Multicenter Double-Blind Randomized Split-Face Study to Evaluate Revanesse® Ultra vs Restylane® for Correction of NLF

Exclusion Criteria

• •Subjects who meet any of the following criteria will be excluded from the study:
• •1. Wrinkle Severity Rating Scale Score of ≤ 2 on the right or left nasolabial fold.
• •2. Women who are pregnant or lactating.
• •3. Received prior dermabrasion, facelift, or Botox below the orbital rim within 6 months (180 days) prior to entry into the study.
• •4. Previous tissue augmentation (bulking agents) for facial wrinkles and scars within 6 months (180 days) at the proposed injection sites.
• •5. Previous tissue augmentation with permanent implants.
• •6. Evidence of scar-related disease or delayed healing activity within the past 1 year.
• •7. Scars at the intended treatment sites.
• •8. History of keloid formation or hypertrophic scars.
• •9. Any infection or wound on the face.
• •10. Allergic history including anaphylaxis or multiple severe allergies to natural rubber latex or lidocaine.
• •11. Aspirin or nonsteroidal anti-inflammatory drugs within 1 week (7 days) prior to treatment.
• •12. Concomitant anticoagulant therapy, antiplatelet therapy, or history of bleeding disorders or connective tissue disorders.
• •13. Over-the-counter (OTC) wrinkle products or prescription wrinkle treatments within 4 weeks (28 days) prior to treatment and throughout the study.
• •14. Immunocompromised or immunosuppressed.
• •15. Clinically significant organic disease including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, preclude participation in the trial.
• •16. Received any investigational product within 30 days of signing the Informed Consent Form.
• •17. Facial tattoo that may interfere with diagnosis.
• •18. Systemic (oral/injectable) corticosteroids or immunosuppressive medications within 30 days prior to treatment and topical steroids on the face within 14 days prior to treatment start and throughout the study.
• •\-