A Study of Belotero® Intense Lidocaine for Lip Augmentation

A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effectiveness of Belotero® Intense Lidocaine for Lip Augmentation

The purpose of this study is to demonstrate the safety and effectiveness of Belotero Intense Lidocaine (BIL) for lip augmentation in subjects with upper and/or lower lip deficit.

For all subjects, standardized photographs of the lips will be taken at the screening visit (prior to treatment) and at multiple intervals throughout the study to be used for comparisons and study assessments.

Subjects will receive an injection of either BIL or Restylane Silk (RS) in the upper and/or lower lips. A touch-up injection will be given 4 weeks after the initial treatment if the subject fails to show improvement in 1 or both lips or if the subject does not achieve optimal aesthetic correction. Subjects treated with BIL have the option of a retreatment with BIL 48 weeks post last injection.

Inclusion Criteria:

• Desires lip augmentation to correct volume and has very thin to medium upper and/or lower lip deficit

Exclusion Criteria:

• Any previous surgery, including plastic surgery or permanent implant or graft in the lower third part of the face
• Any previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the face
• Any treatment with porcine-based collagen fillers or with Juvéderm® Voluma XC, Restylane® Lyft Lidocaine, Calcium hydroxyapatite (CaHA) within the past 24 months and/or other dermal fillers within the past 12 months in the lips, in the lower third part of the face, and/or the nose
• Any previous treatment with dermal therapies within the past 3 months in the lower third part of the face
• Has undergone oral surgery in the past 30 days
• Lip volume deficit due to medical conditions
• Known history of allergic/anaphylactic reactions/hypersensitivity to lidocaine or any of the device components