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Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Topaz Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT00857948
First received: March 6, 2009
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
Results First Received: March 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pediculus Humanus Capitis (Head Lice)
Interventions: Drug: ivermectin treatment conditioner
Drug: Placebo, 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 on 14 March 2009 in 1 US clinical center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 78 participants who met the inclusion and exclusion criteria were enrolled and treated.

Reporting Groups
  Description
0.15% Ivermectin Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
0.25% Ivermectin Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
0.50% Ivermectin Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
Placebo Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.

Participant Flow:   Overall Study
    0.15% Ivermectin     0.25% Ivermectin     0.50% Ivermectin     Placebo  
STARTED     18     18     19     23  
COMPLETED     15     18     18     23  
NOT COMPLETED     3     0     1     0  
Withdrawal by Subject                 2                 0                 0                 0  
Protocol Violation                 1                 0                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
0.15% Ivermectin Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
0.25% Ivermectin Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
0.50% Ivermectin Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
Placebo Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
Total Total of all reporting groups

Baseline Measures
    0.15% Ivermectin     0.25% Ivermectin     0.50% Ivermectin     Placebo     Total  
Number of Participants  
[units: participants]
 		  18     18     19     23     78  
Age  
[units: participants]
 		         
<=18 years     16     14     13     21     64  
Between 18 and 65 years     2     4     6     2     14  
>=65 years     0     0     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation 		         
Age Continuous     12.28  ± 13.00     14.11  ± 8.71     14.21  ± 12.87     11.13  ± 8.73     12.83  ± 10.79  
Gender  
[units: participants]
 		         
Female     15     15     18     22     70  
Male     3     3     1     1     8  
Region of Enrollment  
[units: Participants]
 		         
United States     18     18     19     23     78  



  Outcome Measures
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1.  Primary:   Percentage of 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 1 through Day 15 post-application ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)   [ Time Frame: Day 1 through Day 8 post-application ]
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Measure Type Secondary
Measure Title Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Measure Description Live lice eradication was assessed on Days 1, 2, and 8 by visual checks of hair and scalp. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.
Time Frame Day 1 through Day 8 post-application  
Safety Issue No  

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.
Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.

Reporting Groups
  Description
0.15% Ivermectin Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
0.25% Ivermectin Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
0.50% Ivermectin Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
Placebo Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.

Measured Values
    0.15% Ivermectin     0.25% Ivermectin     0.50% Ivermectin     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  18     18     19     23  
Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)  
[units: Percent of participants]
 		       
Day 1: 2 hours post-application     33     44     32     22  
Day 1: 6 hours post-application     50     67     58     30  
Day 2     83     94     95     17  
Day 8     67     72     84     9  

No statistical analysis provided for Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)



3.  Secondary:   Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)   [ Time Frame: Day 1 through Day 15 post-application ]
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4.  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 28 post-application ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  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: NCT00857948     History of Changes
Other Study ID Numbers: TOP003
Study First Received: March 6, 2009
Results First Received: March 1, 2012
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration