A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
NCT ID: NCT05134649
Last Updated: 2024-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
292 participants
INTERVENTIONAL
2021-11-16
2023-08-18
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BOTOX
BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle for up to 3 Cycles during study M21-323
OnabotulinumtoxinA
Intramuscular Injection
Interventions
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OnabotulinumtoxinA
Intramuscular Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ALLERGAN INC.
Role: STUDY_DIRECTOR
Allergan
Locations
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Advanced Research Associates - Glendale /ID# 231997
Glendale, Arizona, United States
Clear Dermatology & Aesthetics Center /ID# 231990
Scottsdale, Arizona, United States
Clinical Testing of Beverly Hills /ID# 231986
Encino, California, United States
Steve Yoelin MD Medical Assoc. Inc /ID# 232004
Newport Beach, California, United States
Cosmetic Laser Dermatology /ID# 232414
San Diego, California, United States
Ava T. Shamban MD - Santa Monica. /ID# 232000
Santa Monica, California, United States
Art of Skin MD /ID# 231995
Solana Beach, California, United States
DMR Research PLLC /ID# 231998
Westport, Connecticut, United States
Susan H. Weinkle MD /ID# 232001
Bradenton, Florida, United States
Research Institute of the Southeast, LLC /ID# 231974
West Palm Beach, Florida, United States
Laser and Skin Surgery Center of Indiana /ID# 231983
Indianapolis, Indiana, United States
Coleman Center For Cosmetic Dermatologic Surgery /ID# 231977
Metairie, Louisiana, United States
Delricht Research /ID# 231985
New Orleans, Louisiana, United States
Aesthetic Center at Woodholme /ID# 231996
Baltimore, Maryland, United States
Maryland Dermatology Laser, Skin, & Vein Institute /ID# 232002
Hunt Valley, Maryland, United States
Image Dermatology, P.C. /ID# 231980
Montclair, New Jersey, United States
Laser & Skin Surgery Center of New York /ID# 231982
New York, New York, United States
Aesthetic Solutions /ID# 231978
Chapel Hill, North Carolina, United States
Wilmington Dermatology Center /ID# 231981
Wilmington, North Carolina, United States
Aventiv Research Dublin /ID# 231994
Dublin, Ohio, United States
KGL Skin Study Center, LLC /ID# 231993
Newtown Square, Pennsylvania, United States
Nashville Center for Laser and Facial Surgery /ID# 231975
Nashville, Tennessee, United States
Dallas Plastic Surgery Institute /ID# 231999
Dallas, Texas, United States
SkinDC /ID# 231989
Arlington, Virginia, United States
Premier Clinical Research /ID# 232003
Spokane, Washington, United States
Humphrey Cosmetic Dermatology /ID# 239649
Vancouver, British Columbia, Canada
Dermetics Cosmetic Dermatology /ID# 239650
Burlington, Ontario, Canada
Dr Melinda Gooderham Medicine Profession /ID# 239647
Cobourg, Ontario, Canada
The Center For Dermatology /ID# 239651
Richmond Hill, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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M21-323
Identifier Type: -
Identifier Source: org_study_id