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

History of Changes

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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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 ]

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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 ]

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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 ]

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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 ]

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5. Secondary:

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

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Measure Type	Secondary
Measure Title	Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Measure Description	Adverse events were assessed at each visit and during the follow up phone call on Day 28.
Time Frame	Day 1 up Day 28 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.
Adverse events were assessed in the intent-to-treat population.

Reporting Groups

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

Measured Values

	0.5% Ivermectin
Number of Participants Analyzed [units: participants]	30
Number of Participants Reporting Adverse Events Following Ivermectin Treatment [units: Participants]
Diarrhea	1
Severe Diarrhea	0
Vomiting	1
Severe Vomiting	0
Gastroenteritis	1
Severe Gastroenteritis	0
Nasopharyngitis	2
Severe Nasopharyngitis	0
Upper Respiratory Tract Infection	2
Severe Upper Respiratory Tract Infection	0
Alanine Aminotransferase Increased	2
Severe Alanine Aminotransferase Increased	0
Aspartate Aminotransferase Increased	1
Severe Aspartate Aminotransferase Increased	0
Dehydration	1
Severe Dehydration	0
Dermatitis Diaper	1
Severe Dermatitis Diaper	0
Erythema	5
Severe Erythema	0
Pruritus	1
Severe Pruritus	0

No statistical analysis provided for Number of Participants Reporting Adverse Events Following Ivermectin Treatment

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 ]

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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 ]

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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 ]

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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 ]

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications

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

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