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A Randomized Prospective Evaluation of Four Injectable Neuromodulators in the Glabella Area
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.
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.
Age
30 - 65 years
Sex
FEMALE
Healthy Volunteers
No
Penn Medicine
Philadelphia, Pennsylvania, United States
Start Date
March 4, 2022
Primary Completion Date
June 30, 2023
Completion Date
June 30, 2023
Last Updated
January 17, 2025
143
ACTUAL participants
Onabotulinumtoxina for Injection
DRUG
Abobotulinumtoxina for Injection
DRUG
IncobotulinumtoxinA for Injection
DRUG
PrabotulinumtoxinA for Injection
DRUG
Lead Sponsor
University of Pennsylvania
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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