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Completed

NCT Number: NCT01545765

Anesthetic Effect Duration Assessment

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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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Galderma Investigational center

Rochelle Park, New Jersey, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine 7% + Tetracaine 7% cream

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Adverse Events

    Time frame: During the study

    Incidence of adverse events was to be reported during the study period

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 7, 2012
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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