A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation (LICE OUT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Topaz Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT01066585
First received: February 8, 2010
Last updated: April 4, 2012
Last verified: April 2012
Results First Received: March 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Head Lice
Interventions: Drug: Ivermectin Cream
Drug: vehicle control

  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 8 March 2010 to 9 June 2010 in 8 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 410 participants who met the inclusion and exclusion criteria were enrolled and treated.

Reporting Groups
  Description
0.5% Ivermectin Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
Vehicle Control Participants underwent a single treatment with vehicle control cream at home on Day 1.

Participant Flow:   Overall Study
    0.5% Ivermectin     Vehicle Control  
STARTED     211     199  
COMPLETED     210     196  
NOT COMPLETED     1     3  
Protocol Violation                 1                 0  
Withdrawal by Subject                 0                 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 underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
Vehicle Control Participants underwent a single treatment with vehicle control cream at home on Day 1.
Total Total of all reporting groups

Baseline Measures
    0.5% Ivermectin     Vehicle Control     Total  
Number of Participants  
[units: participants]
  211     199     410  
Age  
[units: participants]
     
<=18 years     164     149     313  
Between 18 and 65 years     47     50     97  
>=65 years     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation
  13.92  ± 12.00     15.05  ± 13.52     14.47  ± 12.76  
Gender  
[units: participants]
     
Female     172     164     336  
Male     39     35     74  
Region of Enrollment  
[units: Participants]
     
United States     211     199     410  



  Outcome Measures
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1.  Primary:   Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)   [ Time Frame: Day 2 up to Day 15 post-application ]

2.  Secondary:   Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)   [ Time Frame: Day 2 up to Day 15 post-application ]

3.  Secondary:   Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)   [ Time Frame: Day 1 up to Day 15 post-application. ]

4.  Secondary:   Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)   [ Time Frame: Day 1 up to 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 by Topaz Pharmaceuticals Inc

Publications automatically indexed to this study:

Responsible Party: Topaz Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT01066585     History of Changes
Other Study ID Numbers: TOP011
Study First Received: February 8, 2010
Results First Received: March 7, 2012
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration