Botulinum Toxin Type A for Frown Lines

Recruiting at 2 trial locations

Overseen By Patrick Murphy

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Eirion Therapeutics Inc.

Must not be taking: Botulinum toxin

Disqualifiers: Dry eye, Periocular surgery, Myasthenia gravis, others

Compensation: Varies

Number of Visits: 28

Duration: 1 day

72 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug AI-09 for frown lines?

Research shows that botulinum toxin type A, similar to AI-09, is effective in reducing frown lines. In a study, 77% of patients treated with botulinum toxin type A showed significant improvement in glabellar lines compared to those who received a placebo. ^{1 2 3 4 5}

Is botulinum toxin type A safe for treating frown lines?

Botulinum toxin type A is generally considered safe for treating frown lines, with studies showing low rates of mild side effects like headache and eyelid drooping. It has been used effectively in cosmetic dermatology with a good safety profile. ^{2 3 4 6 7}

How is the drug AI-09 different from other treatments for frown lines?

AI-09, also known as incobotulinumtoxinA, is unique because it is a form of botulinum toxin type A that is free from complexing proteins, which may reduce the risk of immune reactions compared to other formulations that contain these proteins. ^{2 3 4 7 8}

What is the purpose of this trial?

This trial is testing a new treatment called AI-09 to see if it can safely and effectively reduce frown lines between the eyebrows. It focuses on people who have these lines and want to lessen their appearance.

Eligibility Criteria

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

I am between 20 and 70 years old.

Able to understand and give written informed consent

I am willing to have my pictures taken for the study.

Exclusion Criteria

Psychiatric disease interfering with the subject's ability to give informed consent

History of immunization or hypersensitivity to any botulinum toxin serotype

My eyelid droops.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular injection of AI-09 or vehicle at baseline

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

Visits at Week 1, 2, 4, 8, 12, 18

Extended Follow-up

Additional monitoring for Cohorts 4, 5, and 6

26 weeks

Additional visit at Week 26

Treatment Details

Interventions

• AI-09

Trial Overview The GL-101 trial tests AI-09 against a placebo (vehicle) in reducing glabellar (frown) lines. Participants will be randomly assigned to receive either AI-09 or a placebo treatment and will be photographed to assess changes in their frown lines over time.

Participant Groups

Group I: AI-09 Dose 7 Experimental Treatment 1 Intervention

Dose 7 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Group II: AI-09 Dose 6 Experimental Treatment 1 Intervention

Dose 6 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Group III: AI-09 Dose 5 Experimental Treatment 1 Intervention

Dose 5 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Group IV: AI-09 Dose 4 Experimental Treatment 1 Intervention

Dose 4 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Group V: AI-09 Dose 3 Experimental Treatment 1 Intervention

Dose 3 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Group VI: AI-09 Dose 2 Experimental Treatment 1 Intervention

Dose 2 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline

Group VII: AI-09 Dose 1 Experimental Treatment 1 Intervention

Dose 1 of botulinum toxin, Type A, intramuscular injection, administered once at baseline

Group VIII: Vehicle Dose 7 Placebo Group 1 Intervention

Vehicle, intramuscular injection, administered once at baseline

Group IX: Vehicle Dose 4 Placebo Group 1 Intervention

Vehicle, intramuscular injection, administered once at baseline

Group X: Vehicle Dose 1 Placebo Group 1 Intervention

Vehicle, intramuscular injection, administered once at baseline

Group XI: Vehicle Dose 2 Placebo Group 1 Intervention

Vehicle, intramuscular injection, administered once at baseline

Group XII: Vehicle Dose 3 Placebo Group 1 Intervention

Vehicle, intramuscular injection, administered once at baseline

Group XIII: Vehicle Dose 5 Placebo Group 1 Intervention

Vehicle, intramuscular injection, administered once at baseline

Group XIV: Vehicle Dose 6 Placebo Group 1 Intervention

Vehicle, intramuscular injection, administered once at baseline

Who Is Running the Clinical Trial?

Eirion Therapeutics Inc.

Lead Sponsor

Trials

6

Recruited

590+

Findings from Research

In a Phase III trial involving 105 participants, incobotulinumtoxinA demonstrated high efficacy for treating moderate-to-severe glabellar frown lines, with 98.1% of subjects showing improvement at Day 28 and 80.0% at Day 84.

The treatment was well tolerated, with a low incidence of adverse events and no development of neutralizing antibodies, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines. Imhof, M., Kühne, U.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of self-esteem and depression symptoms in depressed and nondepressed subjects treated with onabotulinumtoxinA for glabellar lines. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines. [2015]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety, efficacy, and onset of a novel botulinum toxin type A (Nabota) for the treatment of glabellar frown lines: a single-arm, prospective, phase 4 clinical study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA for Glabellar Frown Lines in Chinese Subjects: A Randomized, Double-blind, Active-Controlled Phase-3 Study. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Botulinum toxin A: its expanding role in dermatology and esthetics. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Multicenter, randomized, phase III study of a single dose of incobotulinumtoxinA, free from complexing proteins, in the treatment of glabellar frown lines. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Quantification of the efficacy of botulinum toxin type A by digital image analysis. [2019]