Pain and Safety of Restylane 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 associated with injections of Restylane Lidocaine compared to Restylane using a visual analogue scale.

Official Title
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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

Conditions
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Nasolabial Fold

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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 Lidocaine<br>Restylane Lidocaine will be injected into one side nasolabial fold on Day 1 | Device: Restylane Lidocaine<br>* Intradermal injection<br>|
| Active Comparator: Restylane<br>Restylane will be injected into the opposite side nasolabial fold on Day 1 | Device: Restylane<br>* Intradermal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Difference in Pain (Restylane Lidocaine Side - Restylane Side) as Measured by a Visual Analogue Scale(VAS) | 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. | Up to 60 minutes after Injection on Day of Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | 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 | 15, 30, 45, and 60 minutes after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyaluronic Acid, Nasolabial Fold, Lidocaine