Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines
NCT ID: NCT03736928
Last Updated: 2022-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
401 participants
INTERVENTIONAL
2018-11-26
2020-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Placebo
Intramuscular single treatment
placebo
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
AbobotulinumtoxinA dose level 1 or 2
Intramuscular single treatment
AbobotulinumtoxinA dose level 1 or 2
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
AbobotulinumtoxinA dose level 3
Intramuscular single treatment
AbobotulinumtoxinA dose 3
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
AbobotulinumtoxinA dose level 4
Intramuscular single treatment
AbobotulinumtoxinA dose 4
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Interventions
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AbobotulinumtoxinA dose level 1 or 2
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
placebo
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
AbobotulinumtoxinA dose 3
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
AbobotulinumtoxinA dose 4
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Galderma Research Site
Encino, California, United States
Galderma Research Site
Manhattan Beach, California, United States
Galderma Research Site
Vista, California, United States
Galderma Research Site
Coral Gables, Florida, United States
Galderma Research Site
Chicago, Illinois, United States
Galderma Research Site
New Orleans, Louisiana, United States
Galderma Research Site
New York, New York, United States
Galderma Research Site
Chapel Hill, North Carolina, United States
Galderma Research Site
Charlotte, North Carolina, United States
Galderma Research Site
Mequon, Wisconsin, 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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43USD1801
Identifier Type: -
Identifier Source: org_study_id
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