Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE® (AD-1016)
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®|
- Severity of injection pain measured by Thermometer Pain Scale. [ Time Frame: Immediate ] [ Designated as safety issue: No ]
- Pain, swelling, bruising, redness [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Study Completion Date:||February 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Experimental: Pain assessment
Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
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.
|United States, Florida|
|Susan Weinkle, Private Practice|
|Bradenton, Florida, United States, 34209|
|Principal Investigator:||Susan Weinkle, MD||Private Practice|