Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area
- Conditions
- Cosmetic Techniques
- Interventions
- Drug: PrabotulinumtoxinA for Injection
- Registration Number
- NCT05167864
- Lead Sponsor
- University of Pennsylvania
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 143
- Female
- 30-65 years of age
- Interested in glabellar injections to reduce rhytids and facial strain
- Participants must sign the informed consent form
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OnabotulinumtoxinA Onabotulinumtoxina for Injection Botox AbobotulinumtoxinA Abobotulinumtoxina for Injection Dysport IncobotulinumtoxinA IncobotulinumtoxinA for Injection Xeomin PrabotulinumtoxinA PrabotulinumtoxinA for Injection Jeuveau
- Primary Outcome Measures
Name Time Method the Change in Dynamic Strain in the Glabella Area After Injection Over Time 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 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.
- Secondary Outcome Measures
Name Time Method Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime baseline, day 3, day 30, day 90, day 180 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.
Trial Locations
- Locations (1)
Penn Medicine
🇺🇸Philadelphia, Pennsylvania, United States