Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
171 participants
INTERVENTIONAL
2019-04-23
2020-04-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
Placebo
Placebo injections.
BOTOX® Low Dose
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
BOTOX® purified neurotoxin complex
BOTOX® superficial intramuscular injections.
BOTOX® High Dose
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
BOTOX® purified neurotoxin complex
BOTOX® superficial intramuscular injections.
Interventions
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BOTOX® purified neurotoxin complex
BOTOX® superficial intramuscular injections.
Placebo
Placebo injections.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies:
1. Not a woman of childbearing potential (WOCBP) OR
2. A WOCBP who agrees to follow the studies contraceptive guidance during the treatment and follow-up period through study exit.
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this study's protocol
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
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
* Females who are pregnant, nursing, or planning a pregnancy during the study
* Known immunization or hypersensitivity to any botulinum toxin serotype
* History of alcohol or drug abuse within 12 months of the study
* Participant has tattoos, jewelry, or clothing that cannot be removed, and that obscure the neck
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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ALLERGAN INC.
Role: STUDY_DIRECTOR
Allergan
Locations
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Skin Care and Laser Physicians of Beverly Hills /ID# 236518
Los Angeles, California, United States
Skin Research Institute LLC /ID# 238126
Coral Gables, Florida, United States
DeNova Research /ID# 238165
Chicago, Illinois, United States
MD Laser Skin & Vein /ID# 234532
Hunt Valley, Maryland, United States
The Center for Dermatology Cosmetics & Laser Surgery /ID# 235624
Mount Kisco, New York, United States
The Practice of Brian S. Biesman MD PLLC /ID# 234461
Nashville, Tennessee, United States
Dallas Plastic Surgery Institute /ID# 236528
Dallas, Texas, United States
Humphrey Cosmetic Dermatology /ID# 236591
Vancouver, British Columbia, Canada
Pacific Derm /ID# 238236
Vancouver, British Columbia, Canada
Dermetics Cosmetic Dermatology /ID# 236899
Burlington, Ontario, Canada
Sweat Clinics of Canada /ID# 236590
Toronto, Ontario, Canada
Bertucci MedSpa Inc. /ID# 236523
Woodbridge, Ontario, Canada
Countries
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References
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Garcia JK, Hopfinger RM, Foley C, Whyte J, Gauthier M, Foster B, Patel V. Development and validation of patient-reported outcome measures for platysma prominence. Curr Med Res Opin. 2025 Jul;41(7):1277-1290. doi: 10.1080/03007995.2025.2537898. Epub 2025 Jul 31.
Rohrich RJ, Bertucci V, Dayan S, Jones D, Solish N, Rivers JK, Weiss RA, Muhn CY, Harutunian C, Park GS, Shimoga S, Lee E, Tong W. Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Platysma Prominence: A Randomized Phase 2 Dose-Ranging Study. Plast Reconstr Surg. 2025 Jan 1;155(1):79-88. doi: 10.1097/PRS.0000000000011472. Epub 2024 Apr 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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1936-201-008
Identifier Type: -
Identifier Source: org_study_id
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