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Neurotoxin

OnabotulinumtoxinA X for Frown Lines

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 270
Awards & highlights

Study Summary

This trial is testing a new botox-like drug to see if it is safe and effective for treating wrinkles between the eyebrows.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 270
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 270 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Adverse Events (AEs)
Percentage of Participants with Achievement of ≥ 1-grade improvement from baseline as rated by investigator using the Clinician Glabellar Lines Scale.
Secondary outcome measures
Percentage of Participants with Achievement of None or Mild as rated by investigator using the Clinician Glabellar Lines Scale.
Percentage of Participants with Achievement of improvement per the Facial Lines Satisfaction Questionnaire Impact domain, among subjects with baseline scores of 14 points or greater.
Percentage of Participants with Achievement of satisfaction with treatment per the Facial Line Satisfaction Questionnaire Item 5.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: OnabotulinumtoxinA X Dose CExperimental Treatment1 Intervention
OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1.
Group II: OnabotulinumtoxinA X Dose BExperimental Treatment1 Intervention
OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1.
Group III: OnabotulinumtoxinA X Dose AExperimental Treatment1 Intervention
OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo will be injected into the Glabellar Complex 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
276,241 Total Patients Enrolled
1 Trials studying Frown Lines
101 Patients Enrolled for Frown Lines
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
78,931 Total Patients Enrolled

Frequently Asked Questions

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

Are there any previous instances of research on OnabotulinumtoxinA X?

"The initial clinical trials for OnabotulinumtoxinA X occurred in 2012 at Rothman Institute. As of now, there have been a total of 18674 completed studies. At the moment, there are 68 active trials taking place; many within Wilmington, North carolina."

Answered by AI

How many people are being treated with this new medication in total?

"Patients are not being recruited for this study at the moment. This trial was first posted on October 6th, 2021 and was last edited on April 18th, 2022. If you're looking for other trials, there are currently 6 studies actively recruiting patients with glabellar lines and 68 studies for OnabotulinumtoxinA X admitting participants."

Answered by AI

Does OnabotulinumtoxinA X have FDA approval for therapeutic use?

"While Phase 2 trials have not yet yielded data supporting efficacy, there is some evidence to suggest OnabotulinumtoxinA X is safe."

Answered by AI

In how many different hospitals is this medical study being run today?

"There are a total of 18 clinical trial sites conducting this research. Some examples of locations include Wilmington, Austin and Glendale. If you want to participate in the trial, selecting a clinic nearest to you will minimize travel requirements."

Answered by AI

For what purpose is OnabotulinumtoxinA X most frequently employed?

"OnabotulinumtoxinA X has a versatile medical applications; it is commonly used to treat urinary incontinence but can also be given for conditions such as spinal cord injury, overactive bladder syndrome (OAB), etc."

Answered by AI

Are there any available vacancies in this study for new participants?

"As of right now, this study has completed participant recruitment. The study was first posted on October 6th, 2021 and was edited as recently as April 18th, 2022. For individuals still interested in participating in clinical trials, there are currently 6 other glabellar lines studies and 68 OnabotulinumtoxinA X trials enrolling patients."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New York
Florida
How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Research Institute of the Southeast, LLC /ID# 230436
Recent research and studies
clinicaltrials.govStudy
A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
2021. "A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05100199.
~94 spots leftby Apr 2025
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