Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®

Study Overview
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Brief Summary
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The study doctor will give EVOLENCE® mixed with Lidocaine to people in this study to see if it effectively reduces pain while injecting and works to correct nasolabial wrinkles. The product being used in this study is EVOLENCE®, which is currently marketed in the United States for the cosmetic correction of soft tissue contour deficiencies (including wrinkles), and been approved by the U.S. Food and Drug Administration (FDA).

Detailed Description
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The aim of this study is to determine if the admixture of lidocaine can effectively be used to mediate pain relief during the injection of EVOLENCE® while achieving cosmetic correction.

Official Title
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Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®

Conditions
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Aging, Pain

Intervention / Treatment
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* Device: Evolence
* Device: Lidocaine
* Drug: topical anesthetic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understanding and voluntary signature (including date) of an informed consent document Healthy male or female > 18 years of age Clinical evidence of bilateral, fully visible aging defects in the nasolabial area with grades 2.0, 2.5, or 3.0 on the Modified Fitzpatrick Wrinkle Scale (MFWS section 6.5) Willingness to receive EVOLENCE® injections in areas of aging defects (wrinkles) Willingness and ability to comply with the requirements of this protocol Exclusion Criteria: History of multiple severe allergies (food, drug, or substances) and/or anaphylactic shock Subjects with a history of a bleeding disorder, or receiving chronic anti-platelet therapy or other chronic anticoagulant medication Subject on low-dose aspirin therapy or a non-steroidal anti-inflammatory drug, not interrupted at least 10 days prior to injection and/or resumed within 1 week after injection History of allergies and/or sensitivity to porcine, bovine and human collagen, lidocaine, local anesthetics products or natural rubber latex Autoimmune or collagen vascular disease, or connective tissue disease Active skin disease, inflammation or related condition such as infection, psoriasis and herpes zoster near or on the nasolabial folds area at study entry and/or within 6 months prior to study entry Previous tissue augmentation - permanent implants or hyaluronic acid within 6 months or EVOLENCE® within 12 months in the treatment area Currently being treated with immunosuppressive drugs, chemotherapy agents or systemic steroids or has been treated within the last 3 months prior to study entry Botulinum-toxin A within 6 weeks in treatment area Received any investigational products within 30 days prior to the study enrollment Females of Childbearing Potential Any clinically significant organic disease or other medical condition that in the opinion of the PI, makes the subject a poor candidate for participation in the study

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain assessment for Evolence/topical anesthetic<br>Assess injection pain severity for a one time 1.0 mL injection of Evolence with 0.2 ml of topical anesthetic, applied 30 minutes prior to injection, to the left nasolabial fold of each participant . | Device: Evolence<br>* Injectable collagen<br>* Other names: Dermicol-P35 27G;Drug: topical anesthetic<br> <br> |
| Experimental: Pain assessment for Evolence/Lidocaine<br>Assess injection pain severity for a one time 1.0 mL injection of Evolence mixed with 0.18 mL of 2% lidocaine (0.3% final lidocaine-HCl) in the right nasolabial fold of each participant. | Device: Evolence<br>* Injectable collagen<br>* Other names: Dermicol-P35 27G;Device: Lidocaine<br>* admix anesthetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Immediate Post-injection Pain Severity by Subject | Subjects assessment of immediate post-injection pain severity using a visual analogue scale (VAS) 100 mm in length, ranging from no pain (0) to unbearable pain (100). | immediate post-injection | 
| Assessment of Immediate Post-injection Pain Severity by Investigator | Investigators assessment of immediate post-injection pain severity using Thermometer Pain Scale (TPS) with a range of 0-10 where 0=no pain and 10=worst possible pain | immediate post injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wrinkles, dermal filler, collagen, soft tissue augmentation, lidocaine, aesthetic