Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
Condition: Contour
Intervention: BELKYRA®; Juvéderm® VOLUMA™ with Lidocaine
Intervention description: BELKYRA® was injected into preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart).; Juvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Lower Face Contouring

Summary:

      This study has been designed to evaluate the safety and effectiveness of sequential treatment
      with BELKYRA® (for the treatment of convexity and fullness associated with submental fat) and
      VOLUMA™ (to restore volume along the mandibular border) to enhance the overall contour of the
      jawline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Grade 2 or above on Allergan Loss of Jawline Definition Scale (ALJDS)

          -  Grade 2 or 3 on reported Clinician-Rated Submental Fat Rating Scale (CR-SMFRS)

          -  Stable body weight for at least 26 weeks

          -  Accept the obligation to forego any treatment or behavior (e.g., unshaven facial hair;
             significant changes to dietary or exercise habits) during the participants
             participation in the study that may affect the assessments of the submental area

        Exclusion Criteria:

          -  Grade 4 on Submental Skin Laxity Grade (SMSLG)

          -  Grade 4 on Allergan Jowl Fat Rating Scale (AJFRS)

          -  Body mass index (BMI) >35 kg/m^2

          -  History of, or current symptoms of dysphagia

          -  History of temporary, semi-permanent or permanent facial or neck dermal filler
             injections below the medial canthi at any time prior to treatment, or within 52 weeks
             before Screening for treatment above the medial canthi

          -  History of facial and/or neck plastic surgery, tissue grafting or permanent facial
             implants anywhere in the face or neck

          -  History of any intervention (e.g., liposuction, surgery, or lipolytic agents) to treat
             submental fat (SMF)

          -  Evidence of any cause of enlargement in the submental area other than localized SMF

          -  History of mesotherapy or ablative procedures to the face and/or neck 52 weeks before
             Screening

          -  History of skin resurfacing in the neck or submental area within 26 weeks before
             Screening

          -  Treatment with botulinum toxin injections in the neck or submental area within 26
             weeks before Screening

          -  Participants on prescription topical retinoid therapy and/or topical hormone cream
             applied to the face, who have not been on a consistent dose regimen for at least 26
             weeks before Screening and who are unable to maintain regimen for the study

          -  Systemic retinoid therapy within 52 weeks before Screening

          -  Current use of oral corticosteroids

          -  Is on a regimen of anticoagulation therapy (eg, warfarin, clopidogrel)

          -  Has current injection site inflammatory or infectious processes, abscess, an unhealed
             wound, or a known cancerous or precancerous lesion in chin, masseter, or submental
             region

          -  Planned oral surgery or other dental procedures (e.g., tooth extraction, orthodontia,
             or implantation) within 2 weeks prior to and after VOLUMA™ treatment