drugset / Trial / NCT05766683

Depth of Botulinum Neurotoxin Injection for Treatment of Glabellar Lines

NCT05766683

Phase 1 Active not recruiting 20 enrolled Henry Ford Health System
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2023-03-14
Primary completion
2023-06-20
Completion
2026-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 10 iu
Subject Botulinum toxin type A Protein / enzyme biologic 50 iu

Indications

No indication recorded.