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
1 other identifier
interventional
292
2 countries
29
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2021
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2021
CompletedStudy Start
First participant enrolled
November 16, 2021
CompletedFirst Posted
Study publicly available on registry
November 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2023
CompletedResults Posted
Study results publicly available
December 5, 2024
CompletedDecember 5, 2024
November 1, 2024
1.8 years
November 15, 2021
November 8, 2024
November 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
BOTOX
EXPERIMENTALBOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle for up to 3 Cycles during study M21-323
Interventions
Eligibility Criteria
You may qualify if:
- \- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (29)
Advanced Research Associates - Glendale /ID# 231997
Glendale, Arizona, 85308, United States
Clear Dermatology & Aesthetics Center /ID# 231990
Scottsdale, Arizona, 85255-4134, United States
Clinical Testing of Beverly Hills /ID# 231986
Encino, California, 91436-2124, United States
Steve Yoelin MD Medical Assoc. Inc /ID# 232004
Newport Beach, California, 92663-3311, United States
Cosmetic Laser Dermatology /ID# 232414
San Diego, California, 92121-2119, United States
Ava T. Shamban MD - Santa Monica. /ID# 232000
Santa Monica, California, 90404-2208, United States
Art of Skin MD /ID# 231995
Solana Beach, California, 92075-2228, United States
DMR Research PLLC /ID# 231998
Westport, Connecticut, 06880-5369, United States
Susan H. Weinkle MD /ID# 232001
Bradenton, Florida, 34209-5642, United States
Research Institute of the Southeast, LLC /ID# 231974
West Palm Beach, Florida, 33401-2712, United States
Laser and Skin Surgery Center of Indiana /ID# 231983
Indianapolis, Indiana, 46260-2386, United States
Coleman Center For Cosmetic Dermatologic Surgery /ID# 231977
Metairie, Louisiana, 70006, United States
Delricht Research /ID# 231985
New Orleans, Louisiana, 70115, United States
Aesthetic Center at Woodholme /ID# 231996
Baltimore, Maryland, 21208-6391, United States
Maryland Dermatology Laser, Skin, & Vein Institute /ID# 232002
Hunt Valley, Maryland, 21030-3216, United States
Image Dermatology, P.C. /ID# 231980
Montclair, New Jersey, 07042, United States
Laser & Skin Surgery Center of New York /ID# 231982
New York, New York, 10016-4974, United States
Aesthetic Solutions /ID# 231978
Chapel Hill, North Carolina, 27517-9901, United States
Wilmington Dermatology Center /ID# 231981
Wilmington, North Carolina, 28403, United States
Aventiv Research Dublin /ID# 231994
Dublin, Ohio, 43016, United States
KGL Skin Study Center, LLC /ID# 231993
Newtown Square, Pennsylvania, 19073-2228, United States
Nashville Center for Laser and Facial Surgery /ID# 231975
Nashville, Tennessee, 37203-1513, United States
Dallas Plastic Surgery Institute /ID# 231999
Dallas, Texas, 75231, United States
SkinDC /ID# 231989
Arlington, Virginia, 22209, United States
Premier Clinical Research /ID# 232003
Spokane, Washington, 99202, United States
Humphrey Cosmetic Dermatology /ID# 239649
Vancouver, British Columbia, V5Z 4E1, Canada
Dermetics Cosmetic Dermatology /ID# 239650
Burlington, Ontario, L7N 3N2, Canada
Dr Melinda Gooderham Medicine Profession /ID# 239647
Cobourg, Ontario, K9A 0Z4, Canada
The Center For Dermatology /ID# 239651
Richmond Hill, Ontario, L4B 1A5, Canada
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ALLERGAN INC.
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2021
First Posted
November 26, 2021
Study Start
November 16, 2021
Primary Completion
August 18, 2023
Study Completion
August 18, 2023
Last Updated
December 5, 2024
Results First Posted
December 5, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- 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/
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.