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Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05167864
Acronym
JBDX
Enrollment
143
Registered
2021-12-22
Start date
2022-03-04
Completion date
2023-06-30
Last updated
2025-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cosmetic Techniques

Keywords

minimally invasive procedures, neurotoxins, cosmetic, Botox, eyebrow area, glabella, Dysport, Jeuveau, Xeomin, forehead, cosmetic injections, facial rejuvenation, wrinkle reduction

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.

Interventions

cosmetic injection into the glabella area (eyebrow area)

DRUGAbobotulinumtoxina for Injection

cosmetic injection into the glabella area (eyebrow area)

DRUGIncobotulinumtoxinA for Injection

cosmetic injection into the glabella area (eyebrow area)

DRUGPrabotulinumtoxinA for Injection

cosmetic injection into the glabella area (eyebrow area)

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

blinding of participant and provider administering the treatment

Intervention model description

randomized controlled trial in which patients will be randomly assigned into one of four groups

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the Change in Dynamic Strain in the Glabella Area After Injection Over Timeday 3, day 30, day 90, day 180The 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

MeasureTime frameDescription
Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtimebaseline, day 3, day 30, day 90, day 180Correlation 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
OnabotulinumtoxinA
Botox Onabotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area)
35
AbobotulinumtoxinA
Dysport Abobotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area)
36
IncobotulinumtoxinA
Xeomin IncobotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area)
36
PrabotulinumtoxinA
Jeuveau PrabotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area)
36
Total143

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up7679

Baseline characteristics

CharacteristicOnabotulinumtoxinAAbobotulinumtoxinAIncobotulinumtoxinAPrabotulinumtoxinATotal
Age, Continuous45.5 years
STANDARD_DEVIATION 10.3
44.2 years
STANDARD_DEVIATION 9.5
42.5 years
STANDARD_DEVIATION 10.6
41.9 years
STANDARD_DEVIATION 8.9
43.5 years
STANDARD_DEVIATION 9.8
Race/Ethnicity, Customized
African American/Black
2 Participants3 Participants2 Participants0 Participants7 Participants
Race/Ethnicity, Customized
Asian
1 Participants3 Participants0 Participants2 Participants6 Participants
Race/Ethnicity, Customized
Declined to Answer
3 Participants0 Participants1 Participants1 Participants5 Participants
Race/Ethnicity, Customized
White/Caucasian
29 Participants30 Participants33 Participants33 Participants125 Participants
Sex: Female, Male
Female
35 Participants36 Participants36 Participants36 Participants143 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 360 / 360 / 36
other
Total, other adverse events
0 / 350 / 360 / 360 / 36
serious
Total, serious adverse events
0 / 350 / 360 / 360 / 36

Outcome results

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 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

Population: the change in dynamic strain is determined by measurements changes from two 3D images, if the images were not captured or the images were deemed unanalyzable then the population analyzed varies from the participant count.

ArmMeasureGroupValue (MEAN)Dispersion
OnabotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 36.4 percent difference of neutral+dyanamicStandard Deviation 5
OnabotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 308.6 percent difference of neutral+dyanamicStandard Deviation 5.4
OnabotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 904.5 percent difference of neutral+dyanamicStandard Deviation 4.6
OnabotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 1800.18 percent difference of neutral+dyanamicStandard Deviation 4.1
AbobotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 3010.6 percent difference of neutral+dyanamicStandard Deviation 6.2
AbobotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 905.7 percent difference of neutral+dyanamicStandard Deviation 5.2
AbobotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 1802.3 percent difference of neutral+dyanamicStandard Deviation 5.6
AbobotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 310.9 percent difference of neutral+dyanamicStandard Deviation 5.2
IncobotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 903.6 percent difference of neutral+dyanamicStandard Deviation 5.3
IncobotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 309.2 percent difference of neutral+dyanamicStandard Deviation 5.7
IncobotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 1802.6 percent difference of neutral+dyanamicStandard Deviation 4.7
IncobotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 36.6 percent difference of neutral+dyanamicStandard Deviation 5.6
PrabotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 1803.1 percent difference of neutral+dyanamicStandard Deviation 4.4
PrabotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 3010.4 percent difference of neutral+dyanamicStandard Deviation 4.3
PrabotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 38.9 percent difference of neutral+dyanamicStandard Deviation 4.6
PrabotulinumtoxinAthe Change in Dynamic Strain in the Glabella Area After Injection Over TimeDay 905.2 percent difference of neutral+dyanamicStandard Deviation 3.7
Secondary

