Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area

Not Applicable

Completed

• Conditions: Cosmetic Techniques
• Interventions: Drug: Onabotulinumtoxina for Injection; Drug: Abobotulinumtoxina for Injection; Drug: IncobotulinumtoxinA for Injection; Drug: PrabotulinumtoxinA for Injection

• Registration Number: NCT05167864
• Lead Sponsor: University of Pennsylvania

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2021-12-22
• Study Start: 2022-03-04
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 143

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OnabotulinumtoxinA	Onabotulinumtoxina for Injection	Botox
AbobotulinumtoxinA	Abobotulinumtoxina for Injection	Dysport
IncobotulinumtoxinA	IncobotulinumtoxinA for Injection	Xeomin
PrabotulinumtoxinA	PrabotulinumtoxinA for Injection	Jeuveau

Primary Outcome Measures

Name	Time	Method
the change in dynamic strain in the glabella area after injection over time	baseline, day 3, day 30, day 90, day 180	the change in dynamic strain of the glabella area after injection using 3D facial imaging measurements over time

Secondary Outcome Measures

Name	Time	Method
assess patient reported satisfaction (FACE-Q) to the degree of dynamic strain overtime	baseline, day 3, day 30, day 90, day 180	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.
the change in dynamic strain in the glabella area after injections over time between two facial animations	baseline, day 3, day 30, day 90, day 180	the degree of stretch, lift (dynamic strain) of two facial animations (relaxed and frowning)

Trial Locations

Locations (1)

Penn Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States