Anesthetic Effect Duration Assessment

Phase 4

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Lidocaine 7% + Tetracaine 7% cream

• Registration Number: NCT01545765
• Lead Sponsor: Galderma R&D

Brief 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.

Study Timeline

• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-07
• Study Start: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-06
• Results First Submitted: 2013-06-25
• Results First Submitted QC: 2013-06-25
• Results First Posted: 2013-09-04
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy male of female subjects aged 18 or older with a normal not excessive hairy skin,

Exclusion Criteria

• Female subjects who are pregnant or breast-feeding; or plan to become pregnant,
• Subjects who have a known allergy to one of the components of the test drug lidocaine, tetracaine or other local anesthetics,
• Subjects who are at risk in terms of precautions, warnings, and contra-indication with the study product.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lidocaine 7% and tetracaine 7%	Lidocaine 7% + Tetracaine 7% cream	-

Primary Outcome Measures

Name	Time	Method
Duration of Anesthesia(Minutes)	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).

Secondary Outcome Measures

Name	Time	Method
Adverse Events	During the study	Incidence of adverse events was to be reported during the study period

Trial Locations

Locations (1)

Galderma Investigational center; 🇺🇸 Rochelle Park, New Jersey, United States