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Monoclonal Antibodies

AGN-151586 for Frown Lines

Phase 1
Waitlist Available
Research Sponsored by AbbVie
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 at day 60
Awards & highlights

Study Summary

This trial is assessing whether AGN-151586 is safe and effective when given before BOTOX to people with moderate to severe glabellar lines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 60 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 achieving "none" or "mild" on the Facial Wrinkle Scale (FWS) according to the investigator assessment of Glabellar Lines (GL) severity at maximum frown

Side effects data

From 2020 Phase 2 trial • 198 Patients • NCT04096326
14%
Headache
4%
Facial pain
4%
Nausea
4%
Injection site pain
4%
Vision blurred
4%
Photophobia
4%
Rash
4%
Hypothyroidism
4%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: AGN-151586
Cohort 1: Placebo
Cohort 1: AGN-151586
Cohort 2: Placebo
Cohort 3: Placebo
Cohort 3: AGN-151586
Cohort 4: Placebo
Cohort 4: AGN-151586
Cohort 5: Placebo
Cohort 5: AGN-151586

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo, BOTOXExperimental Treatment2 Interventions
Participants will receive 5 intramuscular injections of placebo in the glabellar complex on Day 1. Eligible participants will receive BOTOX injections and will be followed for up to 4 months.
Group II: AGN-151586, BOTOXExperimental Treatment2 Interventions
Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Eligible participants will receive BOTOX injections and will be followed for up to 4 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
BOTOX
2013
Completed Phase 4
~1200
AGN-151586
2022
Completed Phase 3
~2250

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
500,954 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,788 Total Patients Enrolled

Frequently Asked Questions

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

Has AGN-151586 received clearance from the FDA?

"Our team at Power believes that AGN-151586 is relatively safe as indicated by its score of 1 on a scale from 1 to 3. This rating was assigned due to the limited clinical data available supporting safety and efficacy in Phase 1 trials."

Answered by AI

Is this research project still open to new participants?

"As recorded on clinicaltrials.gov, this study is seeking participants as of now. This medical trial was first advertised on August 30th 2022 and its data was last modified a month later."

Answered by AI

What is the maximum capacity for participation in this medical experiment?

"Affirmative. Clinicaltrials.gov documents state that this trial, originally posted on August 30th 2022, is actively looking for suitable participants. The research seeks 80 volunteers from 10 different medical sites."

Answered by AI

How many healthcare facilities are currently conducting the trial?

"Various sites are providing this trial, including the Premier Clinical Research /ID# 244429 in Spokane and AboutSkin Research, LLC /ID# 244416 in Greenwood Village. Cosmetic Laser Dermatology /ID# 244425 is also assisting with the study from its San Diego facility, accompanied by other 10 centres."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have used Juvederm before by itself and felt it really made very little difference, I am very interested to see if my frown lines could be helped by using a combination of treatments.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

If accepted, when would the trial begin?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines
2022. "A Study to Evaluate Sequential Administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) Injections in Adult Participants for Treatment of Glabellar Lines". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05496335.
~35 spots leftby Apr 2025
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