NCT07321834

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 2, 2026

Last Update Submit

January 5, 2026

Conditions

Glabellar Lines

Keywords

Botulinum ToxinReady to useGlabellar LinesAI-09-GL-201

Outcome Measures

Primary Outcomes (1)

  • IGA-C

    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

Study Arms (2)

Active Treatment

EXPERIMENTAL

AI-09

Biological: AI-09 Ready Use Injectable Botulinum Toxin

Vehicle

PLACEBO COMPARATOR

Vehicle

Biological: Vehicle

Interventions

AI-09 Ready Use Injectable Botulinum ToxinBIOLOGICAL

AI-09 Ready Use Injectable Botulinum Toxin

Active Treatment
VehicleBIOLOGICAL

Vehicle

Vehicle

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Research Institute of the Southeast, Inc.

West Palm Beach, Florida, 33401, United States

Location

Delricht Research

New Orleans, Louisiana, 70115, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 7, 2026

Study Start

December 3, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(5)