Combination Facial Aesthetic Treatment in Millennials
Condition: Dermatological Non-Disease
Intervention: Botox Cosmetic Injectable Product; Juvéderm Voluma XC; Juvéderm Volbella XC
Intervention description: Acetylcholine release inhibitor and a neuromuscular blocking agent; Gel implants consisting of cross-linked hyaluronic acid; Gel implants consisting of cross-linked hyaluronic acid
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
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.
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 24 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        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