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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
Results First Received: June 25, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy Volunteers
Intervention: Drug: Lidocaine 7% + Tetracaine 7% cream

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
31 healthy volunteers have been enrolled in one Phase I center at USA.First subject in: May 3d 2012; Last subject ou: May 26th 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Face 2 Application Times/ Thight 2 Application Times No text entered.

Participant Flow:   Overall Study
    Face 2 Application Times/ Thight 2 Application Times  
STARTED     31  
COMPLETED     31  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No sample size determination as a standard sample size for this type of study is about 30 subjects.

Reporting Groups
  Description
Lidocaine 7% and Tetracaine 7% No text entered.

Baseline Measures
    Lidocaine 7% and Tetracaine 7%  
Number of Participants  
[units: participants]
  31  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     29  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  47.2  ± 1.27  
Gender  
[units: participants]
 
Female     20  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     31  



  Outcome Measures
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1.  Primary:   Duration of Anesthesia(Minutes)   [ Time Frame: From T0 (product removal) up to T8 hours after product removal ]

2.  Secondary:   Adverse Events   [ Time Frame: During the study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No limitation or caveat on this study


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Farzaneh Sidou Clinical Project Manager)
Organization: Galderma
phone: 00.33.4.93.95.70.70
e-mail: farzaneh.sidou@galderma.com


No publications provided


Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01545765     History of Changes
Other Study ID Numbers: RD.03.SPR29103
Study First Received: February 24, 2012
Results First Received: June 25, 2013
Last Updated: June 25, 2013
Health Authority: United States: Food and Drug Administration