Botulinum Toxin Type A for Frown Lines
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AI-09, a form of botulinum toxin, to determine its ability to reduce frown lines between the eyebrows. Researchers aim to assess the effectiveness and safety of AI-09 compared to a placebo (a treatment with no active ingredient). Individuals with moderate to severe frown lines when contracting their facial muscles may qualify for this study. Participants will receive an injection and must avoid using other skin treatments during the trial. As a Phase 1, Phase 2 trial, this study focuses on understanding how AI-09 works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it does mention that subjects on clinically significant, concomitant drug therapy are excluded. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that treatments like AI-09, which use botulinum toxin Type A, are generally safe and well-tolerated. Studies have found that even higher doses can be effective without raising safety concerns. Long-term research supports its use for treating frown lines, indicating that repeated use does not cause serious problems. While some minor side effects may occur, they are usually mild and temporary. As this trial is in its early stages, the main focus is to ensure the treatment's safety for participants. Overall, existing evidence suggests that AI-09 is safe for human use.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about AI-09 for frown lines because it offers a potentially more targeted approach than current options like Botox. Unlike traditional treatments that generally work by temporarily paralyzing facial muscles, AI-09 may provide a more precise modulation of muscle activity, leading to natural-looking results with potentially fewer side effects. Additionally, the specific formulation of AI-09 could allow for a longer-lasting effect, reducing the frequency of injections needed. These features make AI-09 a promising advancement in the treatment of frown lines.
What evidence suggests that AI-09 might be an effective treatment for glabellar lines?
Research has shown that botulinum toxin type A, such as AI-09, which participants in this trial may receive, effectively treats frown lines between the eyebrows. Studies have found that higher doses can extend the effects without increasing safety risks. In some cases, these treatments last up to six months, longer than many other options. Many people report satisfaction with these longer-lasting results. Overall, botulinum toxin type A products work quickly and maintain results for an extended period, making them a promising choice for reducing frown lines.14678
Are You a Good Fit for This Trial?
This trial is for adults aged 20-70 with moderate to severe frown lines when contracting their forehead muscles, but none to mild at rest. Participants must not use facial treatments that affect skin during the study and women of childbearing age need a negative pregnancy test and birth control. People can't join if they have muscle weakness in the area, dry eye, recent botulinum toxin use, or conditions affecting neuromuscular function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intramuscular injection of AI-09 or vehicle at baseline
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extended Follow-up
Additional monitoring for Cohorts 4, 5, and 6
What Are the Treatments Tested in This Trial?
Interventions
- AI-09
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eirion Therapeutics Inc.
Lead Sponsor