A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
NCT ID: NCT04994535
Last Updated: 2024-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
426 participants
INTERVENTIONAL
2021-08-10
2023-06-14
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 across approximately 35 sites in USA, Belgium, Canada, Germany and the UK.
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) will be 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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Total Skin and Beauty Derm Ctr /ID# 249905
Birmingham, Alabama, United States
Westside Aesthetics /ID# 231196
Los Angeles, California, United States
Skin Care and Laser Physicians of Beverly Hills /ID# 231194
Los Angeles, California, United States
Moradi MD /ID# 244719
Vista, California, United States
Skin Research Institute LLC /ID# 231195
Coral Gables, Florida, United States
Skin and Cancer Associates, LLP /ID# 231189
Miami, Florida, United States
DeNova Research /ID# 231191
Chicago, Illinois, United States
Oak Dermatology in Naperville /ID# 231193
Naperville, Illinois, United States
Etre Cosmetic Dermatology and Laser Center /ID# 231192
New Orleans, Louisiana, United States
BOYD Beauty Birmingham /ID# 231190
Birmingham, Michigan, United States
Michigan Center for Research Corporation /ID# 249911
Clinton Township, Michigan, United States
Skin Specialists, PC /ID# 249903
Omaha, Nebraska, United States
The Center for Dermatology Cosmetics & Laser Surgery /ID# 231187
Mount Kisco, New York, United States
Luxurgery /ID# 244924
New York, New York, United States
Coastal Clinical Research Center of the Carolinas /ID# 231197
Charleston, South Carolina, United States
Tennessee Clinical Research Center /ID# 244720
Nashville, Tennessee, United States
DermResearch, Inc. Austin, TX /ID# 249904
Austin, Texas, United States
Bellaire Dermatology Associates /ID# 249902
Bellaire, Texas, United States
Austin Institute for Clinical Research at SBA Dermatology /ID# 232104
Houston, Texas, United States
Austin Institute for Clinical Research /ID# 244936
Pflugerville, Texas, United States
UZ Brussel /ID# 229125
Jette, Brussels Capital, Belgium
Medical Skincare /ID# 229129
Sint-Truiden, Limburg, Belgium
Duinbergen Clinic /ID# 231282
Knokke-Heist, West-Vlaanderen, Belgium
Beacon Dermatology Inc /ID# 231675
Calgary, Alberta, Canada
Pacific Derm /ID# 231019
Vancouver, British Columbia, Canada
Sweat Clinics of Canada /ID# 231021
Toronto, Ontario, Canada
Bertucci MedSpa Inc. /ID# 231020
Woodbridge, Ontario, Canada
Studienzentrum Theatiner46 /ID# 229570
Munich, Bavaria, Germany
Rosenpark Research /ID# 229568
Darmstadt, Hesse, Germany
Noahklinik GmbH /ID# 232311
Kassel, , Germany
Hautok and Hautok-cosmetics /ID# 229573
München, , Germany
Privatpraxis fuer Dermatologie und Aesthetik /ID# 230901
München, , Germany
Waverley Medical Practice /ID# 229590
Coatbridge, , United Kingdom
MediZen Premier Aesthetic Clinic /ID# 229588
Sutton Coldfield, , United Kingdom
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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2021-000240-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M21-310
Identifier Type: -
Identifier Source: org_study_id
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