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Depth of Botulinum Neurotoxin Injection for Treatment of Glabellar Lines

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study completion date: Dec 2025 to Dec 2026v7
  2. Study completion date: Dec 2024 to Dec 2025v6
  3. Re-verified, no change to tracked fieldsv5
  4. Study completion date: Dec 2023 to Dec 2024v4
  5. Primary completion date changed from estimate of Aug 2023 to Jun 20, 2023v3
  6. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2023 to Mar 14, 2023
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05766683
Lead Sponsor Henry Ford Health System
Conditions
(from sponsor)		 Glabellar Frown Lines
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov