Anesthetic Effect Duration Assessment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Lidocaine 7% + Tetracaine 7% cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine 7% and tetracaine 7%<br> | Drug: Lidocaine 7% + Tetracaine 7% cream<br>* Study drug will be applied with a different application time to one side of the face and anterior thigh according to the randomization list.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Anesthesia(Minutes) | Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes). | From T0 (product removal) up to T8 hours after product removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidence of adverse events was to be reported during the study period | During the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers