A Study to Evaluate Participant Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment
Condition: Facial Rhytides, Skin Folds, Loss of Volume and Skin Quality
MeSH terms: Facies
Intervention: JUVÉDERM®; BOTOX Cosmetic®; BELKYRA®; SkinMedica
Intervention description: Facial filler injection (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8 (BELKYRA Treatment) and Month 0 to Month 2 (Non-BELKYRA Treatment).; BOTOX Cosmetic, 20 U to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U injected to forehead lines at Month 9 and Month 10 (BELKYRA Treatment) and at Month 3 and Month 4 (Non-BELKYRA Treatment).; BELKYRA, subcutaneous injection for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose = 100 mg (10mL).; SkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11 (BELKYRA Treatment) and Month 0 to Month 5 (Non-BELKYRA Treatment).
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The objective of this study is to quantify the psychological and emotional impact of
      comprehensive aesthetic treatment with a portfolio of Allergan products by measuring the
      change in participant's satisfaction with facial appearance from baseline to the final study
      visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Accept the obligation not to receive any other facial procedures or treatments at any
             time during the study that are not related to the study

          -  Women of childbearing potential must have a negative urine pregnancy test before each
             injectable treatment and practice a reliable method of contraception throughout the
             study

          -  Willing to avoid direct and prolonged sun exposure to the facial skin, which includes
             tanning beds, for the duration of the study

        Exclusion Criteria:

          -  History of any intervention to treat submental fat (SMF) (e.g. liposuction, surgery,
             or lipolytic agents)

          -  History of trauma associated with the chin or neck areas that in the judgment of the
             investigator may affect evaluation of safety or efficacy of treatment

          -  An anatomical feature (e.g. predominant subplatysmal fat, loose skin in the neck or
             chin area, prominent platysmal bands) for which reduction in SMF may, in the judgment
             of the investigator, result in an aesthetically unacceptable outcome

          -  Evidence of any cause of enlargement in the submental area (e.g. thyroid enlargement,
             cervical adenopathy, ptotic submandibular gland) other than localized SMF

          -  Any medical condition (e.g. respiratory, cardiovascular, hepatic, neurological
             disease, or thyroid dysfunction) that would interfere with assessment of safety or
             efficacy or compromise the participant's ability to undergo study procedures or give
             informed consent

          -  Body mass index (BMI) > 30

          -  Known allergy or sensitivity to the study products or their components

          -  Pregnant, lactating, or planning to become pregnant at any time during the study

          -  Received BOTOX Cosmetic® or treatment with any other botulinum toxin product for any
             condition at any time prior to entry in the study

          -  Received (or is planning to receive) anticoagulation, antiplatelet or thrombolytic
             medications (e.g. warfarin) or other substances known to increase coagulation time
             from 10 days prior to injection and up to 3 days post-injection

          -  Undergone plastic surgery of the face and/or neck, tissue grafting, or tissue
             augmentation with silicone, fat, or other permanent dermal fillers, or be planning to
             undergo any of these procedures at any time during the study

          -  Received temporary or semi-permanent facial or neck dermal filler injections (e.g.
             hyaluronic acid (HA), calcium hydroxylapatite, L-polylactic acid) at any time prior to
             entry in the study

          -  Received mesotherapy, skin resurfacing (laser, photomodulation, intense pulsed light,
             radio frequency, dermabrasion, chemical peel, or non-ablative procedures) in the face
             or neck within 6 months prior to study enrollment

          -  Began use of any new over-the-counter (OTC) or prescription, oral or topical,
             antiwrinkle products on the facial area within 90 days prior to enrollment or planning
             to begin use of such products at any time during the study

          -  Lip tattoos, facial hair or scars that would interfere with visualization of the lips
             and perioral area for the effectiveness assessments

          -  Received any investigational product within 60 days prior to study enrollment or
             planning to participate in another investigation during the course of this study

          -  An employee (or a relative of an employee) of the investigators, Allergan, or
             representative of Allergan

          -  Current use of oral corticosteroids

          -  Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin, ibuprofen)
             with the exception of a daily low dose of aspirin, from 10 days prior to injection up
             to 3 days post-injection

          -  Prescription topical retinoid therapy and/or topical hormone cream applied to the
             face, for potential participants who have not been on a consistent dose regimen for at
             least 6 months prior to enrollment and who are unable to maintain regimen for the
             study

          -  Systemic retinoid therapy within one year prior to study enrollment

          -  Medical condition that may increase the risk of exposure to botulinum toxin including
             diagnosed myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or
             any other disease that might interfere with neuromuscular function

          -  Current use of aminoglycoside antibiotics, curare-like agents, or agents that might
             interfere with neuromuscular (skeletal) function

          -  History of facial nerve palsy

          -  Anticipated need for treatment with botulinum toxin of any serotype for any reason
             during the study (other than study treatment)

          -  Tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads,
             i.e., significant convexity or projection from the infraorbital fat pads

          -  Mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose
             tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g.
             juvenile dermatomyositis), partial lipodystrophy (e.g. Barraquer-Simons syndrome),
             inherited disease, or human immunodeficiency virus-related disease

          -  Undergone oral surgery or other dental procedures (e.g. tooth extraction, orthodontia,
             or implantation) within 30 days prior to enrollment or be planning to undergo any of
             these procedures during the study

          -  Participants with neuromuscular disorders including generalized muscle weakness,
             diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise

          -  Participants with a history of allergies or hypersensitivity to HA or lidocaine