Trials / Completed
CompletedNCT05565950
AI-09 In Subjects With Glabellar Lines, GL-101
A Phase 1/2 Study to Establish An Initial Therapeutic Range and Safety Data for AI-09 in the Treatment of Glabellar Lines
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Eirion Therapeutics Inc. · Industry
- Sex
- All
- Age
- 20 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AI-09 | Botulinum toxin, Type A, intramuscular injection, administered once at baseline |
| BIOLOGICAL | Vehicle | Vehicle Formulation |
Timeline
- Start date
- 2022-09-03
- Primary completion
- 2024-06-03
- Completion
- 2024-06-03
- First posted
- 2022-10-04
- Last updated
- 2025-08-27
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05565950. Inclusion in this directory is not an endorsement.