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

January 5, 2026 updated by: Eirion Therapeutics Inc.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Aventura, Florida, United States, 33180
        • Center for Clinical and Cosmetic Research
      • West Palm Beach, Florida, United States, 33401
        • Research Institute of the Southeast, Inc.
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
    • Texas
      • Plano, Texas, United States, 75093
        • Research Your Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline (Day 0)
  • alcohol or drug abuse within the past 3 years
  • refusal or inability with the subject's ability to give informed consent or comply with the requirements of the protocol for any reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Biological: Vehicle
Vehicle
Experimental: Active Treatment
AI-09
Biological: AI-09 Ready Use Injectable Botulinum Toxin
AI-09 Ready Use Injectable Botulinum Toxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IGA-C
Time Frame: From enrollment (baseline) to the Week 04 Visit
Change from Baseline (CfB) in IGA-C (Investigator Global Assessment on Contraction) as assessed using the 4-point Glabellar Line Severity Scale (GLS), with score "3" being Severe and score "0" being None.
From enrollment (baseline) to the Week 04 Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eirion Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AI-09-GL-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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