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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
Awards & highlights

Study Summary

Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. OnabotulinumtoxinA X is being investigated as another form of treatment to treat FHL by inhibiting the release of the neurotransmitter that causes the overactivity of the muscles responsible for the severity of these facial lines. The purpose of this study is to evaluate the safety and change in condition of 3 doses of OnabotulinumtoxinA X for the treatment of moderate to severe forehead lines. Study doctors will determine if a subject is eligible for the study. If so, the subject will be randomized into 1 of the 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 120 adult participants with FHL will be enrolled in the study in approximately 10 sites in the United States. Participants will receive either intramuscular injections of onabotulinumtoxinA X or placebo. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,445 Total Patients Enrolled
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
79,135 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
North Carolina
Other
California
Texas
How old are they?
18 - 65
What site did they apply to?
The Eye Research Foundation /ID# 241512
Steve Yoelin MD Medical Assoc. Inc /ID# 239771
Austin Institute for Clinical Research /ID# 239783
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~37 spots leftby Apr 2025