Anesthetic Effect Duration Assessment

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545765
• Other study ID #: RD.03.SPR.29103
• Status: Completed
• Phase: Phase 4
• Start date: May 2012
• Est. completion date: May 2012

Study information

• Verified date: June 2013
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
United States	Galderma Investigational center	Rochelle Park	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse Events	Incidence of adverse events was to be reported during the study period	During the study