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

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

Detailed Description
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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

Official Title
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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

Conditions
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Nasolabial Folds

Intervention / Treatment
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* Device: Restylane and Restylane-L


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restylane and Restylane with Lidocaine<br>This is a split-face design injecting both Restylane and Restylane-L injectable gels, administered once. Each subject received Restylane on one side of the face, and Restylane-L on the other. Subjects were blinded to which side of their face received Restylane or Restylane-L. The study was randomized and treatments successive. | Device: Restylane and Restylane-L<br>* This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Difference in Pain as Measured by a Visual Analogue Scale | No pain is noted at 0 mm and worst pain is noted at 100 mm. | After Injection on Day of Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wrinkle Improvement at Day 14 | This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment. | 14 days after treatment when compared to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Correction of Nasolabial Folds