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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA | Active Comparator | Botox |
|
| AbobotulinumtoxinA | Active Comparator | Dysport |
|
| IncobotulinumtoxinA | Active Comparator | Xeomin |
|
| PrabotulinumtoxinA | Active Comparator | Jeuveau |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onabotulinumtoxina for Injection | Drug | cosmetic injection into the glabella area (eyebrow area) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 3, day 30, day 90, day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, day 3, day 30, day 90, day 180 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40434770 | Derived | Lemdani MS, Honig SE, Habarth-Morales TE, Davis HD, Niu EF, Ewing JN, Broach RB, Serletti JM, Percec I. Comparison of Botulinum Toxin A Formulations for Glabellar Strain Treatment in Women: A Double-Blind Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 1;161(7):723-730. doi: 10.1001/jamadermatol.2025.1335. |
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| ID | Title | Description |
|---|---|---|
| FG000 | OnabotulinumtoxinA | Botox Onabotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area) |
| FG001 | AbobotulinumtoxinA | Dysport Abobotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area) |
| FG002 | IncobotulinumtoxinA | Xeomin IncobotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area) |
| FG003 | PrabotulinumtoxinA | Jeuveau PrabotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OnabotulinumtoxinA | Botox Onabotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area) |
| BG001 | AbobotulinumtoxinA | Dysport Abobotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | percent difference of neutral+dyanamic | day 3, day 30, day 90, day 180 |
|
180 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OnabotulinumtoxinA | Botox Onabotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ivona Percec, PhD, MD | University of Pennsylvania | 215-662-7300 | ivona.percec@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2020 | May 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D007267 | Injections |
| C542869 | abobotulinumtoxinA |
| C545476 | incobotulinumtoxinA |
| C000630868 | prabotulinumtoxin A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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randomized controlled trial in which patients will be randomly assigned into one of four groups
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blinding of participant and provider administering the treatment
| Abobotulinumtoxina for Injection | Drug | cosmetic injection into the glabella area (eyebrow area) |
|
|
| IncobotulinumtoxinA for Injection | Drug | cosmetic injection into the glabella area (eyebrow area) |
|
|
| PrabotulinumtoxinA for Injection | Drug | cosmetic injection into the glabella area (eyebrow area) |
|
|
| BG002 | IncobotulinumtoxinA | Xeomin IncobotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area) |
| BG003 | PrabotulinumtoxinA | Jeuveau PrabotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Botox
Onabotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area)
| OG001 | AbobotulinumtoxinA | Dysport Abobotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area) |
| OG002 | IncobotulinumtoxinA | Xeomin IncobotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area) |
| OG003 | PrabotulinumtoxinA | Jeuveau PrabotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area) |
|
|
| 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. | population of who answered the FACE-Q can be analyzed | Posted | Mean | Standard Error | correlation coefficient | baseline, day 3, day 30, day 90, day 180 |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | AbobotulinumtoxinA | Dysport Abobotulinumtoxina for Injection: cosmetic injection into the glabella area (eyebrow area) | 0 | 36 | 0 | 36 | 0 | 36 |
| EG002 | IncobotulinumtoxinA | Xeomin IncobotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area) | 0 | 36 | 0 | 36 | 0 | 36 |
| EG003 | PrabotulinumtoxinA | Jeuveau PrabotulinumtoxinA for Injection: cosmetic injection into the glabella area (eyebrow area) | 0 | 36 | 0 | 36 | 0 | 36 |
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| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| Appraisal of Lines: Forehead Day 30 |
|
| Appraisal of Lines: Forehead Day 90 |
|
| Appraisal of Lines: Forehead Day 180 |
|
| Satisfaction with Forehead Day 3 |
|
| Satisfaction with Forehead Day 30 |
|
| Satisfaction with Forehead Day 90 |
|
| Satisfaction with Forehead Day 180 |
|
| Appraisal of Lines between Eyebrows Day 3 |
|
| Appraisal of Lines between Eyebrows Day 30 |
|
| Appraisal of Lines between Eyebrows Day 90 |
|
| Appraisal of Lines between Eyebrows Day 180 |
|
| 0.8556 |
| 2-Sided |
| 95 |
| Superiority |
the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3 |
| Wilcoxon signed-rank test | 0.46943 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3 |
| Wilcoxon signed-rank sum test | 0.0449 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3 |
| Wilcoxon signed-rank sum test | 0.504 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30 |
| Wilcoxon signed-rank sum test | 0.772193 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30 |
| Wilcoxon signed-rank sum test | 0.5414 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30 |
| Wilcoxon signed-rank sum test | 0.070 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30 |
| Wilcoxon signed rank sum test | 0.546 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90 |
| Wilcoxon signed rank sum test | 0.756 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90 |
| Wilcoxon signed rank sum test | 0.700 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90 |
| Wilcoxon signed rank sum | 0.397 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90 |
| Wilcoxon signed rank sum | 0.093 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180 |
| Wilcoxon signed rank sum | 0.323 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180 |
| Wilcoxon signed rank sum | 0.182 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) tothe patient satisfaction improvement of line in the forehead post injection day 180 |
| Wilcoxon signed rank sum | 0.880 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180 |
| Wilcoxon signed rank sum | 0.496 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) tothe patient satisfaction improvement in the forehead post injection day 3 |
| Wilcoxon signed rank sum | 0.905 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3 |
| Wilcoxon signed rank sum | 0.692 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3 |
| Wilcoxon signed rank sum | 0.262 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3 |
| Wilcoxon signed rank sum | 0.828 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30 |
| Wilcoxon signed rank sum test | 0.268 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30 |
| Wilcoxon signed rank sum | 0.975 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30 |
| Wilcoxon signed rank sum | 0.499 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30 |
| Wilcoxon signed rank sum | 0.750 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90 |
| Wilcoxon signed rank sum | 0.433 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90 |
| Wilcoxon signed rank sum | 0.834 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90 |
| Wilcoxon signed rank sum | 0.834 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90 |
| Wilcoxon signed rank sum test | 0.526 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180 |
| Wilcoxon singed rank sum | 0.816 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180 |
| wilcoxon signed rank sum | 0.650 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180 |
| wilcoxon rank sum test | 0.095 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180 |
| Wilcoxon signed rank sum | 0.618 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3 |
| wilcoxon signed rank sum | 0.340 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3 |
| Wilcoxon signed rank sum | 0.150 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3 |
| Wilcoxon signed rank sum test | 0.361 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3 |
| wilcoxon signed rank sum | 0.428 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30 |
| Wilcoxon signed rank sum | 0.834 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30 |
| wilcoxon signed rank sum | 0.318 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30 |
| wilcoxon signed rank sum | 0.311 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30 |
| Wilcoxon signed rank sum | 0.885 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90 |
| Wilcoxon signed rank sum | 0.457 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90 |
| Wilcoxon signed rank sum | 0.745 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90 |
| wilcoxon signed rank sum | 0.757 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90 |
| wilcoxon signed rank sum | 0.562 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180 |
| wilcoxon signed rank sum | 0.828 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180 |
| wilcoxon signed rank sum | 0.005 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180 |
| wilcoxon signed rank sum | 0.437 | 2-Sided | 95 | Superiority | the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180 |