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®|
- Assessment of Immediate Post-injection Pain Severity by Subject [ Time Frame: immediate post-injection ] [ Designated as safety issue: No ]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).
- Assessment of Immediate Post-injection Pain Severity by Investigator [ Time Frame: immediate post injection ] [ Designated as safety issue: No ]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
|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 for Evolence/topical anesthetic
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 .
Other Names:Drug: topical anesthetic
Experimental: Pain assessment for Evolence/Lidocaine
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.
Other Names:Device: Lidocaine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929071
|United States, Florida|
|Susan Weinkle, Private Practice|
|Bradenton, Florida, United States, 34209|
|Principal Investigator:||Susan Weinkle, MD||Private Practice|