Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose

Study Overview
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Brief Summary
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Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.

Detailed Description
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This is a split-face design. All 60 subjects receive Perlane on one side of their face, and Perlane-L on the other. Subjects and the investigator is blinded to which side of face receives which product. These are one time injections.

Official Title
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A Randomized, Double-Blind Study Comparing Safety and Tolerability of Perlane® 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: Perlane and Perlane-L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Same Wrinkle Severity Rating Scale score at both Nasolabial Folds (either both Moderate [3] or both Severe [4]) Exclusion Criteria: Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds 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 Nasolabial Fold 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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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: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm |  | After Injection on Day of Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Showing 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