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Depth of Botulinum Neurotoxin Injection for Treatment of Glabellar Lines

NCT05766683 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-12

No results posted yet for this study

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

Conditions

  • Glabellar Frown Lines

Interventions

DRUG

onabotulinumtoxinA at a depth of 2mm

One time administration of onabotulinumtoxinA to the corrugator supercilii muscles bilaterally. Dosing dependent on the baseline mass and volume of subject's glabellar muscles as assessed by trained cosmetic dermatologist, accounting for symmetry/asymmetry of the face and can range from 10-50 units. Will be administered at a depth of 2mm

DRUG

onabotulinumtoxinA at a depth of 4mm

One time administration of onabotulinumtoxinA to the corrugator supercilii muscles bilaterally. Dosing dependent on the baseline mass and volume of subject's glabellar muscles as assessed by trained cosmetic dermatologist, accounting for symmetry/asymmetry of the face and can range from 10-50 units. Will be administered at a depth of 4mm

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • David Ozog, MD · Henry Ford Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2023-06-20
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05766683 on ClinicalTrials.gov