Depth of Botulinum Neurotoxin Injection for Treatment of Glabellar Lines

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

STUDY QUESTION: Does the depth of injection of onabotulinumtoxinA neurotoxin in the glabellar complex affect efficacy of the BoTN for the improvement of glabellar frown lines? STUDY AIM

• Primary objective: Compare the efficacy of onabotulinumtoxinA neurotoxin injected at the depth of 2mm vs 4mm for the improvement of glabellar lines

• Secondary objective: Determine any adverse effects of onabotulinumtoxinA neurotoxin injected at the depth of 2mm vs 4mm

RATIONALE FOR THE PROJECT:

Although the use of BoTN for treatment of glabellar lines has long been established as safe and effective, the optimal depth of injection has not been established. Our project hopes to establish the optimal depth of injection for onabotulinumtoxinA neurotoxin for maximal improvement of glabellar lines with minimal adverse effects

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Henry Ford Health System
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

1. Patient age 18 and older

2. Patient able to understand requirements of the study and risks involved

3. Patient able to sign a consent form

Exclusion Criteria:

1. A patient who is lactating, pregnant, or planning to become pregnant

2. Prior history of botulinum neurotoxin treatment of the face within the past one (1) year

3. History of hypersensitivity to botulinum neurotoxin

4. History of neuromuscular disorders (e.g., myasthenia gravis)

5. History of facial surgery or scars in the treatment area that may confound study results