Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area

University of Pennsylvania143 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

143

Conditions

Cosmetic Techniques

Interventions

Onabotulinumtoxina for InjectionDRUG

cosmetic injection into the glabella area (eyebrow area)

Abobotulinumtoxina for InjectionDRUG

cosmetic injection into the glabella area (eyebrow area)

IncobotulinumtoxinA for InjectionDRUG

cosmetic injection into the glabella area (eyebrow area)

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Penn Medicine

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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 At each visit two images were captured, one neutral and one dynamic. The neutral face was relaxed and served as a reference while the dynamic face was the subject's expression when asked to furrow their glabella by frowning (compressed face). A decrease in strain indicates reduced compression, as there is a smaller difference between the neutral face and the dynamic, or compressed, face.

Time frame: day 3, day 30, day 90, day 180

Secondary Outcomes

Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime

Correlation of patient reported satisfaction (FACE-Q) to the degree of dynamic strain overtime. Correlation is determined at each time point post intervention Day 3, Day 30, Day 90 and Day 180.

Time frame: baseline, day 3, day 30, day 90, day 180

Data from ClinicalTrials.gov

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