; Day 14
Change From Baseline in Respiratory Rate at Day 30	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline; Day 30
Change From Baseline in Respiratory Rate at Day 60	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline; Day 60
Change From Baseline in Respiratory Rate at Day 90	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline; Day 90
Change From Baseline in Respiratory Rate at Day 120	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline; Day 120

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With at Least a 1-Grade Improvement at Day 14 as Rated by Participant Using the Participant Allergan Platysma Prominence Scale (P-APPS)	The participants evaluated their own Platysma Prominence severity using a 5-grade scale where 1= minimal, and 5= extreme. Higher values indicate worsening conditions. Data is reported for participants who achieved at least a 1-grade improvement rated on the P-APPS. Percentages are rounded off to whole number at the nearest decimal. CMH chi-squared test was used for analysis.	Day 14

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): April 16, 2020
• Study Completion (Actual): April 16, 2020

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• 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; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 1936-201-008

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