Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®

The aim of this study is to determine if the admixture of lidocaine can effectively be used to mediate pain relief during the injection of EVOLENCE® while achieving cosmetic correction.

Inclusion criteria

• Understanding and voluntary signature (including date) of an informed consent document
• Healthy male or female > 18 years of age
• Clinical evidence of bilateral, fully visible aging defects in the nasolabial area with grades 2.0, 2.5, or 3.0 on the Modified Fitzpatrick Wrinkle Scale (MFWS section 6.5)
• Willingness to receive EVOLENCE® injections in areas of aging defects (wrinkles)
• Willingness and ability to comply with the requirements of this protocol

Exclusion criteria

• History of multiple severe allergies (food, drug, or substances) and/or anaphylactic shock
• Subjects with a history of a bleeding disorder, or receiving chronic anti-platelet therapy or other chronic anticoagulant medication
• Subject on low-dose aspirin therapy or a non-steroidal anti-inflammatory drug, not interrupted at least 10 days prior to injection and/or resumed within 1 week after injection
• History of allergies and/or sensitivity to porcine, bovine and human collagen, lidocaine, local anesthetics products or natural rubber latex
• Autoimmune or collagen vascular disease, or connective tissue disease
• Active skin disease, inflammation or related condition such as infection, psoriasis and herpes zoster near or on the nasolabial folds area at study entry and/or within 6 months prior to study entry
• Previous tissue augmentation - permanent implants or hyaluronic acid within 6 months or EVOLENCE® within 12 months in the treatment area
• Currently being treated with immunosuppressive drugs, chemotherapy agents or systemic steroids or has been treated within the last 3 months prior to study entry
• Botulinum-toxin A within 6 weeks in treatment area
• Received any investigational products within 30 days prior to the study enrollment
• Females of Childbearing Potential
• Any clinically significant organic disease or other medical condition that in the opinion of the PI, makes the subject a poor candidate for participation in the study