Anesthetic Effect Duration Assessment
|ClinicalTrials.gov Identifier: NCT01545765|
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : September 4, 2013
Last Update Posted : September 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Lidocaine 7% + Tetracaine 7% cream||Phase 4|
Subjects will have 4 target zones defined; 2 on the face and 2 on the anterior thighs. Upon inclusion into the study, subjects will have the study drug applied with a different application time to one side of the face and anterior thigh according to the randomization. After the completion of the application process, study drug on both sides of the face and on both anterior thighs will be removed by peeling.
After drug removal, the duration of anesthetic effect of the study drug will be tested using a pinprick test. Five (5) pinpricks using a 21-gauge needle will be performed at the 4 target zones (each side of the face and both anterior thighs). The pinprick test will be repeated up to 8 hours after drug removal. There will be a total of 20 post drug removal pinprick test completed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anesthetic Effect Duration Produced by Lidocaine 7% + Tetracaine 7% Cream on 2 Different Body Areas|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
|Experimental: lidocaine 7% and tetracaine 7%||
Drug: Lidocaine 7% + Tetracaine 7% cream
Study drug will be applied with a different application time to one side of the face and anterior thigh according to the randomization list.
- Duration of Anesthesia(Minutes) [ Time Frame: From T0 (product removal) up to T8 hours after product removal ]Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes).
- Adverse Events [ Time Frame: During the study ]Incidence of adverse events was to be reported during the study period
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): NCT01545765
|United States, New Jersey|
|Galderma Investigational center|
|Rochelle Park, New Jersey, United States|
|Principal Investigator:||Regina YAVEL, MD- Dermatologist||Galderma investigational center|