Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines
NCT ID: NCT02303002
Last Updated: 2016-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
268 participants
INTERVENTIONAL
2014-12-31
2016-01-31
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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Dose A
Dose A: Botulinum Toxin Type A
Botulinum Toxin Type A
Intramuscular injection (IM)
Dose B
Dose B: Botulinum Toxin Type A
Botulinum Toxin Type A
Intramuscular injection (IM)
Dose C
Dose C: Botulinum Toxin Type A
Botulinum Toxin Type A
Intramuscular injection (IM)
Dose D
Dose D: Botulinum Toxin Type A
Active Comparator botulinum toxin
IM injection
Dose E
Dose E: Placebo
Placebo Comparator
IM injection
Interventions
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Botulinum Toxin Type A
Intramuscular injection (IM)
Active Comparator botulinum toxin
IM injection
Placebo Comparator
IM injection
Eligibility Criteria
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Inclusion Criteria
* Female or male, 30 to 65 years of age in good general health
* Women of childbearing potential must agree to use an effective method of birth control during the course of the study
* Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response
Exclusion Criteria
* Muscle weakness or paralysis, particularly in the treatment area
* Active skin disease or infections or irritation at the treatment area
* Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart
* Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body
30 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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Vancouver, British Columbia, Canada
Countries
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References
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Bertucci V, Humphrey S, Carruthers J, Solish N, Muhn C, Swift A, Rubio RG, Shears G, Rosen N. Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines: Additional Analyses From a Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Study. Dermatol Surg. 2017 Dec;43 Suppl 3:S262-S273. doi: 10.1097/DSS.0000000000001364.
Carruthers J, Solish N, Humphrey S, Rosen N, Muhn C, Bertucci V, Swift A, Metelitsa A, Rubio RG, Waugh J, Quiring J, Shears G, Carruthers A. Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo. Dermatol Surg. 2017 Nov;43(11):1321-1331. doi: 10.1097/DSS.0000000000001206.
Other Identifiers
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CTA Control No. 179120
Identifier Type: OTHER
Identifier Source: secondary_id
File No. 9427-R1312\1-22C
Identifier Type: OTHER
Identifier Source: secondary_id
RT002-CL002
Identifier Type: -
Identifier Source: org_study_id
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