A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence
NCT ID: NCT04949399
Last Updated: 2024-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
408 participants
INTERVENTIONAL
2021-07-08
2022-12-20
Brief Summary
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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 in the United States and Canada.
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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BOTOX
BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1
OnabotulinumtoxinA
Injection
Placebo
Placebo will be injected into the platysma muscle on Day 1
Placebo
Saline Injection
Interventions
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OnabotulinumtoxinA
Injection
Placebo
Saline Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Advanced Research Associates - Glendale /ID# 229256
Glendale, Arizona, United States
Clear Dermatology & Aesthetics Center /ID# 229252
Scottsdale, Arizona, United States
Clinical Testing of Beverly Hills /ID# 229946
Encino, California, United States
Dermatology Research Associates /ID# 229949
Los Angeles, California, United States
Steve Yoelin MD Medical Associate Inc /ID# 229420
Newport Beach, California, United States
Cosmetic Laser Dermatology /ID# 229245
San Diego, California, United States
Ava T. Shamban MD - Santa Monica. /ID# 229421
Santa Monica, California, United States
Art of Skin MD /ID# 229255
Solana Beach, California, United States
DMR Research PLLC /ID# 229938
Westport, Connecticut, United States
Susan H. Weinkle MD /ID# 229419
Bradenton, Florida, United States
Research Institute of the Southeast, LLC /ID# 229234
West Palm Beach, Florida, United States
Laser and Skin Surgery Center of Indiana /ID# 229515
Indianapolis, Indiana, United States
Coleman Center For Cosmetic Dermatologic Surgery /ID# 229414
Metairie, Louisiana, United States
Delricht Research /ID# 229248
New Orleans, Louisiana, United States
Aesthetic Center at Woodholme /ID# 229836
Baltimore, Maryland, United States
Maryland Dermatology Laser, Skin, & Vein Institute /ID# 229260
Hunt Valley, Maryland, United States
Image Dermatology, P.C. /ID# 229244
Montclair, New Jersey, United States
Laser & Skin Surgery Center of New York /ID# 229423
New York, New York, United States
Aesthetic Solutions /ID# 229241
Chapel Hill, North Carolina, United States
Wilmington Dermatology Center /ID# 229246
Wilmington, North Carolina, United States
Aventiv Research Dublin /ID# 229254
Dublin, Ohio, United States
KGL Skin Study Center, LLC /ID# 229253
Newtown Square, Pennsylvania, United States
Nashville Center for Laser and Facial Surgery /ID# 229237
Nashville, Tennessee, United States
Dallas Plastic Surgery Institute /ID# 229258
Dallas, Texas, United States
SkinDC /ID# 229251
Arlington, Virginia, United States
Premier Clinical Research /ID# 229261
Spokane, Washington, United States
Humphrey Cosmetic Dermatology /ID# 229522
Vancouver, British Columbia, Canada
Dermetics Cosmetic Dermatology /ID# 229482
Burlington, Ontario, Canada
Dr Melinda Gooderham Medicine Profession /ID# 229456
Cobourg, Ontario, Canada
The Center For Dermatology /ID# 229481
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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Other Identifiers
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M21-309
Identifier Type: -
Identifier Source: org_study_id
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