Trial Outcomes & Findings for A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age (NCT NCT00988533)
NCT ID: NCT00988533
Last Updated: 2012-04-25
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application
Results posted on
2012-04-25
Participant Flow
Participants were enrolled and treated from 22 September 2009 to 18 November 2009 at 3 US clinical centers.
A total of 30 participants who met the inclusion and exclusion criteria were enrolled and treated.
Participant milestones
| Measure |
0.5% Ivermectin
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
0.5% Ivermectin
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age
Baseline characteristics by cohort
| Measure |
0.5% Ivermectin
n=30 Participants
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
25.8 Months
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before; 0.5, 1, 6, 24 hours and Up to 14 days post-applicationPopulation: Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.
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).
Outcome measures
| Measure |
0.5% Ivermectin
n=20 Participants
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points
0 Hour (N = 20)
|
0.00000 ng/mL
Standard Deviation 0.00000 • Interval 0.0 to
|
|
Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points
0.5 Hour (N = 19)
|
0.02528 ng/mL
Standard Deviation 0.11018 • Interval 0.11018 to
|
|
Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points
1 Hour (N = 19)
|
0.08192 ng/mL
Standard Deviation 0.22695 • Interval 0.22695 to
|
|
Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points
6 Hours (N = 19)
|
0.20075 ng/mL
Standard Deviation 0.20456 • Interval 0.20456 to
|
|
Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points
24 Hours (N = 18)
|
0.16325 ng/mL
Standard Deviation 0.08983 • Interval 0.08983 to
|
|
Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points
168 Hours (N = 2)
|
0.05767 ng/mL
Standard Deviation NA
Not calculated, insufficient samples
|
PRIMARY outcome
Timeframe: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-applicationPopulation: Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.
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).
Outcome measures
| Measure |
0.5% Ivermectin
n=20 Participants
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Summary of Pharmacokinetic Parameters Following Ivermectin Application.
Time Averaged Plasma Concentration
|
0.08708 ng/h/mL
Standard Deviation 0.11102 • Interval 0.11102 to
|
|
Summary of Pharmacokinetic Parameters Following Ivermectin Application.
Area Under Plasma Concentration Last
|
6.701 ng/h/mL
Standard Deviation 11.23 • Interval 11.23 to
|
|
Summary of Pharmacokinetic Parameters Following Ivermectin Application.
Area Under Plasma Concentration 0 to 24
|
3.972 ng/h/mL
Standard Deviation 3.5142 • Interval 3.5142 to
|
PRIMARY outcome
Timeframe: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-applicationPopulation: Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.
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).
Outcome measures
| Measure |
0.5% Ivermectin
n=20 Participants
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.
|
0.241 ng/mL
Standard Deviation 0.23372
|
PRIMARY outcome
Timeframe: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-applicationPopulation: Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.
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).
Outcome measures
| Measure |
0.5% Ivermectin
n=20 Participants
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.
|
15.9 hour
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Day 1 up Day 28 post-applicationPopulation: Adverse events were assessed in the intent-to-treat population.
Adverse events were assessed at each visit and during the follow up phone call on Day 28.
Outcome measures
| Measure |
0.5% Ivermectin
n=30 Participants
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Diarrhea
|
1 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Severe Diarrhea
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Vomiting
|
1 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Severe Vomiting
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Gastroenteritis
|
1 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Severe Gastroenteritis
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Nasopharyngitis
|
2 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Severe Nasopharyngitis
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Upper Respiratory Tract Infection
|
2 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Severe Upper Respiratory Tract Infection
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Alanine Aminotransferase Increased
|
2 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Severe Alanine Aminotransferase Increased
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Aspartate Aminotransferase Increased
|
1 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Dehydration
|
1 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Severe Dehydration
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Dermatitis Diaper
|
1 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Severe Dermatitis Diaper
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Erythema
|
5 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Severe Erythema
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Pruritus
|
1 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Severe Pruritus
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Severe Aspartate Aminotransferase Increased
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2, Day 8 and Day 15 post-applicationPopulation: Eradication of live lice was assessed in the intent-to-treat population.
Eradication of live lice was assessed by visual examination of the scalp and hair.
Outcome measures
| Measure |
0.5% Ivermectin
n=30 Participants
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.
Day 2 (N = 30)
|
97 Percent of Participants
|
|
Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.
Day 8 (N = 29)
|
90 Percent of Participants
|
|
Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.
Day 15 (N = 28)
|
89 Percent of Participants
|
SECONDARY outcome
Timeframe: Day 2, Day 8 and Day 15 post-applicationPopulation: Eradication of live lice was assessed in the intent to treat population.
Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin.
Outcome measures
| Measure |
0.5% Ivermectin
n=30 Participants
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.
Eradication by Day 2 (N = 30)
|
97 Percent of Participants
|
|
Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.
Eradication Maintained Through Day 8 and 15 (N=29)
|
86 Percent of Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 8 and Day 15 post-applicationPopulation: Liver function tests were performed in the intent to treat population.
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.
