Pain and Safety of Restylane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds

A Randomised, Multi-center, Subject and Evaluator-blinded Study Comparing Pain and Safety Profile Associated With Correction of Moderate to Severe Nasolabial Folds Using Restylane With and Without Addition of 0.3% Lidocaine Hydrochloride

The purpose of this study is to evaluate the pain and safety associated with injections of Restylane Lidocaine compared to Restylane using a visual analogue scale.

Inclusion Criteria:

• Signed informed consent
• Men or women aged 18 years or older of Chinese origin
• Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study
• Intent to undergo correction of both nasolabial folds(NLF) with a wrinkle severity in Wrinkle Severity Rating Scale(WSRS) of either 3 on both sides or 4 on both sides

Exclusion Criteria:

• Previous use of any permanent (non-biodegradable) or semi-permanent facial tissue augmentation therapy or autologous fat below the level of the lower orbital rim
• Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment
• Previous tissue revitalisation treatment with laser or light, mesotherapy radiofrequency, chemical peeling or dermabrasion in the midface within 6 months before treatment
• Scars or deformities, active skin disease, inflammation or related conditions near or in the area to be treated
• Other condition preventing the subject from entering the study in the Investigator's opinion