Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 103 for:    IVERMECTIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00988533
Recruitment Status : Completed
First Posted : October 2, 2009
Results First Posted : April 25, 2012
Last Update Posted : April 25, 2012
Sponsor:
Information provided by (Responsible Party):
Topaz Pharmaceuticals Inc

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head Lice
Intervention Drug: 0.5% Ivermectin Cream
Enrollment 30
Recruitment Details Participants were enrolled and treated from 22 September 2009 to 18 November 2009 at 3 US clinical centers.
Pre-assignment Details A total of 30 participants who met the inclusion and exclusion criteria were enrolled and treated.
Arm/Group Title 0.5% Ivermectin
Hide Arm/Group Description Participants received a single application of 0.5% ivermectin on Day 1.
Period Title: Overall Study
Started 30
Completed 27
Not Completed 3
Reason Not Completed
Lost to Follow-up             3
Arm/Group Title 0.5% Ivermectin
Hide Arm/Group Description Participants received a single application of 0.5% ivermectin on Day 1.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
30
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 30 participants
25.8  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
23
  76.7%
Male
7
  23.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points
Hide Description Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods with a sensitivity of 0.05 ng/mL before application and on Day 1 (0.5, 1, and 6 hours), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).
Time Frame Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.
Arm/Group Title 0.5% Ivermectin
Hide Arm/Group Description:
Participants received a single application of 0.5% ivermectin on Day 1.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
0 Hour (N = 20) 0.00000  (0.00000)
0.5 Hour (N = 19) 0.02528  (0.11018)
1 Hour (N = 19) 0.08192  (0.22695)
6 Hours (N = 19) 0.20075  (0.20456)
24 Hours (N = 18) 0.16325  (0.08983)
168 Hours (N = 2) 0.05767 [1]   (NA)
[1]
Not calculated, insufficient samples
2.Primary Outcome
Title Summary of Pharmacokinetic Parameters Following Ivermectin Application.
Hide Description Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).
Time Frame Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.
Arm/Group Title 0.5% Ivermectin
Hide Arm/Group Description:
Participants received a single application of 0.5% ivermectin on Day 1.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng/h/mL
Time Averaged Plasma Concentration 0.08708  (0.11102)
Area Under Plasma Concentration Last 6.701  (11.23)
Area Under Plasma Concentration 0 to 24 3.972  (3.5142)
3.Primary Outcome
Title Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.
Hide Description Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).
Time Frame Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.
Arm/Group Title 0.5% Ivermectin
Hide Arm/Group Description:
Participants received a single application of 0.5% ivermectin on Day 1.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.241  (0.23372)
4.Primary Outcome
Title Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.
Hide Description Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).
Time Frame Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.
Arm/Group Title 0.5% Ivermectin
Hide Arm/Group Description:
Participants received a single application of 0.5% ivermectin on Day 1.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: hour
15.9  (10)
5.Secondary Outcome
Title Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse events were assessed in the intent-to-treat population.
Arm/Group Title 0.5% Ivermectin
Hide Arm/Group Description:
Participants received a single application of 0.5% ivermectin on Day 1.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: 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
6.Secondary Outcome
Title Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.
Hide Description Eradication of live lice was assessed by visual examination of the scalp and hair.
Time Frame Day 2, Day 8 and Day 15 post-application
Hide Outcome Measure Data
Hide Analysis Population Description
Eradication of live lice was assessed in the intent-to-treat population.
Arm/Group Title 0.5% Ivermectin
Hide Arm/Group Description:
Participants received a single application of 0.5% ivermectin on Day 1.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Percent of Participants
Day 2 (N = 30) 97
Day 8 (N = 29) 90
Day 15 (N = 28) 89
7.Secondary Outcome
Title Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.
Hide Description Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin.
Time Frame Day 2, Day 8 and Day 15 post-application
Hide Outcome Measure Data
Hide Analysis Population Description
Eradication of live lice was assessed in the intent to treat population.
Arm/Group Title 0.5% Ivermectin
Hide Arm/Group Description:
Participants received a single application of 0.5% ivermectin on Day 1.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Percent of Participants
Eradication by Day 2 (N = 30) 97
Eradication Maintained Through Day 8 and 15 (N=29) 86
8.Secondary Outcome
Title Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Hide Description Liver function tests (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase) were performed before Ivermectin application on Day 1 (baseline) and on Days 2, 8, and 15 after application.
Time Frame Day 1, Day 2, Day 8 and Day 15 post-application
Hide Outcome Measure Data
Hide Analysis Population Description
Liver function tests were performed in the intent to treat population.