Outcome measures
| Measure |
0.5% Ivermectin
n=30 Participants
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alkaline Phosphatase - Day 1
|
257.9 U/L
Standard Deviation 59.5
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alkaline Phosphatase Day 2
|
258.0 U/L
Standard Deviation 58.4
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alkaline Phosphatase Change from Day 1 to 2
|
4.2 U/L
Standard Deviation 16.5
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alkaline Phosphatase Day 8
|
259.1 U/L
Standard Deviation 51.0
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alkaline Phosphatase Change from Day 1 to 8
|
-2.2 U/L
Standard Deviation 28.4
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alkaline Phosphatase Day 15
|
258.3 U/L
Standard Deviation 52.6
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alkaline Phosphatase Change from Day 1 to 15
|
-2.9 U/L
Standard Deviation 32.3
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alanine Aminotransferase Day 1
|
25.0 U/L
Standard Deviation 20.5
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alanine Aminotransferase Day 2
|
25.7 U/L
Standard Deviation 20.9
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alanine Aminotransferase Change from Day 1 to 2
|
0.2 U/L
Standard Deviation 20.9
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alanine Aminotransferase Day 8
|
25.1 U/L
Standard Deviation 22.1
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alanine Aminotransferase Change from Day 1 to 8
|
-0.2 U/L
Standard Deviation 5.3
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alanine Aminotransferase Day 15
|
24.1 U/L
Standard Deviation 15.5
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Alanine Aminotransferase Change from Day 1 to 15
|
-1.1 U/L
Standard Deviation 8.9
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Aspartate Aminotransferase Day 1
|
42.6 U/L
Standard Deviation 15.4
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Aspartate Aminotransferase Day 2
|
41.1 U/L
Standard Deviation 11.5
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Aspartate Aminotransferase Change from Day 1 to 2
|
-2.0 U/L
Standard Deviation 15.4
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Aspartate Aminotransferase Day 8
|
40.3 U/L
Standard Deviation 14.0
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Aspartate Aminotransferase Change from Day 1 to 8
|
-2.3 U/L
Standard Deviation 6.8
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Aspartate Aminotransferase Day 15
|
39.5 U/L
Standard Deviation 9.6
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Aspartate Aminotransferase Change from Day 1 to 15
|
-2.7 U/L
Standard Deviation 10.2
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Lactate Dehydrogenase Day 1
|
308.0 U/L
Standard Deviation 87.5
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Lactate Dehydrogenase Change Day 2
|
295.2 U/L
Standard Deviation 35.8
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Lactate Dehydrogenase Change from Day 1 to 2
|
-16.8 U/L
Standard Deviation 95.1
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Lactate Dehydrogenase Day 8
|
295.1 U/L
Standard Deviation 54.0
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Lactate Dehydrogenase Change from Day 1 to 8
|
-10.7 U/L
Standard Deviation 80.2
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Lactate Dehydrogenase 15
|
294.5 U/L
Standard Deviation 61.3
|
|
Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Lactate Dehydrogenase Change from Day 1 to 15
|
-9.2 U/L
Standard Deviation 69.0
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 8 and Day 15 post-applicationPopulation: Liver function tests were performed in the intent to treat population.
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.
Outcome measures
| Measure |
0.5% Ivermectin
n=30 Participants
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Total Bilirubin - Day 1
|
0.3 mg/dL
Standard Deviation 0.3
|
|
Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Total Bilirubin Day 2
|
0.3 mg/dL
Standard Deviation 0.3
|
|
Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Total Bilirubin Change from Day 1 to 2
|
-0.0 mg/dL
Standard Deviation 0.1
|
|
Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Total Bilirubin Day 8
|
0.3 mg/dL
Standard Deviation 0.3
|
|
Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Total Bilirubin Change from Day 1 to 8
|
-0.0 mg/dL
Standard Deviation 0.1
|
|
Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Total Bilirubin Day 15
|
0.3 mg/dL
Standard Deviation 0.3
|
|
Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application
Total Bilirubin Change from Day 1 to 15
|
-0.1 mg/dL
Standard Deviation 0.2
|
Adverse Events
0.5% Ivermectin
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.5% Ivermectin
n=30 participants at risk
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Infections and infestations
Gastroenteritis
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected from the day of application (Day 1) through Day 28 post-application
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected from the day of application (Day 1) through Day 28 post-application
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected from the day of application (Day 1) through Day 28 post-application
|
Other adverse events
| Measure |
0.5% Ivermectin
n=30 participants at risk
Participants received a single application of 0.5% ivermectin on Day 1.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.7%
2/30 • Adverse event data were collected from the day of application (Day 1) through Day 28 post-application
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.7%
2/30 • Adverse event data were collected from the day of application (Day 1) through Day 28 post-application
|
|
Investigations
Alanine Aminotransferase Increased
|
6.7%
2/30 • Adverse event data were collected from the day of application (Day 1) through Day 28 post-application
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
5/30 • Adverse event data were collected from the day of application (Day 1) through Day 28 post-application
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER