Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler

Exclusion Criteria

• •Has received any type of treatment or procedures including surgery in the nasolabial folds.
• •Has received neurotoxins in the lower half of the face in the past 6 months.
• •Has received hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 1 ½ years.
• •Has received polylactic acid, polymethyl methacrylate (PMMA), silicone or any other permanent filler in the lower half of the face.
• •Has nasolabial folds that are too severe to be corrected in one treatment session.
• •Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study.
• •Has a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding.
• •Is female and of child bearing potential and is pregnant or not using acceptable method of birth control.
• •Has had any history of hypersensitivity to Lidocaine or anesthetics of the amide type.
• •Has a history of anaphylaxis or multiple severe allergies.
• •Has received any investigational product within 30 days prior to study enrollment or is planning to participate in another investigation during the course of this study.