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

Population: population of who answered the FACE-Q can be analyzed

ArmMeasureGroupValue (MEAN)Dispersion
OnabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 90-0.028 correlation coefficientStandard Error 0.087
OnabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 3-0.015 correlation coefficientStandard Error 0.031
OnabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 3-0.0870 correlation coefficientStandard Error 0.057
OnabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 180-0.086 correlation coefficientStandard Error 0.048
OnabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 180-0.053 correlation coefficientStandard Error 0.081
OnabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 1800.024 correlation coefficientStandard Error 0.041
OnabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 300.033 correlation coefficientStandard Error 0.492
OnabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 3-0.059 correlation coefficientStandard Error 0.086
OnabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 900.008 correlation coefficientStandard Error 0.053
OnabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 900.0327 correlation coefficientStandard Error 0.053
OnabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 300.025 correlation coefficientStandard Error 0.315
OnabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 300.015 correlation coefficientStandard Error 0.066
AbobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 90-0.012 correlation coefficientStandard Error 0.039
AbobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 30.046 correlation coefficientStandard Error 0.047
AbobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 90-0.042 correlation coefficientStandard Error 0.53
AbobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 3-0.013 correlation coefficientStandard Error 0.052
AbobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 180-0.010 correlation coefficientStandard Error 0.044
AbobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 300.075 correlation coefficientStandard Error 0.066
AbobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 30-0.018 correlation coefficientStandard Error 0.061
AbobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 180-0.065 correlation coefficientStandard Error 0.064
AbobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 1800.015 correlation coefficientStandard Error 0.069
AbobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 300.009 correlation coefficientStandard Error 0.045
AbobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 3-0.010 correlation coefficientStandard Error 83
AbobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 900.030 correlation coefficientStandard Error 0.04
IncobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 300.048 correlation coefficientStandard Error 0.047
IncobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 30.049 correlation coefficientStandard Error 0.661
IncobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 90-0.015 correlation coefficientStandard Error 0.046
IncobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 30-0.338 correlation coefficientStandard Error 0.055
IncobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 900.021 correlation coefficientStandard Error 0.053
IncobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 180-0.071 correlation coefficientStandard Error 0.0501
IncobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 30.033 correlation coefficientStandard Error 0.083
IncobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 30-0.002 correlation coefficientStandard Error 0.07
IncobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 900.015 correlation coefficientStandard Error 0.069
IncobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 180-0.031 correlation coefficientStandard Error 0.066
IncobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 30.064 correlation coefficientStandard Error 0.043
IncobotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 180-0.133 correlation coefficientStandard Error 0.041
PrabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 30-0.028 correlation coefficientStandard Error 0.041
PrabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 1800.034 correlation coefficientStandard Error 0.043
PrabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 3-0.038 correlation coefficientStandard Error 0.041
PrabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 3-0.059 correlation coefficientStandard Error 0.051
PrabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 180-0.014 correlation coefficientStandard Error 0.09
PrabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 90-0.039 correlation coefficientStandard Error 0.045
PrabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 300.027 correlation coefficientStandard Error 0.026
PrabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 30-0.0877 correlation coefficientStandard Error 0.046
PrabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines between Eyebrows Day 900.009 correlation coefficientStandard Error 0.028
PrabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeAppraisal of Lines: Forehead Day 3-0.095 correlation coefficientStandard Error 0.045
PrabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 1800.111 correlation coefficientStandard Error 0.063
PrabotulinumtoxinACorrelation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain OvertimeSatisfaction with Forehead Day 900.015 correlation coefficientStandard Error 0.069
p-value: 0.433Wilcoxon signed rank sum
p-value: 0.834Wilcoxon signed rank sum
p-value: 0.834Wilcoxon signed rank sum
p-value: 0.526Wilcoxon signed rank sum test
p-value: 0.13519Wilcoxon signed-rank sum test
p-value: 0.8556Wilcoxon signed-rank sum test
p-value: 0.46943Wilcoxon signed-rank test
p-value: 0.0449Wilcoxon signed-rank sum test
p-value: 0.504Wilcoxon signed-rank sum test
p-value: 0.772193Wilcoxon signed-rank sum test
p-value: 0.5414Wilcoxon signed-rank sum test
p-value: 0.07Wilcoxon signed-rank sum test
p-value: 0.546Wilcoxon signed rank sum test
p-value: 0.756Wilcoxon signed rank sum test
p-value: 0.7Wilcoxon signed rank sum test
p-value: 0.397Wilcoxon signed rank sum
p-value: 0.093Wilcoxon signed rank sum
p-value: 0.323Wilcoxon signed rank sum
p-value: 0.182Wilcoxon signed rank sum
p-value: 0.88Wilcoxon signed rank sum
p-value: 0.496Wilcoxon signed rank sum
p-value: 0.905Wilcoxon signed rank sum
p-value: 0.692Wilcoxon signed rank sum
p-value: 0.262Wilcoxon signed rank sum
p-value: 0.828Wilcoxon signed rank sum
p-value: 0.268Wilcoxon signed rank sum test
p-value: 0.975Wilcoxon signed rank sum
p-value: 0.499Wilcoxon signed rank sum
p-value: 0.75Wilcoxon signed rank sum
p-value: 0.816Wilcoxon singed rank sum
p-value: 0.65wilcoxon signed rank sum
p-value: 0.095wilcoxon rank sum test
p-value: 0.618Wilcoxon signed rank sum
p-value: 0.34wilcoxon signed rank sum
p-value: 0.15Wilcoxon signed rank sum
p-value: 0.361Wilcoxon signed rank sum test
p-value: 0.428wilcoxon signed rank sum
p-value: 0.834Wilcoxon signed rank sum
p-value: 0.318wilcoxon signed rank sum
p-value: 0.311wilcoxon signed rank sum
p-value: 0.885Wilcoxon signed rank sum
p-value: 0.457Wilcoxon signed rank sum
p-value: 0.745Wilcoxon signed rank sum
p-value: 0.757wilcoxon signed rank sum
p-value: 0.562wilcoxon signed rank sum
p-value: 0.828wilcoxon signed rank sum
p-value: 0.005wilcoxon signed rank sum
p-value: 0.437wilcoxon signed rank sum

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026