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Neurotoxin
OnabotulinumtoxinA X Dose A for Forehead Wrinkles
Phase 2
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 180
Summary
This trial is testing a new treatment called OnabotulinumtoxinA X for adults with moderate to severe forehead lines. The treatment works by reducing muscle activity that causes these lines. The study will check the safety and effectiveness of different doses of this treatment. OnabotulinumtoxinA has been approved for the treatment of glabellar and crow's feet lines and, most recently, for forehead lines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 180
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Adverse Events
Percentage of Participants with Achievement of ≥ 1-grade improvement from baseline on the investigator-rated clinician forehead lines Scale at maximum contraction.
Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: OnabotulinumtoxinA X Dose CExperimental Treatment1 Intervention
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
Group II: OnabotulinumtoxinA X Dose BExperimental Treatment1 Intervention
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
Group III: OnabotulinumtoxinA X Dose AExperimental Treatment1 Intervention
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo will be injected into the forehead on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OnabotulinumtoxinA X
2021
Completed Phase 2
~460
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Who is running the clinical trial?
AllerganLead Sponsor
781 Previous Clinical Trials
276,530 Total Patients Enrolled
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
79,420 Total Patients Enrolled
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