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Neurotoxin

AGN-151586 for Frown Lines

Phase 3
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be able to accurately assess their facial lines without the use of eyeglasses (contact lens use is acceptable).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hour 24
Awards & highlights

Study Summary

This trial is testing a new product, AGN-151586, to see if it is safe and effective in treating moderate to severe glabellar lines (frown lines). The study is double-blind, meaning that neither the participant nor the researcher will know who is receiving AGN-151586 or Placebo. The study will last for 12 weeks, and participants will be given 5 intramuscular injections on the first day. Participants may be eligible for open-label treatment during the study if they meet certain criteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You must be able to see your facial lines clearly without wearing glasses (you can wear contact lenses).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hour 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and hour 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in ECG parameters
Change from baseline in Vital Sign Measurements
Change from baseline in laboratory evaluations
+3 more
Secondary outcome measures
Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the FLSQ Item 4 (natural look) for GL
Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the FLSQ Item 5 (overall satisfaction) for GL
Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Item 5 (overall satisfaction) for GL
+2 more

Side effects data

From 2020 Phase 2 trial • 198 Patients • NCT04096326
26%
Injection site pain
7%
Dysgeusia
4%
Nausea
4%
Headache
4%
Dizziness
4%
Paronychia
4%
Urinary tract infection
4%
Urticaria
4%
Muscle strain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 3: AGN-151586
Cohort 2: AGN-151586
Cohort 1: AGN-151586
Cohort 1: Placebo
Cohort 5: Placebo
Cohort 2: Placebo
Cohort 3: Placebo
Cohort 4: Placebo
Cohort 4: AGN-151586
Cohort 5: AGN-151586

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AGN-151586Experimental Treatment1 Intervention
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
Group II: PlaceboPlacebo Group2 Interventions
Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AGN-151586
2022
Completed Phase 3
~2230

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
275,155 Total Patients Enrolled
1 Trials studying Frown Lines
101 Patients Enrolled for Frown Lines
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
77,845 Total Patients Enrolled

Frequently Asked Questions

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

How many test subjects are included in this clinical trial?

"600 participants that match the study's prerequisites are necessary to complete the trial. The sponsor, Allergan, will be running the show from different sites including KGL Skin Study Center, LLC /ID# 233549 in Newtown Square, Pennsylvania and Total Skin and Beauty Derm Ctr /ID# 232378 in Birmingham, Alabama."

Answered by AI

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

"Presently, this clinical trial is recruiting patients from 22 different sites. The locations are situated in Newtown Square, Birmingham and Encino as well as other cities. To limit travel requirements, please select the location nearest you."

Answered by AI

Are new participants being welcomed into this clinical trial?

"Yes, this clinical trial is looking for participants and has been since it was originally posted on March 4th, 2022. According to the website, the last update to the trials information was on October 24th, 2022."

Answered by AI

What are the potential risks associated with AGN-151586?

"AGN-151586 has received a 3 for safety. This is due to the fact that it is a Phase 3 trial, which suggests that not only does this drug have some evidence of efficacy, but there are also multiple rounds of data supporting its safety."

Answered by AI

What are the goals researchers hope to achieve with this clinical trial?

"The primary outcome of this study is the number of participants with adverse events, which will be measured over a period of 7 days. Secondary outcomes include the percentage of participants who are mostly or very satisfied with the treatment according to the Facial Line Satisfaction Questionnaire (FLSQ), the percentage of participants who show a 2-grade improvement in facial wrinkles from baseline, and the percentage of participants who are mostly or very satisfied with the natural look of their skin after treatment."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
What site did they apply to?
The Research Center at The Maas Clinic /ID# 241262
Austin Institute for Clinical Research at SBA Dermatology /ID# 232316
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0

Why did patients apply to this trial?

i work in the customer services and music industry.
PatientReceived 1 prior treatment
~213 spots leftby Mar 2025