Depth of Botulinum Neurotoxin Injection for Treatment of Glabellar Lines

NCT05766683 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 15627
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

botulinum toxin; facial dynamic wrinkles; glabellar complex

Outcome Measures

Primary Outcomes (2)

• Injection of onabotulinumtoxinA, 2 mm depth

  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

  120 days

• Injection of onabotulinumtoxinA, 4 mm depth

  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

  120 days

Secondary Outcomes (2)

• Secondary Outcome Measure

  120 days

• Efficacy comparison

  120 days

Study Arms (2)

2mm depth

EXPERIMENTAL

Subjects will be randomized using computer generated randomization list provided by PHS to receive onabotulinumtoxinA neurotoxin injections in the glabellar complex at depth of 2mm

Drug: onabotulinumtoxinA at a depth of 2mm

4mm depth

EXPERIMENTAL

Subjects will be randomized using computer generated randomization list provided by PHS to receive onabotulinumtoxinA neurotoxin injections in the glabellar complex at depth of 4mm

Drug: onabotulinumtoxinA at a depth of 4mm

Interventions

onabotulinumtoxinA at a depth of 4mm DRUG

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

4mm depth

onabotulinumtoxinA at a depth of 2mm DRUG

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

2mm depth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age 18 and older
• Patient able to understand requirements of the study and risks involved
• Patient able to sign a consent form

You may not qualify if:

• A patient who is lactating, pregnant, or planning to become pregnant
• Prior history of botulinum neurotoxin treatment of the face within the past one (1) year
• History of hypersensitivity to botulinum neurotoxin
• History of neuromuscular disorders (e.g., myasthenia gravis)
• History of facial surgery or scars in the treatment area that may confound study results

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (7)

• Giordano CN, Matarasso SL, Ozog DM. Injectable and topical neurotoxins in dermatology: Indications, adverse events, and controversies. J Am Acad Dermatol. 2017 Jun;76(6):1027-1042. doi: 10.1016/j.jaad.2016.11.012.

  PMID: 28522039 BACKGROUND

• Gostimir M, Liou V, Yoon MK. Safety of Botulinum Toxin A Injections for Facial Rejuvenation: A Meta-Analysis of 9,669 Patients. Ophthalmic Plast Reconstr Surg. 2023 Jan-Feb 01;39(1):13-25. doi: 10.1097/IOP.0000000000002169. Epub 2022 Mar 30.

  PMID: 35353777 BACKGROUND

• Giordano CN, Matarasso SL, Ozog DM. Injectable and topical neurotoxins in dermatology: Basic science, anatomy, and therapeutic agents. J Am Acad Dermatol. 2017 Jun;76(6):1013-1024. doi: 10.1016/j.jaad.2016.11.022.

  PMID: 28522038 BACKGROUND

• Cho Y, Lee HJ, Lee KW, Lee KL, Kang JS, Kim HJ. Ultrasonographic and Three-Dimensional Analyses at the Glabella and Radix of the Nose for Botulinum Neurotoxin Injection Procedures into the Procerus Muscle. Toxins (Basel). 2019 Sep 24;11(10):560. doi: 10.3390/toxins11100560.

  PMID: 31554222 BACKGROUND

• Lee HJ, Lee KW, Tansatit T, Kim HJ. Three-Dimensional Territory and Depth of the Corrugator Supercilii: Application to Botulinum Neurotoxin Injection. Clin Anat. 2020 Jul;33(5):795-803. doi: 10.1002/ca.23507. Epub 2019 Nov 13.

  PMID: 31637771 BACKGROUND

• Sneath J, Humphrey S, Carruthers A, Carruthers J. Injecting botulinum toxin at different depths is not effective for the correction of eyebrow asymmetry. Dermatol Surg. 2015 Jan;41 Suppl 1:S82-7. doi: 10.1097/DSS.0000000000000159.

  PMID: 25548850 BACKGROUND

• Mahmoud BH, Burnett C, Ozog D. Prospective randomized controlled study to determine the effect of topical application of botulinum toxin A for crow's feet after treatment with ablative fractional CO2 laser. Dermatol Surg. 2015 Jan;41 Suppl 1:S75-81. doi: 10.1097/01.DSS.0000452642.83894.ab.

  PMID: 25548849 BACKGROUND

Study Officials

• David Ozog, MD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair

Model Details: Subjects will be randomized using computer generated randomization list provided by PHS to either receive onabotulinumtoxinA neurotoxin injections in the glabellar complex at depth of 2mm or at depth of 4mm (or above periosteum if depth of 4mm cannot be reached)

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 13, 2023
• Study Start: March 14, 2023
• Primary Completion: June 20, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)