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Anesthetic Effect Duration Assessment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01545765
First received: February 24, 2012
Last updated: June 25, 2013
Last verified: June 2013

February 24, 2012
June 25, 2013
May 2012
May 2012   (final data collection date for primary outcome measure)
Duration of Anesthesia(Minutes) [ Time Frame: From T0 (product removal) up to T8 hours after product removal ] [ Designated as safety issue: No ]
Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes).
Duration of anesthesia [ Time Frame: From product removal up to T8 hours after product removal ] [ Designated as safety issue: No ]
Duration of anesthesia will be the difference between the onset and end of anesthesia.
Complete list of historical versions of study NCT01545765 on ClinicalTrials.gov Archive Site
Adverse Events [ Time Frame: During the study ] [ Designated as safety issue: Yes ]
Incidence of adverse events was to be reported during the study period
Adverse Events [ Time Frame: At Baseline, Day 2 and Day 4 (at each study visit) ] [ Designated as safety issue: Yes ]
Incidence of adverse events will be reported
Not Provided
Not Provided
 
Anesthetic Effect Duration Assessment
Anesthetic Effect Duration Produced by Lidocaine 7% + Tetracaine 7% Cream on 2 Different Body Areas

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers
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.
Experimental: lidocaine 7% and tetracaine 7%
Intervention: Drug: Lidocaine 7% + Tetracaine 7% cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01545765
RD.03.SPR29103
No
Galderma
Galderma
Not Provided
Principal Investigator: Regina YAVEL, MD- Dermatologist Galderma investigational center
Galderma
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP