NCT05565950

Brief Summary

AI-09 In Subjects with Glabellar Lines

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

2 active sites

Status
completed

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

September 3, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2024

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

1.8 years

First QC Date

September 27, 2022

Last Update Submit

August 26, 2025

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

  • Investigators Global Assessment (IGA)

    Investigators Global Assessment. Glabellar Line Severity scale where severity is scored between 0-4 (0=absent; 4=severe).

    18 Weeks (26 Weeks for Cohorts 4, 5 & 6)

Secondary Outcomes (1)

  • Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score

    Week 1, 2, 4, 8, 12, 18 (Week 26 assessments for Cohorts 4, 5 & 6)

Study Arms (14)

AI-09 Dose 1

EXPERIMENTAL

Dose 1 of botulinum toxin, Type A, intramuscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 1

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

AI-09 Dose 2

EXPERIMENTAL

Dose 2 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 2

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

AI-09 Dose 3

EXPERIMENTAL

Dose 3 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 3

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

AI-09 Dose 4

EXPERIMENTAL

Dose 4 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 4

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

AI-09 Dose 5

EXPERIMENTAL

Dose 5 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 5

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

AI-09 Dose 6

EXPERIMENTAL

Dose 6 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 6

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

AI-09 Dose 7

EXPERIMENTAL

Dose 7 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Biological: AI-09

Vehicle Dose 7

PLACEBO COMPARATOR

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle

Interventions

AI-09BIOLOGICAL

Botulinum toxin, Type A, intramuscular injection, administered once at baseline

AI-09 Dose 1AI-09 Dose 2AI-09 Dose 3AI-09 Dose 4AI-09 Dose 5AI-09 Dose 6AI-09 Dose 7
VehicleBIOLOGICAL

Vehicle Formulation

Vehicle Dose 1Vehicle Dose 2Vehicle Dose 3Vehicle Dose 4Vehicle Dose 5Vehicle Dose 6Vehicle Dose 7

Eligibility Criteria

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

You may qualify if:

  • able to understand and give written informed consent
  • willingness to have their pictures taken
  • years of age
  • moderate to severe glabellar lines (IGA 2-3) on contraction
  • moderate to severe glabellar lines (SSA 2-3) on contraction
  • none to mild glabellar lines wrinkles (IGA 0-1) at rest
  • willingness to refrain from the use of facial fillers, retinoids, Botox, laser treatments, or any product affecting skin remodeling or that might cause an active dermal response during the course of the study
  • female subjects of child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline visit
  • female subjects of child-bearing potential must utilize one of the following methods of birth control throughout the study: IUD, diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 4 months prior to Baseline and has not changed the brand within this period), or patch, injectable, implantable, or vaginal ring contraceptives. Subjects may also participate if they are surgically sterilized (tubal sterilization or hysterectomy)
  • subjects 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
  • excessive weakness or atrophy in the target muscle(s)
  • eyelid ptosis
  • 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 a 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
  • subjects on clinically significant, concomitant drug therapy
  • participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline
  • alcohol or drug abuse within the past 3 years
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eirion Research Site

Boca Raton, Florida, 33432, United States

Location

Eirion Research Site

Miami, Florida, 33137, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 4, 2022

Study Start

September 3, 2022

Primary Completion

June 3, 2024

Study Completion

June 3, 2024

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)