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OpenTrials
Completed

NCT Number: NCT05167864

Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area

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.

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Key information

Conditions

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Onabotulinumtoxina for Injection

Drug

cosmetic injection into the glabella area (eyebrow area)

Other names: Botox

Abobotulinumtoxina for Injection

Drug

cosmetic injection into the glabella area (eyebrow area)

Other names: Dysport

IncobotulinumtoxinA for Injection

Drug

cosmetic injection into the glabella area (eyebrow area)

Other names: Xeomin

PrabotulinumtoxinA for Injection

Drug

cosmetic injection into the glabella area (eyebrow area)

Other names: Jeuveau

Primary outcomes

  1. the Change in Dynamic Strain in the Glabella Area After Injection Over Time

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: JBDX

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 22, 2021
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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