Arm/Group Title 0.5% Ivermectin
Hide Arm/Group Description:
Participants received a single application of 0.5% ivermectin on Day 1.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: U/L
Alkaline Phosphatase - Day 1 257.9  (59.5)
Alkaline Phosphatase Day 2 258.0  (58.4)
Alkaline Phosphatase Change from Day 1 to 2 4.2  (16.5)
Alkaline Phosphatase Day 8 259.1  (51.0)
Alkaline Phosphatase Change from Day 1 to 8 -2.2  (28.4)
Alkaline Phosphatase Day 15 258.3  (52.6)
Alkaline Phosphatase Change from Day 1 to 15 -2.9  (32.3)
Alanine Aminotransferase Day 1 25.0  (20.5)
Alanine Aminotransferase Day 2 25.7  (20.9)
Alanine Aminotransferase Change from Day 1 to 2 0.2  (20.9)
Alanine Aminotransferase Day 8 25.1  (22.1)
Alanine Aminotransferase Change from Day 1 to 8 -0.2  (5.3)
Alanine Aminotransferase Day 15 24.1  (15.5)
Alanine Aminotransferase Change from Day 1 to 15 -1.1  (8.9)
Aspartate Aminotransferase Day 1 42.6  (15.4)
Aspartate Aminotransferase Day 2 41.1  (11.5)
Aspartate Aminotransferase Change from Day 1 to 2 -2.0  (15.4)
Aspartate Aminotransferase Day 8 40.3  (14.0)
Aspartate Aminotransferase Change from Day 1 to 8 -2.3  (6.8)
Aspartate Aminotransferase Day 15 39.5  (9.6)
Aspartate Aminotransferase Change from Day 1 to 15 -2.7  (10.2)
Lactate Dehydrogenase Day 1 308.0  (87.5)
Lactate Dehydrogenase Change Day 2 295.2  (35.8)
Lactate Dehydrogenase Change from Day 1 to 2 -16.8  (95.1)
Lactate Dehydrogenase Day 8 295.1  (54.0)
Lactate Dehydrogenase Change from Day 1 to 8 -10.7  (80.2)
Lactate Dehydrogenase 15 294.5  (61.3)
Lactate Dehydrogenase Change from Day 1 to 15 -9.2  (69.0)
9.Secondary Outcome
Title Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Hide Description Liver function test (total bilirubin) was performed before treatment Day 1 (baseline) and following Ivermectin application on Days 2, 8, and 15 Post-application, respectively.
Time Frame Day 1, Day 2, Day 8 and Day 15 post-application
Hide Outcome Measure Data
Hide Analysis Population Description
Liver function tests were performed in the intent to treat population.
Arm/Group Title 0.5% Ivermectin
Hide Arm/Group Description:
Participants received a single application of 0.5% ivermectin on Day 1.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: mg/dL
Total Bilirubin - Day 1 0.3  (0.3)
Total Bilirubin Day 2 0.3  (0.3)
Total Bilirubin Change from Day 1 to 2 -0.0  (0.1)
Total Bilirubin Day 8 0.3  (0.3)
Total Bilirubin Change from Day 1 to 8 -0.0  (0.1)
Total Bilirubin Day 15 0.3  (0.3)
Total Bilirubin Change from Day 1 to 15 -0.1  (0.2)
Time Frame Adverse event data were collected from the day of application (Day 1) through Day 28 post-application
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.5% Ivermectin
Hide Arm/Group Description Participants received a single application of 0.5% ivermectin on Day 1.
All-Cause Mortality
0.5% Ivermectin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
0.5% Ivermectin
Affected / at Risk (%) # Events
Total   1/30 (3.33%)    
Infections and infestations   
Gastroenteritis * 1  1/30 (3.33%)  1
Metabolism and nutrition disorders   
Dehydration * 1  1/30 (3.33%)  1
Skin and subcutaneous tissue disorders   
Dermatitis Diaper * 1  1/30 (3.33%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
0.5% Ivermectin
Affected / at Risk (%) # Events
Total   11/30 (36.67%)    
Infections and infestations   
Nasopharyngitis * 1  2/30 (6.67%) 
Upper Respiratory Tract Infection * 1  2/30 (6.67%) 
Investigations   
Alanine Aminotransferase Increased * 1  2/30 (6.67%) 
Skin and subcutaneous tissue disorders   
Erythema * 1  5/30 (16.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
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.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Topaz
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Topaz Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00988533     History of Changes
Other Study ID Numbers: TOP008
First Submitted: October 1, 2009
First Posted: October 2, 2009
Results First Submitted: March 1, 2012
Results First Posted: April 25, 2012
Last Update Posted: April 25, 2012