Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines
NCT ID: NCT03004248
Last Updated: 2022-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2691 participants
INTERVENTIONAL
2016-12-09
2018-10-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DaxibotulinumtoxinA 40 units
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A
Intramuscular Injection
Interventions
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Botulinum Toxins, Type A
Intramuscular Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale
* Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial
Exclusion Criteria
* Active skin disease, infections or inflammation at the injection sites
* Plan to receive botulinum toxin type A anywhere in the face through the duration of the study
* History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article
* Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial
18 Years
ALL
No
Sponsors
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Revance Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Beverly Hills, California, United States
Encinitas, California, United States
Fremont, California, United States
Los Angeles, California, United States
Manhattan Beach, California, United States
Newport Beach, California, United States
Roseville, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Greenwood Village, Colorado, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Bradenton, Florida, United States
Coral Gables, Florida, United States
Miami, Florida, United States
West Palm Beach, Florida, United States
Chicago, Illinois, United States
Lincolnshire, Illinois, United States
Naperville, Illinois, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Glenn Dale, Maryland, United States
Hunt Valley, Maryland, United States
Rockville, Maryland, United States
Chestnut Hill, Massachusetts, United States
Birmingham, Michigan, United States
Fridley, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Montclair, New Jersey, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
West Islip, New York, United States
White Plains, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
High Point, North Carolina, United States
Portland, Oregon, United States
Drexel Hill, Pennsylvania, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
College Station, Texas, United States
Houston, Texas, United States
Katy, Texas, United States
Mequon, Wisconsin, United States
Vancouver, British Columbia, Canada
Burlington, Ontario, Canada
Toronto, Ontario, Canada
Woodbridge, Ontario, Canada
Montreal, Quebec, Canada
Countries
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References
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Green JB, Mariwalla K, Coleman K, Ablon G, Weinkle SH, Gallagher CJ, Vitarella D, Rubio RG. A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study. Dermatol Surg. 2021 Jan 1;47(1):42-46. doi: 10.1097/DSS.0000000000002463.
Fabi SG, Cohen JL, Green LJ, Dhawan S, Kontis TC, Baumann L, Gross TM, Gallagher CJ, Brown J, Rubio RG. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study. Dermatol Surg. 2021 Jan 1;47(1):48-54. doi: 10.1097/DSS.0000000000002531.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1620303
Identifier Type: -
Identifier Source: org_study_id
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