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| Name | Class |
|---|---|
| Allergan Sales, LLC | INDUSTRY |
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With 63% of consumers willing to consider investing in facial aesthetics and 73% of consumers worldwide expecting to invest in aesthetic treatments in the upcoming year, it is imperative to explore patient satisfaction and psychosocial impact of a multimodal aesthetic treatment in a millennial cohort. The investigators hypothesize that a combination approach to facial aesthetic treatment in a millennial cohort will result in increased patient-reported satisfaction in multiple areas, including perception of aging concerns and quality of life.
This is a single-center, prospective, rater-blinded, pilot study to evaluate patient satisfaction with facial aesthetic treatment using a combination of botulinum toxin and dermal fillers. The three types of injectables are Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler). Twenty individuals who belong to the millennial generation (i.e., born between January 1, 1981 and December 31, 1996)1 and meet eligibility criteria will be enrolled. Study participants will receive all three injectables during a single procedure, with an optional touch-up treatment at 2 weeks. The primary endpoint is the change in satisfaction after facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale. Other outcome measures include various FACE-Q Aesthetic scales, digital skin imaging analysis, photographs, and rater-blinded clinical assessment using the Global Aesthetic Improvement Scale (GAIS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facial aesthetic treatment | Experimental | Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox Cosmetic Injectable Product | Drug | Acetylcholine release inhibitor and a neuromuscular blocking agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| FACE-Q Satisfaction With Facial Appearance Overall Scale | To assess changes in patient's satisfaction with their appearance following a combination facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale. This tool consists of several questions. For each question, the study participant selects a number from 1 to 4. Higher number are associated with higher satisfaction with facial appearance. The raw scores of the primary outcome measure were transformed by the Rasch measurement method into a 0-to-100 point scale. | Baseline and 2 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| FACE-Q Appraisal of Lines Overall | To assess changes in patient dissatisfaction with the appearance of overall facial lines, using the FACE-Q Appraisal of Lines: Overall Scale. The tool consists of ten questions regarding self-perception of overall facial lines. For each question, study participants select a number from 1 to 4, with higher numbers reflecting greater dissatisfaction with facial lines. The total score is tallied. The minimum total score is 10 and the maximum total score is 40. A higher total score is associated with greater dissatisfaction with facial lines. The mean total score at baseline and 2 months post procedure are reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared Jagdeo, MD, MS | SUNY Downstate Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Downstate Health Sciences University | Brooklyn | New York | 11203 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Facial Aesthetic Treatment | Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks. Botox Cosmetic Injectable Product: Acetylcholine release inhibitor and a neuromuscular blocking agent Juvéderm Voluma XC: Gel implants consisting of cross-linked hyaluronic acid Juvéderm Volbella XC: Gel implants consisting of cross-linked hyaluronic acid |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Facial Aesthetic Treatment | Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks. Botox Cosmetic Injectable Product: Acetylcholine release inhibitor and a neuromuscular blocking agent Juvéderm Voluma XC: Gel implants consisting of cross-linked hyaluronic acid Juvéderm Volbella XC: Gel implants consisting of cross-linked hyaluronic acid |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | FACE-Q Satisfaction With Facial Appearance Overall Scale | To assess changes in patient's satisfaction with their appearance following a combination facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale. This tool consists of several questions. For each question, the study participant selects a number from 1 to 4. Higher number are associated with higher satisfaction with facial appearance. The raw scores of the primary outcome measure were transformed by the Rasch measurement method into a 0-to-100 point scale. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 months after the procedure |
|
Adverse events were collected over two months.
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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 | Facial Aesthetic Treatment | Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks. Botox Cosmetic Injectable Product: Acetylcholine release inhibitor and a neuromuscular blocking agent Juvéderm Voluma XC: Gel implants consisting of cross-linked hyaluronic acid Juvéderm Volbella XC: Gel implants consisting of cross-linked hyaluronic acid |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jared Jagdeo MD, MS | SUNY Downstate Health Sciences University | (718) 270-1229 | jared.jagdeo@downstate.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 | Feb 25, 2020 | Aug 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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This is a single-center, prospective, rater-blinded, pilot study to evaluate patient satisfaction with facial aesthetic treatment using a combination of botulinum toxin and dermal fillers. The three types of injectables are Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler). Twenty individuals who belong to the millennial generation and meet eligibility criteria will be enrolled. Study participants will receive all three injectables during a single procedure. The primary endpoint is the change in satisfaction after facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale.
