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

University of Pennsylvania

Status: Completed

Conditions: Cosmetic Techniques

Treatments: Drug: Abobotulinumtoxina for Injection; Drug: Onabotulinumtoxina for Injection; Drug: PrabotulinumtoxinA for Injection; Drug: IncobotulinumtoxinA for Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05167864

849045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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143 participants in 4 patient groups

OnabotulinumtoxinA

Active Comparator group

Description:

Botox

Treatment:

Drug: Onabotulinumtoxina for Injection

AbobotulinumtoxinA

Active Comparator group

Description:

Dysport

Treatment:

Drug: Abobotulinumtoxina for Injection

IncobotulinumtoxinA

Active Comparator group

Description:

Xeomin

Treatment:

Drug: IncobotulinumtoxinA for Injection

PrabotulinumtoxinA

Active Comparator group

Description:

Jeuveau

Treatment:

Drug: PrabotulinumtoxinA for Injection