A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Topaz Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT00988533
First received: October 1, 2009
Last updated: March 30, 2012
Last verified: March 2012
Results First Received: March 1, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head Lice
Intervention: Drug: 0.5% Ivermectin 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
Participants were enrolled and treated from 22 September 2009 to 18 November 2009 at 3 US clinical centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 30 participants who met the inclusion and exclusion criteria were enrolled and treated.

Reporting Groups
  Description
0.5% Ivermectin Participants received a single application of 0.5% ivermectin on Day 1.

Participant Flow:   Overall Study
    0.5% Ivermectin  
STARTED     30  
COMPLETED     27  
NOT COMPLETED     3  
Lost to Follow-up                 3  



  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 text entered.

Reporting Groups
  Description
0.5% Ivermectin Participants received a single application of 0.5% ivermectin on Day 1.

Baseline Measures
    0.5% Ivermectin  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     30  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: Months]
Mean ± Standard Deviation
  25.8  ± 11.0  
Gender  
[units: participants]
 
Female     23  
Male     7  
Region of Enrollment  
[units: Participants]
 
United States     30  



  Outcome Measures
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1.  Primary:   Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points   [ Time Frame: Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application ]

2.  Primary:   Summary of Pharmacokinetic Parameters Following Ivermectin Application.   [ Time Frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application ]

3.  Primary:   Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.   [ Time Frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application ]

4.  Primary:   Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.   [ Time Frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application ]

5.  Secondary:   Number of Participants Reporting Adverse Events Following Ivermectin Treatment   [ Time Frame: Day 1 up Day 28 post-application ]

6.  Secondary:   Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.   [ Time Frame: Day 2, Day 8 and Day 15 post-application ]

7.  Secondary:   Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.   [ Time Frame: Day 2, Day 8 and Day 15 post-application ]

8.  Secondary:   Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application   [ Time Frame: Day 1, Day 2, Day 8 and Day 15 post-application ]

9.  Secondary:   Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application   [ Time Frame: Day 1, Day 2, Day 8 and Day 15 post-application ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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 text entered.  


Results Point of Contact:  
Name/Title: Medical Director
Organization: Sanofi Topaz
e-mail: RegistryContactUs@sanofipasteur.com


No publications provided


Responsible Party: Topaz Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00988533     History of Changes
Other Study ID Numbers: TOP008
Study First Received: October 1, 2009
Results First Received: March 1, 2012
Last Updated: March 30, 2012
Health Authority: United States: Food and Drug Administration