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Depth of Botulinum Neurotoxin Injection for Treatment of Glabellar Lines
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
Details
| Lead sponsor | Henry Ford Health System |
|---|---|
| Phase | Phase 1 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 20 |
| Start date | 2023-03-14 |
| Completion | 2026-12 |
Conditions
- Glabellar Frown Lines
Interventions
- onabotulinumtoxinA at a depth of 2mm
- onabotulinumtoxinA at a depth of 4mm
Primary outcomes
- Injection of onabotulinumtoxinA, 2 mm depth — 120 days
Assess the efficacy of onabotulinumtoxinA neurotoxin injected at the depth of 2mm for the improvement of glabellar lines using the Merz aesthetics scales. The Merz scale is as follows: 0 - no glabellar lines 1- mild glabellar lines 2 - moderate glabellar lines 3 - severe glabellar lines 4 - very severe glabellar lines - Injection of onabotulinumtoxinA, 4 mm depth — 120 days
Assess the efficacy of onabotulinumtoxinA neurotoxin injected at the depth of 4mm for the improvement of glabellar lines using the Merz aesthetics scales. The Merz scale is as follows: 0 - no glabellar lines 1- mild glabellar lines 2 - moderate glabellar lines 3 - severe glabellar lines 4 - very severe glabellar lines
Countries
United States