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| Juvéderm Voluma XC | Device | Gel implants consisting of cross-linked hyaluronic acid |
|
| Juvéderm Volbella XC | Device | Gel implants consisting of cross-linked hyaluronic acid |
|
| Baseline and 2 months after the procedure |
| FACE-Q Expectations Scale | To assess patient expectations regarding the impact of facial aesthetic treatment on their lives, using the FACE-Q Expectations Scale. This tool consists of eight statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score of the statements is tallied. The minimum total score is 8 and the maximum total score is 32. The higher the total score, the greater positive impact the participants believe the treatments will have on their lives. The mean total score at baseline is reported. | At baseline |
| FACE-Q Social Function Scale | To assess changes in psychosocial factors after facial aesthetic treatment, using FACE-Q Social Function Scale. This tool consists of eight statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score of the statements is tallied for each patient. The minimum total score is 8 and the maximum total score is 32. A higher total score reflects greater social functioning. The mean total score is reported at baseline and 2 months after the procedure. | Baseline and 2 months after the procedure |
| FACE-Q Patient-Perceived Age Visual Analogue Scale | To assess changes in self-perceived age after facial aesthetic treatment, using the FACE-Q Patient-Perceived Age Visual Analogue Scale. The study participant selects a number on the scale from -15 to +15. 0 corresponds to "I look my age". -15 corresponds to "I look 15 years younger". +15 corresponds to "I look 15 years older". The mean score at baseline and 2 months post procedure are reported. | Baseline and 2 months after the procedure |
| FACE-Q Satisfaction With Cheeks | To assess changes in patient satisfaction with the appearance of their cheeks after facial aesthetic treatment, using the FACE-Q Satisfaction with Cheeks Scale. The tool consists of five questions regarding self-perception of cheeks. For each question, study participants select a number from 1 to 4, with higher numbers reflecting greater satisfaction with cheeks. The total score is tallied. The minimum total score is 5 and the maximum total score is 20. A higher total score is associated with greater satisfaction with cheeks. The mean total score at baseline and 2 months post procedure are reported. | Baseline and 2 months after the procedure |
| FACE-Q Satisfaction With Outcome Scale | To assess patient satisfaction with facial aesthetic treatment, using the FACE-Q Satisfaction with Outcome Scale. This tool consists of six statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score is tallied. The minimum total score is 6 and the maximum total score is 24. A higher total score is associated with greater satisfaction with outcome. The mean total score 2 months after the procedure is reported. | 2 months after the procedure |
| FACE-Q Psychological Function Scale | To assess changes in psychosocial factors after facial aesthetic treatment, using the FACE-Q Psychological Function Scale. This tool consists of ten statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score is tallied. The minimum total score is 10 and the maximum total score is 40. A higher total score is associated with better psychological functioning. The mean total score at baseline and 2 months after the procedure are reported. | Baseline and 2 months after the procedure |
| FACE-Q Aging Appraisal Scale | To assess changes in self-perceived age after facial aesthetic treatment, using the FACE-Q Aging Appraisal Scale. This tool consists of seven statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score is tallied. The minimum total score is 7 and the maximum total score is 28. A lower total score is associated with greater satisfaction with self-perceived age. The mean total score at baseline and 2 months after the procedure are reported. | 2 months after the procedure compared to baseline |
| FACE-Q Satisfaction With Lips | To assess changes in patient satisfaction with the appearance of their lips after facial aesthetic treatment, using the FACE-Q Satisfaction with Lips Scale. The tool consists of ten questions regarding self-perception of lips. For each question, study participants select a number from 1 to 4, with higher numbers reflecting greater satisfaction with lips. The total score is tallied. The minimum total score is 10 and the maximum total score is 40. A higher total score is associated with greater satisfaction with lips. The mean total score at baseline and 2 months post procedure are reported. | Baseline and 2 months after the procedure |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Post-treatment assessment of satisfaction of overall facial appearance (conducted 2 months post-combination facial aesthetic treatment using soft tissue fillers and botulinum toxin). |
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| Secondary | FACE-Q Appraisal of Lines Overall | To assess changes in patient dissatisfaction with the appearance of overall facial lines, using the FACE-Q Appraisal of Lines: Overall Scale. The tool consists of ten questions regarding self-perception of overall facial lines. For each question, study participants select a number from 1 to 4, with higher numbers reflecting greater dissatisfaction with facial lines. The total score is tallied. The minimum total score is 10 and the maximum total score is 40. A higher total score is associated with greater dissatisfaction with facial lines. The mean total score at baseline and 2 months post procedure are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 months after the procedure |
