Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area

Study Overview
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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.

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.

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

Conditions
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Cosmetic Techniques

Intervention / Treatment
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* Drug: Onabotulinumtoxina for Injection
* Drug: Abobotulinumtoxina for Injection
* Drug: IncobotulinumtoxinA for Injection
* Drug: PrabotulinumtoxinA for Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 30-65 years of age Interested in glabellar injections to reduce rhytids and facial strain Participants must sign the informed consent form Exclusion Criteria: Females under 30 or above 65 years of age Males Those who have received glabellar injections for rhytids <12 months Underwent cosmetic surgical procedure above the malar region Those with a condition that affects facial expression, such as prior stroke

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial in which patients will be randomly assigned into one of four groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OnabotulinumtoxinA<br>Botox | Drug: Onabotulinumtoxina for Injection<br>* cosmetic injection into the glabella area (eyebrow area)<br>* Other names: Botox;|
| Active Comparator: AbobotulinumtoxinA<br>Dysport | Drug: Abobotulinumtoxina for Injection<br>* cosmetic injection into the glabella area (eyebrow area)<br>* Other names: Dysport;|
| Active Comparator: IncobotulinumtoxinA<br>Xeomin | Drug: IncobotulinumtoxinA for Injection<br>* cosmetic injection into the glabella area (eyebrow area)<br>* Other names: Xeomin;|
| Active Comparator: PrabotulinumtoxinA<br>Jeuveau | Drug: PrabotulinumtoxinA for Injection<br>* cosmetic injection into the glabella area (eyebrow area)<br>* Other names: Jeuveau;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in dynamic strain in the glabella area after injection over time | the change in dynamic strain of the glabella area after injection using 3D facial imaging measurements over time | baseline, day 3, day 30, day 90, day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in dynamic strain in the glabella area after injections over time between two facial animations | the degree of stretch, lift (dynamic strain) of two facial animations (relaxed and frowning) | baseline, day 3, day 30, day 90, day 180 | 
| assess patient reported satisfaction (FACE-Q) to the degree of dynamic strain overtime | assess patient reported satisfaction (FACE-Q) to the degree of dynamic strain overtime. All modules of the FACE-Q create a total score converted to 0 to 100. Higher scores for all modules except 2 (Expectations and Appearance-related Distress) reflect a better outcome. | baseline, day 3, day 30, day 90, day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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minimally invasive procedures, neurotoxins, cosmetic, Botox, eyebrow area, glabella, Dysport, Jeuveau, Xeomin, forehead, cosmetic injections, facial rejuvenation, wrinkle reduction