Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
NCT ID: NCT03911102
Last Updated: 2023-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2019-03-11
2020-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1: DAXI 12 U
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
DaxibotulinumtoxinA for injection
Intramuscular injection
Cohort 2: DAXI 24 U
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
DaxibotulinumtoxinA for injection
Intramuscular injection
Cohort 3: DAXI 36 U
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
DaxibotulinumtoxinA for injection
Intramuscular injection
Cohort 4: DAXI 48 U
DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
DaxibotulinumtoxinA for injection
Intramuscular injection
Interventions
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DaxibotulinumtoxinA for injection
Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* Be outpatient, male or female subjects, in good general health, 18-65 years old
* Have a score of moderate (2) or severe (3) LCL at maximum smile effort as assessed by the IGA-LCWS
* Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Exclusion Criteria
* History of clinically significant bleeding disorders
* Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study, as determined by the investigator
* Planned or anticipated need for surgery or hospitalization through the end of the study
* Pregnant, nursing, or planning a pregnancy during the study; or is Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception
* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening through the end of the study
18 Years
65 Years
ALL
No
Sponsors
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Revance Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Sacramento, CA Site
Sacramento, California, United States
Sarasota, FL Site
Sarasota, Florida, United States
Itasca, IL Site
Itasca, Illinois, United States
Arlington, VA Site
Arlington, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1820205
Identifier Type: -
Identifier Source: org_study_id
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