RHA® Redensity With New Anesthetic Agent - Perioral Rhytids

Exclusion Criteria

• •1. Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
• •2. Known hypersensitivity or previous allergic reaction to any component of the study devices.
• •3. Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
• •4. Clinically significant active skin disease or infection in the perioral area within 6 months prior to study entry (TI discretion).
• •5. History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
• •6. Malignancy (excluding non-melanoma skin cancer) within the past 5 years.
• •7. History or presence of condition or feature that may confound the interpretation of the results in the perioral region, for example, tattoo, significant facial hair, acne scaring, prior surgery in the area, potential for active disease or infection flare up such as herpes simplex.
• •8. History of skin cancer in the treatment area.
• •9. Elective, clinically significant facial procedures that may confound the interpretation of the results in the perioral region (TI discretion), prior to study enrollment.
• •10. Clinically active disease or infection in the perioral area or mouth (e.g., dental abscess).
• •12\. Exposure to any other investigational drug/device within 90 days of entering the study.
• •13\. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.