Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds

A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds

Safety & tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.

A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds

Inclusion Criteria:

• Subjects seeking augmentation therapy for correction of bilateral NLFs
• Same WSRS score at both NLFs (either both Moderate [3] or both Severe [4])
• Subjects willing to give written informed consent to participate in the study
• Women of childbearing potential willing to use an acceptable form of birth control during the study period

Exclusion Criteria:

• Active or chronic skin disease, inflammation or related conditions, near or on the NLFs
• Subjects who had undergone procedures based on active dermal response e.g., laser or chemical peeling procedures) within 6 months prior to study entry
• Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
• Permanent implant placed in the NLF area