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

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Restylane Lidocaine	Restylane Lidocaine	Restylane Lidocaine will be injected into one side nasolabial fold on Day 1
Restylane	Restylane	Restylane will be injected into the opposite side nasolabial fold on Day 1

Primary Outcome Measures

Name	Time	Method
Treatment Difference in Pain (Restylane Lidocaine Side - Restylane Side) as Measured by a Visual Analogue Scale(VAS)	Up to 60 minutes after Injection on Day of Treatment	Subjects that reported at least 10 mm less VAS pain associated with injections of Restylane-Lido compared to Restylane at the time of injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the participant's VAS mark is measured with a standard ruler.

Secondary Outcome Measures

Name	Time	Method
Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)	15, 30, 45, and 60 minutes after injection	Subjects that reported at least 10 mm less VAS pain associated with injections of Restylane-Lido compared to Restylane at 15, 30, 45 and 60 minutes after injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the rig