Cosmetic Techniques
Conditions
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)
cosmetic injection into the glabella area (eyebrow area)
cosmetic injection into the glabella area (eyebrow area)
cosmetic injection into the glabella area (eyebrow area)
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 6 | 7 | 9 |
Baseline characteristics
| Characteristic | OnabotulinumtoxinA | AbobotulinumtoxinA | IncobotulinumtoxinA | PrabotulinumtoxinA | Total |
|---|---|---|---|---|---|
| Age, Continuous | 45.5 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 Participants | 3 Participants | 2 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Declined to Answer | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized White/Caucasian | 29 Participants | 30 Participants | 33 Participants | 33 Participants | 125 Participants |
| Sex: Female, Male Female | 35 Participants | 36 Participants | 36 Participants | 36 Participants | 143 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 36 | 0 / 36 | 0 / 36 |
| other Total, other adverse events | 0 / 35 | 0 / 36 | 0 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 35 | 0 / 36 | 0 / 36 | 0 / 36 |
Outcome results
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OnabotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 3 | 6.4 percent difference of neutral+dyanamic | Standard Deviation 5 |
| OnabotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 30 | 8.6 percent difference of neutral+dyanamic | Standard Deviation 5.4 |
| OnabotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 90 | 4.5 percent difference of neutral+dyanamic | Standard Deviation 4.6 |
| OnabotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 180 | 0.18 percent difference of neutral+dyanamic | Standard Deviation 4.1 |
| AbobotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 30 | 10.6 percent difference of neutral+dyanamic | Standard Deviation 6.2 |
| AbobotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 90 | 5.7 percent difference of neutral+dyanamic | Standard Deviation 5.2 |
| AbobotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 180 | 2.3 percent difference of neutral+dyanamic | Standard Deviation 5.6 |
| AbobotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 3 | 10.9 percent difference of neutral+dyanamic | Standard Deviation 5.2 |
| IncobotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 90 | 3.6 percent difference of neutral+dyanamic | Standard Deviation 5.3 |
| IncobotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 30 | 9.2 percent difference of neutral+dyanamic | Standard Deviation 5.7 |
| IncobotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 180 | 2.6 percent difference of neutral+dyanamic | Standard Deviation 4.7 |
| IncobotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 3 | 6.6 percent difference of neutral+dyanamic | Standard Deviation 5.6 |
| PrabotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 180 | 3.1 percent difference of neutral+dyanamic | Standard Deviation 4.4 |
| PrabotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 30 | 10.4 percent difference of neutral+dyanamic | Standard Deviation 4.3 |
| PrabotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 3 | 8.9 percent difference of neutral+dyanamic | Standard Deviation 4.6 |
| PrabotulinumtoxinA | the Change in Dynamic Strain in the Glabella Area After Injection Over Time | Day 90 | 5.2 percent difference of neutral+dyanamic | Standard Deviation 3.7 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OnabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 90 | -0.028 correlation coefficient | Standard Error 0.087 |
| OnabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 3 | -0.015 correlation coefficient | Standard Error 0.031 |
| OnabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 3 | -0.0870 correlation coefficient | Standard Error 0.057 |
| OnabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 180 | -0.086 correlation coefficient | Standard Error 0.048 |
| OnabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 180 | -0.053 correlation coefficient | Standard Error 0.081 |
| OnabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 180 | 0.024 correlation coefficient | Standard Error 0.041 |
| OnabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 30 | 0.033 correlation coefficient | Standard Error 0.492 |
| OnabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 3 | -0.059 correlation coefficient | Standard Error 0.086 |
| OnabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 90 | 0.008 correlation coefficient | Standard Error 0.053 |
| OnabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 90 | 0.0327 correlation coefficient | Standard Error 0.053 |
| OnabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 30 | 0.025 correlation coefficient | Standard Error 0.315 |
| OnabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 30 | 0.015 correlation coefficient | Standard Error 0.066 |
| AbobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 90 | -0.012 correlation coefficient | Standard Error 0.039 |
| AbobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 3 | 0.046 correlation coefficient | Standard Error 0.047 |
| AbobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 90 | -0.042 correlation coefficient | Standard Error 0.53 |
| AbobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 3 | -0.013 correlation coefficient | Standard Error 0.052 |
| AbobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 180 | -0.010 correlation coefficient | Standard Error 0.044 |
| AbobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 30 | 0.075 correlation coefficient | Standard Error 0.066 |
| AbobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 30 | -0.018 correlation coefficient | Standard Error 0.061 |
| AbobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 180 | -0.065 correlation coefficient | Standard Error 0.064 |
| AbobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 180 | 0.015 correlation coefficient | Standard Error 0.069 |
| AbobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 30 | 0.009 correlation coefficient | Standard Error 0.045 |
| AbobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 3 | -0.010 correlation coefficient | Standard Error 83 |
| AbobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 90 | 0.030 correlation coefficient | Standard Error 0.04 |
| IncobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 30 | 0.048 correlation coefficient | Standard Error 0.047 |
| IncobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 3 | 0.049 correlation coefficient | Standard Error 0.661 |
| IncobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 90 | -0.015 correlation coefficient | Standard Error 0.046 |
| IncobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 30 | -0.338 correlation coefficient | Standard Error 0.055 |
| IncobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 90 | 0.021 correlation coefficient | Standard Error 0.053 |
| IncobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 180 | -0.071 correlation coefficient | Standard Error 0.0501 |
| IncobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 3 | 0.033 correlation coefficient | Standard Error 0.083 |
| IncobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 30 | -0.002 correlation coefficient | Standard Error 0.07 |
| IncobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 90 | 0.015 correlation coefficient | Standard Error 0.069 |
| IncobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 180 | -0.031 correlation coefficient | Standard Error 0.066 |
| IncobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 3 | 0.064 correlation coefficient | Standard Error 0.043 |
| IncobotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 180 | -0.133 correlation coefficient | Standard Error 0.041 |
| PrabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 30 | -0.028 correlation coefficient | Standard Error 0.041 |
| PrabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 180 | 0.034 correlation coefficient | Standard Error 0.043 |
| PrabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 3 | -0.038 correlation coefficient | Standard Error 0.041 |
| PrabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 3 | -0.059 correlation coefficient | Standard Error 0.051 |
| PrabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 180 | -0.014 correlation coefficient | Standard Error 0.09 |
| PrabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 90 | -0.039 correlation coefficient | Standard Error 0.045 |
| PrabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 30 | 0.027 correlation coefficient | Standard Error 0.026 |
| PrabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 30 | -0.0877 correlation coefficient | Standard Error 0.046 |
| PrabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines between Eyebrows Day 90 | 0.009 correlation coefficient | Standard Error 0.028 |
| PrabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Appraisal of Lines: Forehead Day 3 | -0.095 correlation coefficient | Standard Error 0.045 |
| PrabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 180 | 0.111 correlation coefficient | Standard Error 0.063 |
| PrabotulinumtoxinA | Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime | Satisfaction with Forehead Day 90 | 0.015 correlation coefficient | Standard Error 0.069 |