Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-04

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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

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Cosmetic Techniques

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial in which patients will be randomly assigned into one of four groups

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

blinding of participant and provider administering the treatment

Study Groups

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OnabotulinumtoxinA

Botox

Group Type ACTIVE_COMPARATOR