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ACTIVE_NOT_RECRUITINGPHASE2

A Study to Evaluate AI-09 In Participants With Glabellar Lines

A Phase 2, Randomized, Double-blind, Vehicle-Controlled, Multi-Center Clinical Trial Study to Evaluate Ready to Use Injectable AI-09 In Participants With Glabellar Lines

NCT07321834•Eirion Therapeutics Inc.

View on ClinicalTrials.gov

Summary

Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin.

Detailed Description

This is a Phase 2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled, multi-center clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin, administered to participants with glabellar lines. The study is designed as a single dose study evaluating AI-09 at a dose of versus Vehicle.

Eligibility

Age

20 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•20 to 70 years of age
•moderate to severe glabellar lines (IGA 2 to 3) at maximum frown
•moderate to severe glabellar lines (SSA 2 to 3) at maximum frown
•willingness to refrain from the use of facial fillers, retinoids, Botox®, laser
•female participants of child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline (Day 0) visit and must utilize birth control throughout the study
•participants should be in good general health as determined by the investigator and free of any disease that may interfere with study evaluations or the Investigational Product

Exclusion Criteria

•the inability to substantially lessen glabellar lines by physically spreading them apart
•eyelid ptosis, and/ or excessive weakness or atrophy in the target muscle(s)
•presence or history of "dry eye"
•history of periocular surgery, brow lift or related procedures, or deep dermal scarring
•concurrent or recent (within the last 6 months) use of any other botulinum toxin drug product anywhere in the body
•history of immunization or hypersensitivity to any botulinum toxin serotype
•history of non-response to any prior botulinum toxin treatments anticipated need for treatment with botulinum toxin of any serotype for any reason during the trial (other than the investigational treatment)
•any medical condition that may put the subject at increased risk with exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
•pregnancy or lactation
•application of any topical prescription medication to the treatment area within 14 days prior to treatment
+3 more criteria

Locations (5)

Center for Clinical and Cosmetic Research

Aventura, Florida, United States

Research Institute of the Southeast, Inc.

West Palm Beach, Florida, United States

Delricht Research

New Orleans, Louisiana, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Research Your Health

Plano, Texas, United States

Key Dates

Start Date

December 3, 2025

Primary Completion Date

February 1, 2026

Completion Date

February 1, 2026

Last Updated

January 7, 2026

Enrollment

ACTUAL participants

Conditions

Glabellar Lines

Interventions

AI-09 Ready Use Injectable Botulinum Toxin

BIOLOGICAL

Vehicle

BIOLOGICAL

A Study to Investigate the Safety and Efficacy of YY003 in Adults with Moderate to Severe Glabellar Lines

NCT06481475

Moderate to Severe Glabellar Lines

View study

ACTIVE_NOT_RECRUITINGPHASE3

A Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines

NCT06583486

Moderate to Severe Glabellar Lines

View study

COMPLETEDPHASE2

Clinical Trial to Evaluate the Safety and Efficacy of JTM201 to Treat Moderate or Severe Glabellar Lines

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate AI-09 In Participants With Glabellar Lines

Inclusion Criteria

Exclusion Criteria

A Study to Investigate the Safety and Efficacy of YY003 in Adults with Moderate to Severe Glabellar Lines

A Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines

Clinical Trial to Evaluate the Safety and Efficacy of JTM201 to Treat Moderate or Severe Glabellar Lines

Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin

Study of AGN-151586 in Japanese Participants With Moderate to Severe Glabellar Lines

AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines