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AI-09 In Subjects With Glabellar Lines, GL-101

Sponsor
Eirion Therapeutics Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05565950
Collaborator
(none)
72
Enrollment
1
Location
12
Arms
10.9
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

AI-09 In Subjects with Glabellar Lines

Condition or Disease Intervention/Treatment Phase
  • Biological: AI-09
  • Biological: Vehicle
 Phase 1/Phase 2

Detailed Description

A Phase 1/2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled study to establish an initial therapeutic range for AI-09 in the treatment of glabellar lines and provide initial data regarding its potential safety.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study to Establish An Initial Therapeutic Range and Safety Data for AI-09 in the Treatment of Glabellar Lines
Actual Study Start Date :
Oct 3, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: AI-09 Dose 1

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

Biological: AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Placebo Comparator: Vehicle Dose 1

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle
Vehicle Formulation
Experimental: AI-09 Dose 2

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

Biological: AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Placebo Comparator: Vehicle Dose 2

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle
Vehicle Formulation
Experimental: AI-09 Dose 3

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

Biological: AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Placebo Comparator: Vehicle Dose 3

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle
Vehicle Formulation
Experimental: AI-09 Dose 4

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

Biological: AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Placebo Comparator: Vehicle Dose 4

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle
Vehicle Formulation
Experimental: AI-09 Dose 5

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

Biological: AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Placebo Comparator: Vehicle Dose 5

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle
Vehicle Formulation
Experimental: AI-09 Dose 6

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

Biological: AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Placebo Comparator: Vehicle Dose 6

Vehicle, intramuscular injection, administered once at baseline

Biological: Vehicle
Vehicle Formulation

Outcome Measures

Primary Outcome Measures

  1. Investigators Global Assessment (IGA) [18 Weeks]

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

Secondary Outcome Measures

  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]

    Total number of observations with a change in the Investigators Global Assessment on Contraction, IGA-C, and the Subject Self-Assessment on Contraction, SSA-C, using the Glabellar Line Severity scale (GLS), where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as a change by at least two ordinals in both assessments.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • able to understand and give written informed consent

  • willingness to have their pictures taken

  • 20 - 70 years of age

  • moderate to severe glabellar lines (IGA 2-3) on contraction

  • moderate to severe glabellar lines (SSA 2-3) on contraction

  • mild to moderate 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

Exclusion Criteria:

  • 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

  • psychiatric disease interfering with the subject's ability to give informed consent

  • refusal or inability to comply with the requirements of the protocol for any reason

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baumann Cosmetic & Research Institute Miami Florida United States 33137

Sponsors and Collaborators

  • Eirion Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eirion Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT05565950
Other Study ID Numbers:
  • AI-09-GL-101
First Posted:
Oct 4, 2022
Last Update Posted:
Oct 13, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Oct 13, 2022