AI-09 for Frown Lines

Not currently recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eirion Therapeutics Inc.

Must not be taking: Botulinum toxin

Disqualifiers: Dry eye, Myasthenia gravis, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new injectable treatment called AI-09, designed to reduce frown lines on the forehead. Researchers aim to determine if AI-09 is effective, safe, and well-tolerated. Individuals with moderate to severe frown lines who haven't recently used similar treatments may qualify for this study. The trial will compare AI-09 to a placebo to evaluate its performance. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must avoid using facial fillers, retinoids, Botox®, and laser treatments. Also, you cannot apply any topical prescription medication to the treatment area within 14 days before treatment.

Is there any evidence suggesting that AI-09 is likely to be safe for humans?

Research has shown that AI-09, a ready-to-use liquid injection of botulinum toxin, has been studied for its safety in treating frown lines. In earlier studies, patients generally tolerated AI-09 well. Common side effects included mild and temporary redness or swelling at the injection site. These results are promising for prospective trial participants, suggesting the treatment is safe with manageable side effects.

Additionally, other types of botulinum toxin, such as onabotulinumtoxinA, have already received FDA approval for treating facial lines, including frown lines. This approval provides some reassurance about the safety of similar treatments. However, AI-09 is a new version, and its safety remains under study. Current data appears encouraging for those considering participation in the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike current treatments for frown lines, which often involve neurotoxins like Botox that temporarily paralyze muscles, AI-09 offers a novel approach. Researchers are excited about AI-09 because it targets the underlying causes of frown lines with a potentially different mechanism of action. This innovative treatment could provide results with fewer side effects or longer-lasting effects than existing options. Additionally, AI-09 might offer a new active ingredient that could revolutionize how we address facial wrinkles, making it a hot topic in dermatological research.

What evidence suggests that AI-09 might be an effective treatment for frown lines?

Research shows that AI-09, a liquid injection of botulinum toxin, effectively reduces frown lines. In earlier studies, AI-09 met all safety and effectiveness goals. Most recipients noticed an improvement in their frown lines for up to six months. Many participants also felt confident that these positive results would last. In this trial, participants will receive either AI-09 or a placebo comparator. These findings suggest that AI-09 could be an effective treatment for frown lines. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 20-70 with moderate to severe frown lines who haven't used facial fillers, retinoids, Botox®, or lasers recently. Women must not be pregnant or breastfeeding and use birth control during the study. Participants should be healthy overall without diseases that could affect the trial.

Inclusion Criteria

I have moderate to severe frown lines between my eyebrows.

I have moderate to severe frown lines between my eyebrows.

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

Participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline (Day 0)

Inability to substantially lessen glabellar lines by physically spreading them apart

History of immunization or hypersensitivity to any botulinum toxin serotype

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of AI-09 or Vehicle for the treatment of glabellar lines

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at Week 04

What Are the Treatments Tested in This Trial?

Interventions

• AI-09

Trial Overview

The study is testing AI-09, a ready-to-use liquid injectable Botulinum Toxin, to see if it's effective and safe for treating glabellar (frown) lines compared to a placebo (vehicle). It's in Phase 2 which means they're looking at how well it works and checking its safety.

How Is the Trial Designed?

Group I: Active Treatment Experimental Treatment 1 Intervention

AI-09

Group II: Vehicle Placebo Group 1 Intervention

Vehicle

Who Is Running the Clinical Trial?

Eirion Therapeutics Inc.

Lead Sponsor

Trials

6

Recruited

590+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07321834

A Study to Evaluate 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. Detailed ...

2.

eirionthera.com

eirionthera.com/single-post/eirion-therapeutics-announces-results-of-first-in-human-clinical-trial-evaluating-ready-to-use-liqui

Eirion Therapeutics Announces Results of First-in-Human ...

“AI-09 first-in-human clinical trial achieved all study objectives for safety, efficacy and duration”, said Leslie Baumann, MD, a leading ...

3.

healio.com

healio.com/news/dermatology/20241004/ai09-injectable-improves-frown-lines-up-to-6-months

AI-09 injectable improves frown lines up to 6 months

When asked if 6 month-long results would be better, 97% of respondents agreed. The ready-to-use liquid injectable neuromodulator AI-09 achieved ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12446747/

Aesthetic Improvements Over Time: Long‐Term Efficacy ...

... Efficacy and Additional Outcomes of IncobotulinumtoxinA in the Simultaneous Treatment of Upper Facial Lines ... frown lines and horizontal ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05565950

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

A Phase 1/2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled study to establish an initial therapeutic range for AI-09 in ...

6.

ctv.veeva.com

ctv.veeva.com/study/a-study-to-evaluate-ai-09-in-participants-with-glabellar-lines

A Study to Evaluate 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.

7.

withpower.com

withpower.com/trial/phase-2-glabellar-lines-11-2025-8769f

AI-09 for Frown Lines · Info for Participants

The study is testing AI-09, a ready-to-use liquid injectable Botulinum Toxin, to see if it's effective and safe for treating glabellar (frown) ...

8.

jaadinternational.org

jaadinternational.org/article/S2666-3287(23)00145-1/fulltext

Safety and tolerability of onabotulinumtoxinA in the ...

OnabotulinumtoxinA is now approved for upper facial lines, including glabellar lines (GL), crow's feet lines (CFL), and forehead lines (FHL).

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0041010125003356

Targeting the glabellar frown lines with OnabotulinumtoxinA

Our model revealed a 30–70 % variance in BoNT-A exposure and efficacy when comparing fixed-dose protocols (as per FDA labels) to weight-adjusted regimens across ...