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

Evaluation of Pain With the Use of Lidocaine-Mixed Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds

To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler mixed with lidocaine.

To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler mixed with lidocaine in one nasolabial fold compared to Radiesse® Injectable Dermal Filler without lidocaine in the contralateral nasolabial fold.

Inclusion Criteria:

• Is at least 18 years of age.
• Is a candidate for nasolabial fold treatment using Radiesse.
• Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month.
• Understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.
• Has approximately symmetrical nasolabial folds.

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.