Glabellar Frown LinesPhase 1/2NCT05565950
AI-09 In Subjects With Glabellar Lines, GL-101
A Phase 1/2 study testing AI-09 in people with Glabellar Frown Lines, run by Eirion Therapeutics Inc. at 4 sites in United States.
Trial summary
AI-09 In Subjects with Glabellar Lines Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- AI-09
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Oct 2022to 22 May 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- none to mild glabellar lines wrinkles (IGA 0-1) at rest
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Eirion Research Site
Boca Raton, Florida, 33432
Eirion Research Site
Miami, Florida, 33137
Eirion Research Site
New Brighton, Minnesota, 55112
Eirion Research Site
Plano, Texas, 75093
About this study
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
AI-09 In Subjects with Glabellar Lines
Read the 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.
- Conditions
- Glabellar Frown Lines
- Being tested
- AI-09, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-09Biological
Injectable Botulinum Toxin Type A
VehicleBiological
Vehicle Formulation
| Study group | Role | What they receive |
|---|---|---|
| AI-09 Dose 1 | Experimental | Dose 1 of botulinum toxin, Type A, intramuscular injection, administered once at baseline Receives: Biological: AI-09 |
| Vehicle Dose 1 | Placebo comparator | Vehicle, intramuscular injection, administered once at baseline Receives: Biological: Vehicle |
| AI-09 Dose 2 | Experimental | Dose 2 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline Receives: Biological: AI-09 |
| Vehicle Dose 2 | Placebo comparator | Vehicle, intramuscular injection, administered once at baseline Receives: Biological: Vehicle |
| AI-09 Dose 3 | Experimental | Dose 3 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline Receives: Biological: AI-09 |
| Vehicle Dose 3 | Placebo comparator | Vehicle, intramuscular injection, administered once at baseline Receives: Biological: Vehicle |
| AI-09 Dose 4 | Experimental | Dose 4 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline Receives: Biological: AI-09 |
| Vehicle Dose 4 | Placebo comparator | Vehicle, intramuscular injection, administered once at baseline Receives: Biological: Vehicle |
| AI-09 Dose 5 | Experimental | Dose 5 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline Receives: Biological: AI-09 |
| Vehicle Dose 5 | Placebo comparator | Vehicle, intramuscular injection, administered once at baseline Receives: Biological: Vehicle |
| AI-09 Dose 6 | Experimental | Dose 6 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline Receives: Biological: AI-09 |
| Vehicle Dose 6 | Placebo comparator | Vehicle, intramuscular injection, administered once at baseline Receives: Biological: Vehicle |
| AI-09 Dose 7 | Experimental | Dose 7 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline Receives: Biological: AI-09 |
| Vehicle Dose 7 | Placebo comparator | Vehicle, intramuscular injection, administered once at baseline Receives: Biological: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Responders by Dose Group at the Week 4 Visit; R=I+S-C≤1
Investigator and Subject Assessment (R=I+S-C≤1), percentage of responders achieving a score of 0 (Absent) or 1 (Mild) on the Glabellar Line Severity scale where severity is scored between 0-3 (0=absent; 3=severe).
Measured: 4 Weeks
Secondary outcomes (1)
% of Responders at Week 4 With Improvement From Baseline On-contraction by at Least 2 Points by Investigator and Subject's Self Assessment (I+S-C CfB≥2), on the Glabellar Line Severity Scale Where Severity is Scored Between 0-3 (0=Absent; 3=Severe).
% of responders with improvement in the Investigator and Subject's Self Assessment on Contraction, IGA-C, using the Glabellar Line Severity scale (GLS), where severity is scored between 0-3 (0=absent; 3=severe). A "responder" is defined as a change by at least two ordinals assessments.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start3 Oct 2022
- Primary completion5 Jan 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glabellar Frown LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eirion Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Eppolito, Study director, Eirion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565950
- Sponsor's protocol ID
- AI-09-GL-101
- Status last verified
- Aug 2026
- First submitted
- 27 Sep 2022
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05565950
- Acronym / sponsor ID
- AI-09-GL-101
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Eirion Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AI-09 In Subjects with Glabellar Lines
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| AI-09 Dose 1 | Experimental | Biological: AI-09Dose 1 of botulinum toxin, Type A, intramuscular injection, administered once at baseline |
| Vehicle Dose 1 | Placebo comparator | Biological: VehicleVehicle, intramuscular injection, administered once at baseline |
| AI-09 Dose 2 | Experimental | Biological: AI-09Dose 2 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline |
| Vehicle Dose 2 | Placebo comparator | Biological: VehicleVehicle, intramuscular injection, administered once at baseline |
| AI-09 Dose 3 | Experimental | Biological: AI-09Dose 3 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline |
| Vehicle Dose 3 | Placebo comparator | Biological: VehicleVehicle, intramuscular injection, administered once at baseline |
| AI-09 Dose 4 | Experimental | Biological: AI-09Dose 4 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline |
| Vehicle Dose 4 | Placebo comparator | Biological: VehicleVehicle, intramuscular injection, administered once at baseline |
| AI-09 Dose 5 | Experimental | Biological: AI-09Dose 5 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline |
| Vehicle Dose 5 | Placebo comparator | Biological: VehicleVehicle, intramuscular injection, administered once at baseline |
| AI-09 Dose 6 | Experimental | Biological: AI-09Dose 6 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline |
| Vehicle Dose 6 | Placebo comparator | Biological: VehicleVehicle, intramuscular injection, administered once at baseline |
| AI-09 Dose 7 | Experimental | Biological: AI-09Dose 7 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline |
| Vehicle Dose 7 | Placebo comparator | Biological: VehicleVehicle, intramuscular injection, administered once at baseline |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-09Injectable Botulinum Toxin Type A | Biological | AI-09 Dose 1, AI-09 Dose 2, AI-09 Dose 3, AI-09 Dose 4, AI-09 Dose 5, AI-09 Dose 6, AI-09 Dose 7 |
| VehicleVehicle Formulation | Biological | Vehicle Dose 1, Vehicle Dose 2, Vehicle Dose 3, Vehicle Dose 4, Vehicle Dose 5, Vehicle Dose 6, Vehicle Dose 7 |
Primary outcome
Percentage of Responders by Dose Group at the Week 4 Visit; R=I+S-C≤1
Time frame: 4 Weeks
Investigator and Subject Assessment (R=I+S-C≤1), percentage of responders achieving a score of 0 (Absent) or 1 (Mild) on the Glabellar Line Severity scale where severity is scored between 0-3 (0=absent; 3=severe).
1 secondary outcome
% of Responders at Week 4 With Improvement From Baseline On-contraction by at Least 2 Points by Investigator and Subject's Self Assessment (I+S-C CfB≥2), on the Glabellar Line Severity Scale Where Severity is Scored Between 0-3 (0=Absent; 3=Severe).
Time frame: 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Eppolito study director
Eirion Therapeutics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AI-09 in people with Glabellar Frown Lines, run by Eirion Therapeutics Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Responders by Dose Group at the Week 4 Visit; R=I+S-C≤1 (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.