NCT05167864

Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area

A Randomized Prospective Evaluation of Four Injectable Neuromodulators in the Glabella Area

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to use 3D imaging to evaluate the effects of four FDA approved neuromodulators on facial lines, wrinkles and animation. Participation is available to women who have never had a cosmetic procedure above the malar region nor a treatment with a neuromodulator within 12 months. All subjects will undergo 3D imaging using the VECTRA M3 (Canfield Scientific, Inc, Fairfield, NJ) prior to treatment with a neuromodulator in order to determine their baseline dimensions. Imaging will be repeated post injection to determine change over time.

Detailed description

This study is a randomized controlled trial in which patients will be randomly assigned into one of four groups: those receiving onabotulinumtoxinA (Botox, Allergan, Irvine, California), abobotulinumtoxinA (Dysport, Ispen Biopharmacueticals Inc.Cambridge, MA), incobotulinumtoxinA (Xeomin, Raleigh, NC) or prabotulinumtoxinA (Jeuveau, Evolus, Newport Beach, California). Each patient will receive FDA approved dosages in which they are assigned in to treat rhytids within the glabella, as per FDA approved indications. All injections will be performed by a blinded single trained physician according to a preset injection plan per FDA approved administration guidelines. Prior to injection patients will be imaged with 3-dimensional photogrammetry. All pre-procedure images will be evaluated for absolute strain performing two types of facial animation: 1) relaxed, and 2) frowning. Subjects will return Day 3, 30, 90, and 180, post intervention for re-imaging with the same expressions. Strain will be calculated using the same metrics.

Conditions

• Cosmetic Techniques

Interventions

Type	Name	Description
DRUG	Onabotulinumtoxina for Injection	cosmetic injection into the glabella area (eyebrow area)
DRUG	Abobotulinumtoxina for Injection	cosmetic injection into the glabella area (eyebrow area)
DRUG	IncobotulinumtoxinA for Injection	cosmetic injection into the glabella area (eyebrow area)
DRUG	PrabotulinumtoxinA for Injection	cosmetic injection into the glabella area (eyebrow area)

Timeline

• Start date: 2022-03-04
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2021-12-22
• Last updated: 2025-01-17
• Results posted: 2025-01-17

Locations

1 site across 1 country: United States