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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pain and safety in associated with injection of Restylane Perlane Lidocaine compared to Restylane Perlane using VAS scale

Official Title
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A Randomised, Multi-center, Subject and Evaluator-blinded Study Comparing the Pain and the Safety Profile Associate With Correction of Moderate to Severe Nasolabial Folds Using Restylane Perlane Lidocaine Compared to Restylane Perlane

Conditions
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Nasolabial Fold

Intervention / Treatment
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* Device: Restylane Perlane Lidocaine
* Device: Restylane Perlane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent to participate in the study. Men or women aged 20 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 grade 3 on both NLFs or grade 4 on both NLFs. Exclusion Criteria: Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant 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 revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restylane Perlane Lidocaine<br>Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1 | Device: Restylane Perlane Lidocaine<br>* Intradermal injection<br>|
| Active Comparator: Restylane Perlane<br>Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1 | Device: Restylane Perlane<br>* Intradermal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane 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. | At the time of injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane 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 right end. The distance in mm from the left end (no pain) to the participant's VAS mark is measured with a standard ruler. | 15, 30, 45, and 60 minutes after injection |