Dermatological Non-Disease
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DRUGBotox Cosmetic Injectable Product
Acetylcholine release inhibitor and a neuromuscular blocking agent
DEVICEJuvéderm Voluma XC
Gel implants consisting of cross-linked hyaluronic acid
DEVICEJuvéderm Volbella XC
Gel implants consisting of cross-linked hyaluronic acid
Sponsors
Allergan Sales, LLC
State University of New York - Downstate Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
24 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Date of birth between January 1, 1981 and December 31, 1996 * Naiveté to facial injections of botulinum toxin and dermal filler * Desire to receive all three facial cosmetic injectables in the study * Suitable candidate to receive facial injectables, as determined by clinician judgment * Provision of written informed consent for all study procedures * Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion criteria
* Desire to receive only one or two of the facial injectables * Dermatologic or medical conditions at the injection sites that may be exacerbated by the study procedures (e.g., severe acne, active infection, open sores or lesions, history of cold sores) * Pre-existing cardiovascular disease (e.g., heart failure, coronary artery disease) * Pre-existing swallowing or respiratory disorders (e.g., dysphagia, asthma, COPD) * Peripheral motor neuropathy disease, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome) * Known hypersensitivity or allergies to any of the components of the administered drugs/devices in the study (e.g., Gram-positive bacterial proteins, lidocaine) * History of anaphylaxis or multiple severe allergies * History of a bleeding or coagulation disorder * Pregnant or breast-feeding * Current and/or scheduled use of the following medications: immunosuppressants, anticoagulants (e.g., warfarin, heparin, rivaroxaban), antiplatelets (e.g., clopidogrel, ticagrelor, NSAIDs), antibiotics (e.g., aminoglycosides), anticholinergics, muscle relaxants * Procedures or treatments to the face in the past 14 days (e.g., chemical peel, laser surgery, microdermabrasion) * Plan to undergo elective cosmetic procedure on the face (e.g., laser surgery, plastic surgery, physician-strength chemical peel) during the study * Any medical condition(s) that could be compromised by participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FACE-Q Satisfaction With Facial Appearance Overall Scale | Baseline and 2 months after the procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FACE-Q Expectations Scale | At baseline | 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. |
| FACE-Q Social Function Scale | Baseline and 2 months after the procedure | 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. |
| FACE-Q Patient-Perceived Age Visual Analogue Scale | Baseline and 2 months after the procedure | 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. |
| FACE-Q Satisfaction With Cheeks | Baseline and 2 months after the procedure | 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. |
| FACE-Q Appraisal of Lines Overall | Baseline and 2 months after the procedure | 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. |
| FACE-Q Psychological Function Scale | Baseline and 2 months after the procedure | 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. |
| FACE-Q Aging Appraisal Scale | 2 months after the procedure compared to baseline | 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. |
| FACE-Q Satisfaction With Lips | Baseline and 2 months after the procedure | 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. |
| FACE-Q Satisfaction With Outcome Scale | 2 months after the procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Facial Aesthetic Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 29.8 years STANDARD_DEVIATION 4.2 |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Two or more races | 2 Participants |
| Race/Ethnicity, Customized White, Hispanic | 2 Participants |
| Race/Ethnicity, Customized White, Non-Hispanic | 13 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 17 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: Baseline and 2 months after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | FACE-Q Satisfaction With Facial Appearance Overall Scale | 42.35 score on a scale | Standard Deviation 8.94 |
| Post-treatment | FACE-Q Satisfaction With Facial Appearance Overall Scale | 59.42 score on a scale | Standard Deviation 15.08 |
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.
Time frame: 2 months after the procedure compared to baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | FACE-Q Aging Appraisal Scale | 12.6 score on a scale | Standard Deviation 5.6 |
| Post-treatment | FACE-Q Aging Appraisal Scale | 9.8 score on a scale | Standard Deviation 4.8 |
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.
Time frame: Baseline and 2 months after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | FACE-Q Appraisal of Lines Overall | 21.5 score on a scale | Standard Deviation 6.8 |
| Post-treatment | FACE-Q Appraisal of Lines Overall | 15.1 score on a scale | Standard Deviation 3.2 |
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.
Time frame: At baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | FACE-Q Expectations Scale | 17.4 score on a scale | Standard Deviation 4.6 |
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.
Time frame: Baseline and 2 months after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | FACE-Q Patient-Perceived Age Visual Analogue Scale | 0.2 score on a scale | Standard Deviation 2.3 |
| Post-treatment | FACE-Q Patient-Perceived Age Visual Analogue Scale | -2.2 score on a scale | Standard Deviation 3.1 |
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.
Time frame: Baseline and 2 months after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | FACE-Q Psychological Function Scale | 30.5 score on a scale | Standard Deviation 8.2 |
| Post-treatment | FACE-Q Psychological Function Scale | 34.9 score on a scale | Standard Deviation 5.1 |
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.
Time frame: Baseline and 2 months after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | FACE-Q Satisfaction With Cheeks | 13.3 score on a scale | Standard Deviation 3.4 |
| Post-treatment | FACE-Q Satisfaction With Cheeks | 16.9 score on a scale | Standard Deviation 2.1 |
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.
Time frame: Baseline and 2 months after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | FACE-Q Satisfaction With Lips | 25.4 score on a scale | Standard Deviation 7.3 |
| Post-treatment | FACE-Q Satisfaction With Lips | 34.9 score on a scale | Standard Deviation 4.4 |
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.
Time frame: 2 months after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | FACE-Q Satisfaction With Outcome Scale | 20.8 score on a scale | Standard Deviation 2.9 |
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.
Time frame: Baseline and 2 months after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | FACE-Q Social Function Scale | 24.4 score on a scale | Standard Deviation 4.6 |
| Post-treatment | FACE-Q Social Function Scale | 27.4 score on a scale | Standard Deviation 4.3 |