Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE® (AD-1016)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00929071|
Recruitment Status : Completed
First Posted : June 26, 2009
Results First Posted : July 11, 2014
Last Update Posted : August 7, 2014
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).
|Condition or disease||Intervention/treatment||Phase|
|Aging Pain||Device: Evolence Device: Lidocaine Drug: topical anesthetic||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||February 2009|
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 .
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.
- Assessment of Immediate Post-injection Pain Severity by Subject [ Time Frame: immediate post-injection ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929071
|United States, Florida|
|Susan Weinkle, Private Practice|
|Bradenton, Florida, United States, 34209|
|Principal Investigator:||Susan Weinkle, MD||Private Practice|