Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
NCT ID: NCT03014622
Last Updated: 2022-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
303 participants
INTERVENTIONAL
2016-12-08
2017-11-14
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
TRIPLE
Study Groups
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DaxibotulinumtoxinA 40 units
Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A
Intramuscular injection
Placebo
Biological/Vaccine: Placebos Intramuscular injection
Placebos
Intramuscular injection
Interventions
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Botulinum Toxins, Type A
Intramuscular injection
Placebos
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
75 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
Newport Beach, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Greenwood, Colorado, United States
Boca Raton, Florida, United States
Coral Gables, Florida, United States
Chestnut Hill, Massachusetts, United States
Birmingham, Michigan, United States
Montclair, New Jersey, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Nashville, Tennessee, United States
Countries
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References
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Bertucci V, Solish N, Kaufman-Janette J, Yoelin S, Shamban A, Schlessinger J, Snyder D, Gallagher C, Liu Y, Shears G, Rubio RG. DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). J Am Acad Dermatol. 2020 Apr;82(4):838-845. doi: 10.1016/j.jaad.2019.06.1313. Epub 2019 Nov 29.
Carruthers JD, Fagien S, Joseph JH, Humphrey SD, Biesman BS, Gallagher CJ, Liu Y, Rubio RG; SAKURA 1 and SAKURA 2 Investigator Group; SAKURA 1 and SAKURA 2 Investigator Group includes the following. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2). Plast Reconstr Surg. 2020 Jan;145(1):45-58. doi: 10.1097/PRS.0000000000006327.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1620301
Identifier Type: -
Identifier Source: org_study_id
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