Study to Evaluate Safety and Efficacy of Revanesse® Ultra + vs Revanesse® Ultra 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, or had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months (180 days) prior to study entry.
• •4. Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry.
• •5. Has ever received semi-permanent fillers anywhere in the face or neck, or is planning to be implanted with these products during the study.
• •6. Has a permanent implant placed in the NLF area.
• •7. Evidence of scar-related disease or delayed healing activity within the past 1 year.
• •8. Scars at the intended treatment sites.
• •9. History of keloid formation or hypertrophic scars.
• •10. Any infection or unhealed wound on the face.
• •11. Allergic history including anaphylaxis, multiple severe allergies, atopy, or allergies to natural rubber latex, lidocaine or any amide-based anesthetic, hyaluronic acid products, or Streptococcal proteins or have plans to undergo desensitization therapy during the term of the study.
• •12. Aspirin or nonsteroidal anti-inflammatory drugs within 1 week (7 days) prior to treatment.
• •13. Concomitant anticoagulant therapy, antiplatelet therapy, or history of bleeding disorders, coagulation defects or connective tissue disorders.
• •14. Over-the-counter (OTC) wrinkle products or prescription wrinkle treatments within 4 weeks (28 days) prior to treatment and throughout the study.
• •15. Immunocompromised or immunosuppressed.
• •16. 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.
• •17. Received any investigational product within 30 days of signing the Informed Consent Form.
• •18. Facial tattoo that may interfere with diagnosis.
• •19. 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.
• •20. Acne and/or other inflammatory diseases of the skin.
• •21. Acute or chronic skin disease, inflammation or related conditions, cancerous or precancerous lesions on or near the injection sites.-