NCT01545765

Anesthetic Effect Duration Assessment

Anesthetic Effect Duration Produced by Lidocaine 7% + Tetracaine 7% Cream on 2 Different Body Areas

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the duration of anesthetic effect produced , Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the face and thigh.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-03-07
• Last updated: 2021-09-02
• Results posted: 2013-09-04

Locations

1 site across 1 country: United States