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| Secondary | FACE-Q Expectations Scale | To assess patient expectations regarding the impact of facial aesthetic treatment on their lives, using the FACE-Q Expectations Scale. This tool consists of eight statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score of the statements is tallied. The minimum total score is 8 and the maximum total score is 32. The higher the total score, the greater positive impact the participants believe the treatments will have on their lives. The mean total score at baseline is reported. | Posted | Mean | Standard Deviation | score on a scale | At baseline |
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| Secondary | FACE-Q Social Function Scale | To assess changes in psychosocial factors after facial aesthetic treatment, using FACE-Q Social Function Scale. This tool consists of eight statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score of the statements is tallied for each patient. The minimum total score is 8 and the maximum total score is 32. A higher total score reflects greater social functioning. The mean total score is reported at baseline and 2 months after the procedure. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 months after the procedure |
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| Secondary | FACE-Q Patient-Perceived Age Visual Analogue Scale | To assess changes in self-perceived age after facial aesthetic treatment, using the FACE-Q Patient-Perceived Age Visual Analogue Scale. The study participant selects a number on the scale from -15 to +15. 0 corresponds to "I look my age". -15 corresponds to "I look 15 years younger". +15 corresponds to "I look 15 years older". The mean score at baseline and 2 months post procedure are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 months after the procedure |
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| Secondary | FACE-Q Satisfaction With Cheeks | To assess changes in patient satisfaction with the appearance of their cheeks after facial aesthetic treatment, using the FACE-Q Satisfaction with Cheeks Scale. The tool consists of five questions regarding self-perception of cheeks. For each question, study participants select a number from 1 to 4, with higher numbers reflecting greater satisfaction with cheeks. The total score is tallied. The minimum total score is 5 and the maximum total score is 20. A higher total score is associated with greater satisfaction with cheeks. The mean total score at baseline and 2 months post procedure are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 months after the procedure |
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| Secondary | FACE-Q Satisfaction With Outcome Scale | To assess patient satisfaction with facial aesthetic treatment, using the FACE-Q Satisfaction with Outcome Scale. This tool consists of six statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score is tallied. The minimum total score is 6 and the maximum total score is 24. A higher total score is associated with greater satisfaction with outcome. The mean total score 2 months after the procedure is reported. | Posted | Mean | Standard Deviation | score on a scale | 2 months after the procedure |
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| Secondary | FACE-Q Psychological Function Scale | To assess changes in psychosocial factors after facial aesthetic treatment, using the FACE-Q Psychological Function Scale. This tool consists of ten statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score is tallied. The minimum total score is 10 and the maximum total score is 40. A higher total score is associated with better psychological functioning. The mean total score at baseline and 2 months after the procedure are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 months after the procedure |
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| Secondary | FACE-Q Aging Appraisal Scale | To assess changes in self-perceived age after facial aesthetic treatment, using the FACE-Q Aging Appraisal Scale. This tool consists of seven statements. For each statement, the study participant selects a number from 1 to 4, where 1 represents "definitely disagree", 2 represents "somewhat disagree", 3 represents "somewhat agree", and 4 represents "definitely agree". The total score is tallied. The minimum total score is 7 and the maximum total score is 28. A lower total score is associated with greater satisfaction with self-perceived age. The mean total score at baseline and 2 months after the procedure are reported. | Posted | Mean | Standard Deviation | score on a scale | 2 months after the procedure compared to baseline |
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| Secondary | FACE-Q Satisfaction With Lips | To assess changes in patient satisfaction with the appearance of their lips after facial aesthetic treatment, using the FACE-Q Satisfaction with Lips Scale. The tool consists of ten questions regarding self-perception of lips. For each question, study participants select a number from 1 to 4, with higher numbers reflecting greater satisfaction with lips. The total score is tallied. The minimum total score is 10 and the maximum total score is 40. A higher total score is associated with greater satisfaction with lips. The mean total score at baseline and 2 months post procedure are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 months after the procedure |
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| 0 |
| 20 |
| 0 |
| 20 |
| 17 |
| 20 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Soreness | General disorders | Systematic Assessment |
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| Lumps localized to midface dermal filler injection sites | Skin and subcutaneous tissue disorders | Systematic Assessment |
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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 |