Combination Facial Aesthetic Treatment in Millennials

Study Overview
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Brief Summary
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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.

Detailed Description
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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 (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).

Official Title
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Combination Facial Aesthetic Treatment in Millennials

Conditions
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Dermatological Non-Disease

Intervention / Treatment
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* Drug: Botox Cosmetic Injectable Product
* Device: Juvéderm Voluma XC
* Device: Juvéderm Volbella XC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facial aesthetic treatment<br>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. | Drug: Botox Cosmetic Injectable Product<br>* Acetylcholine release inhibitor and a neuromuscular blocking agent<br>* Other names: onabotulinumtoxinA;Device: Juvéderm Voluma XC<br>* Gel implants consisting of cross-linked hyaluronic acid<br>Device: Juvéderm Volbella XC<br>* Gel implants consisting of cross-linked hyaluronic acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in FACE-Q Satisfaction With Facial Appearance Overall Scale | To evaluate 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. | 2 months after the procedure compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess 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 several 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. | At baseline | 
| Changes in 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 several 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. | 2 months after the procedure compared to baseline | 
| Changes in 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. This study participant will select 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. | 2 months after the procedure compared to baseline | 
| Changes in FACE-Q Aesthetic Scales | To assess changes in patient satisfaction with their appearance after facial aesthetic treatment, using the FACE-Q Aesthetic Scales. The tool consists of several questions regarding self-perception of facial features. For questions regarding facial lines, study participants select a number from 1 to 4, with higher numbers reflecting more bothersome lines. For questions regarding cheeks and lips, study participants select a number from 1 to 4, with higher numbers reflecting greater satisfaction with cheeks and lips. | 2 months after the procedure compared to baseline | 
| Assess 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 several 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. | 2 months after the procedure | 
| Changes in FACE-Q Psychological Function Scale | To assess changes in psychosocial factors after facial aesthetic treatment, using and FACE-Q Psychological Function Scale. This tool consists of several 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. | 2 months after the procedure compared to baseline | 
| Changes in 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 several 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. | 2 months after the procedure compared to baseline |