AI-09 for Frown Lines

Not currently recruiting at 4 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eirion Therapeutics Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

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
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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
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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?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TreatmentExperimental Treatment1 Intervention
Group II: VehiclePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eirion Therapeutics Inc.

Lead Sponsor

Trials
6
Recruited
590+