AI-09 Dose 3 for Frown Lines

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Frown LinesAI-09 - Biological
Eligibility
20 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trial found that the use of botulinum toxin type A significantly improved the appearance of glabellar lines.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Week 1, 2, 4, 8, 12, 18

18 Weeks
Investigators Global Assessment (IGA)
Week 1
Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score

Trial Safety

Safety Progress

1 of 3

Trial Design

32 Treatment Groups

AI-09 Dose 3
1 of 32
AI-09 Dose 4
1 of 32
AI-09 Dose 5
1 of 32
AI-09 3.5U
1 of 32
AI-09 23.8U
1 of 32
AI-09 14U
1 of 32
AI-09 68.8U
1 of 32
AI-09 40.4U
1 of 32
AI-09 7.0U
1 of 32
AI-09, Dose 1
1 of 32
AI-09, Dose 2
1 of 32
AI-09, Dose 5
1 of 32
AI-09, Dose 3
1 of 32
AI-09, Dose 4
1 of 32
AI-09, Dose 6
1 of 32
AI-09 Dose 6
1 of 32
AI-09 Dose 1
1 of 32
AI-09 Dose 2
1 of 32
Vehicle Dose 3
1 of 32
Vehicle Dose 4
1 of 32
Dose 4 Vehicle
1 of 32
Dose 3 Vehicle
1 of 32
Dose 1 Vehicle
1 of 32
Dose 2 Vehicle
1 of 32
Dose 6 Vehicle
1 of 32
Dose 5 Vehicle
1 of 32
Dose, 2 Vehicle
1 of 32
Dose, 1 Vehicle
1 of 32
Vehicle Dose 5
1 of 32
Vehicle Dose 6
1 of 32
Vehicle Dose 1
1 of 32
Vehicle Dose 2
1 of 32

Experimental Treatment

Non-Treatment Group

72 Total Participants · 32 Treatment Groups

Primary Treatment: AI-09 Dose 3 · Has Placebo Group · Phase 1 & 2

AI-09 Dose 3
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09 Dose 4
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09 Dose 5
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09 3.5U
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09 23.8U
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09 14U
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09 68.8U
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09 40.4U
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09 7.0U
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09, Dose 1
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09, Dose 2
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09, Dose 5
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09, Dose 3
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09, Dose 4
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09, Dose 6
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09 Dose 6
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09 Dose 1
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
AI-09 Dose 2
Biological
Experimental Group · 1 Intervention: AI-09 · Intervention Types: Biological
Vehicle Dose 3
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological
Vehicle Dose 4
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological
Dose 4 Vehicle
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological
Dose 3 Vehicle
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological
Dose 1 Vehicle
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological
Dose 2 Vehicle
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological
Dose 6 Vehicle
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological
Dose 5 Vehicle
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological
Dose, 2 Vehicle
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological
Dose, 1 Vehicle
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological
Vehicle Dose 5
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological
Vehicle Dose 6
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological
Vehicle Dose 1
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological
Vehicle Dose 2
Biological
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 1, 2, 4, 8, 12, 18

Who is running the clinical trial?

Eirion Therapeutics Inc.Lead Sponsor
5 Previous Clinical Trials
520 Total Patients Enrolled

Eligibility Criteria

Age 20 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have 20 - 70 years of age.
You have moderate to severe glabellar lines (IGA 2-3) on contraction.
You have moderate to severe glabellar lines (SSA 2-3) on contraction.
You have mild to moderate glabellar lines wrinkles (IGA 0-1) at rest.
You are willing 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.
Subjects must be female subjects of child-bearing potential who have not used a method of birth control for at least 4 months prior to enrollment in this study.
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 are female and non-lactating at the Baseline visit.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Baumann Cosmetic & Research Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%