JBDX: Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT05167864

Collaborator

(none)

140

Enrollment

Locations

Arms

17.9

Anticipated Duration (Months)

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cosmetic Techniques	Drug: Onabotulinumtoxina for Injection Drug: Abobotulinumtoxina for Injection Drug: IncobotulinumtoxinA for Injection Drug: PrabotulinumtoxinA for Injection	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Care Provider)

Masking Description:

blinding of participant and provider administering the treatment

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 4, 2022

Anticipated Primary Completion Date :

May 30, 2023

Anticipated Study Completion Date :

Aug 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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)
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.