Anesthetic Effect Duration Assessment

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-05-31

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.

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lidocaine 7% and tetracaine 7%

Group Type EXPERIMENTAL

Lidocaine 7% + Tetracaine 7% cream

Intervention Type DRUG

Study drug will be applied with a different application time to one side of the face and anterior thigh according to the randomization list.

Interventions

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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.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes