Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area (JBDX)

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.

Study Overview

• Status: Completed
• Conditions: Cosmetic Techniques
• Intervention / Treatment: Drug: Onabotulinumtoxina for Injection; Drug: Abobotulinumtoxina for Injection; Drug: IncobotulinumtoxinA for Injection; Drug: PrabotulinumtoxinA for Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robyn Broach, PhD; Phone Number: 215-662-7300; Email: robyn.broach@pennmedicine.upenn.edu
• Study Contact Backup: Name: Ivona Percec, MD, PhD; Phone Number: 215-662-7300; Email: ivona.percec@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Botox; Dysport; cosmetic; Xeomin; glabella; minimally invasive procedures; facial rejuvenation; forehead; neurotoxins; eyebrow area; Jeuveau; cosmetic injections; wrinkle reduction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
• Other Study ID Numbers: 849045

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes