A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula

A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula

The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face.

Inclusion Criteria:

Male or female aged 35 to 65 (inclusive) years of age with overall mid-face severity of Moderate, Significant, or Severe for both cheeks on the Mid-Face Volume Deficit Scale (MFVDS);

Exclusion criteria:

• Has any facial procedures or trauma that may interfere with the study procedures and results;
• Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo allergen desensitization therapy during the term of the study;
• Has active autoimmune disease;
• Has current cutaneous or mucosal inflammatory or infectious processes.