Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area

Cosmetic Techniques Clinical Trial

— JBDX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05167864
• Other study ID #: 849045
• Status: Completed
• Phase: N/A
• Start date: March 4, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cosmetic Techniques

Intervention

Drug:
• Onabotulinumtoxina for Injection
cosmetic injection into the glabella area (eyebrow area)
• Abobotulinumtoxina for Injection
cosmetic injection into the glabella area (eyebrow area)
• IncobotulinumtoxinA for Injection
cosmetic injection into the glabella area (eyebrow area)
• PrabotulinumtoxinA for Injection
cosmetic injection into the glabella area (eyebrow area)

Locations

Country	Name	City	State
United States	Penn Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline, day 3, day 30, day 90, day 180
Secondary	the change in dynamic strain in the glabella area after injections over time between two facial animations	the degree of stretch, lift (dynamic strain) of two facial animations (relaxed and frowning)	baseline, day 3, day 30, day 90, day 180
Secondary	assess patient reported satisfaction (FACE-Q) to the degree of dynamic strain overtime	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.	baseline, day 3, day 30, day 90, day 180