Clinical trial NCT05167864: Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area
Official title: A Randomized Prospective Evaluation of Four Injectable Neuromodulators in the Glabella Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cosmetic Techniques
Keywords: minimally invasive procedures
neurotoxins
cosmetic
Botox
eyebrow area
glabella
Dysport
Jeuveau
Xeomin
forehead
cosmetic injections
facial rejuvenation
wrinkle reduction
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 143
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial in which patients will be randomly assigned into one of four groups
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the Change in Dynamic Strain in the Glabella Area After Injection Over Time
timeFrame: day 3, day 30, day 90, day 180
Secondary outcomes:
measure: Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime
timeFrame: baseline, day 3, day 30, day 90, day 180
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
References: