A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence

Phase 3, Multicenter Open-label Extension Study to Evaluate the Safety of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence

This is a Phase 3, open-label extension study to evaluate the long-term safety of repeat BOTOX treatments in adult participants with Platysma Prominence. Participants who completed the lead-in Phase 3 Study M21-309 and met eligibility requirements could enroll in this open-label extension study.

Planned study enrollment was approximately 270 participants. Participants who met treatment criteria could receive up to 3 administrations of BOTOX. Day 1 (study entry) was the same day as Day 120/study exit visit of the lead-in Phase 3 study. The first administration of study drug could occur at the Day 1 visit, and the last administration of study drug could occur at the Day 180 visit (60 days prior to Day 240/study exit). Once a subject was enrolled in this study, monthly follow-up visits occurred.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Humphrey Cosmetic Dermatology /ID# 239649
  • Ontario
    • Burlington, Ontario, Canada, L7N 3N2
      • Dermetics Cosmetic Dermatology /ID# 239650
    • Cobourg, Ontario, Canada, K9A 0Z4
      • Dr Melinda Gooderham Medicine Profession /ID# 239647
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Center For Dermatology /ID# 239651
• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Advanced Research Associates - Glendale /ID# 231997
    • Scottsdale, Arizona, United States, 85255-4134
      • Clear Dermatology & Aesthetics Center /ID# 231990
  • California
    • Encino, California, United States, 91436-2124
      • Clinical Testing of Beverly Hills /ID# 231986
    • Newport Beach, California, United States, 92663-3311
      • Steve Yoelin MD Medical Assoc. Inc /ID# 232004
    • San Diego, California, United States, 92121-2119
      • Cosmetic Laser Dermatology /ID# 232414
    • Santa Monica, California, United States, 90404-2208
      • Ava T. Shamban MD - Santa Monica. /ID# 232000
    • Solana Beach, California, United States, 92075-2228
      • Art of Skin MD /ID# 231995
  • Connecticut
    • Westport, Connecticut, United States, 06880-5369
      • DMR Research PLLC /ID# 231998
  • Florida
    • Bradenton, Florida, United States, 34209-5642
      • Susan H. Weinkle MD /ID# 232001
    • West Palm Beach, Florida, United States, 33401-2712
      • Research Institute of the Southeast, LLC /ID# 231974
  • Indiana
    • Indianapolis, Indiana, United States, 46260-2386
      • Laser and Skin Surgery Center of Indiana /ID# 231983
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Coleman Center For Cosmetic Dermatologic Surgery /ID# 231977
    • New Orleans, Louisiana, United States, 70115
      • Delricht Research /ID# 231985
  • Maryland
    • Baltimore, Maryland, United States, 21208-6391
      • Aesthetic Center at Woodholme /ID# 231996
    • Hunt Valley, Maryland, United States, 21030-3216
      • Maryland Dermatology Laser, Skin, & Vein Institute /ID# 232002
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • Image Dermatology, P.C. /ID# 231980
  • New York
    • New York, New York, United States, 10016-4974
      • Laser & Skin Surgery Center of New York /ID# 231982
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517-9901
      • Aesthetic Solutions /ID# 231978
    • Wilmington, North Carolina, United States, 28403
      • Wilmington Dermatology Center /ID# 231981
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Aventiv Research Dublin /ID# 231994
  • Pennsylvania
    • Newtown Square, Pennsylvania, United States, 19073-2228
      • KGL Skin Study Center, LLC /ID# 231993
  • Tennessee
    • Nashville, Tennessee, United States, 37203-1513
      • Nashville Center for Laser and Facial Surgery /ID# 231975
  • Texas
    • Dallas, Texas, United States, 75231
      • Dallas Plastic Surgery Institute /ID# 231999
  • Virginia
    • Arlington, Virginia, United States, 22209
      • SkinDC /ID# 231989
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research /ID# 232003

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

- Completion of all phases of the lead-in Phase 3 study (Screening Period, Treatment Period [randomization/treatment with 4-month follow-up visit] and Study Exit visit)

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
• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BOTOX; BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle for up to 3 Cycles during study M21-323	Drug: OnabotulinumtoxinA; Intramuscular 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 casual relationship with this treatment.	371 days (from enrollment in the lead-in study M21-309 through end of study M21-323)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): August 18, 2023
• Study Completion (Actual): August 18, 2023

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: November 8, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: OnabotulinumtoxinA; BOTOX; Platysma Prominence
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Neuromuscular Agents; Acetylcholine Release Inhibitors; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: M21-323

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