A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a pediatric population aged 6 months to 3 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 0.5% Ivermectin Cream
|
Drug: 0.5% Ivermectin Cream
Topical 0.5% ivermectin cream applied to scalp and hair on day 1
|
Outcome Measures
Primary Outcome Measures
- Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points [Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application]
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).
- Summary of Pharmacokinetic Parameters Following Ivermectin Application. [Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application]
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).
- Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application. [Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application]
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).
- Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application. [Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application]
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).
Secondary Outcome Measures
- Number of Participants Reporting Adverse Events Following Ivermectin Treatment [Day 1 up Day 28 post-application]
Adverse events were assessed at each visit and during the follow up phone call on Day 28.
- Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin. [Day 2, Day 8 and Day 15 post-application]
Eradication of live lice was assessed by visual examination of the scalp and hair.
- Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin. [Day 2, Day 8 and Day 15 post-application]
Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin.
- Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application [Day 1, Day 2, Day 8 and Day 15 post-application]
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.
- Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application [Day 1, Day 2, Day 8 and Day 15 post-application]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject must be 6 months to 3 years of age, inclusive, when informed consent is signed.
-
Subject must be infested with head lice as demonstrated by the presence of at least 1 live louse prior to treatment.
-
Subject is in general good health.
-
Subject's parent/guardian (caregiver) must be willing and able to bring subject to all study visits as scheduled.
-
Subject's caregiver must have provided written informed consent (assent is not required due to the young age of the subjects).
-
Subject's caregiver must agree to comply with the following study restrictions:
-
will not use any other form of lice treatment (eg, commercial, community/anecdotal, or mechanical/manual) on the subject for the duration of the study, unless directed to do so by study personnel.
-
will not shampoo, wash, or rinse the subject's hair or scalp until the Day 2 treatment evaluation has been completed.
-
will not cut or chemically treat subject's hair in the period between screening and follow-up on Day 15.
-
will use only study-provided shampoo on the subject for the duration of the study.
-
will follow all study instructions.
Exclusion Criteria:
-
Subjects who have received any OTC or prescription treatment for head lice in the last 2 weeks.
-
Subjects or subjects' caregivers who are unable to comply with the study obligations and all study visits.
-
Subjects whose caregivers do not understand the requirements for participation and/or may be likely to exhibit poor compliance, in the opinion of the Investigator.
-
Subjects with eczema, atopic dermatitis, or other chronic conditions of the scalp and skin.
-
Subjects with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is > 2, blisters, or any other condition that, in the opinion of the investigative personnel or Sponsor, would interfere with the PK, safety and/or efficacy evaluations.
-
Subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.
-
Subjects with other diagnoses that, in the opinion of the Investigator, would interfere with the PK, safety, and/or efficacy assessments or would preclude study participation.
-
Subjects who have been treated with a systemic antibiotic within 2 weeks before screening.
-
Subject currently taking warfarin sodium (Coumadin®) or has taken within 2 weeks before screening.
-
Subjects who have been enrolled in any clinical study within the past 30 days; subjects may not participate in another study while participating in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Investigational Research Program | Bentonville | Arkansas | United States | 72712 |
| 2 | Universal BioPharma Research, Inc | Dinuba | California | United States | 93618 |
| 3 | Impact Clinical Trials | Los Angeles | California | United States | 90036 |
| 4 | Lice Source Solutions Inc | Plantation | Florida | United States | 33313 |
| 5 | Spence Medical Research L.L.C | Picayune | Mississippi | United States | 39466 |
Sponsors and Collaborators
- Topaz Pharmaceuticals Inc
Investigators
- Study Director: Medical Director, Sanofi Topaz
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TOP008
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled and treated from 22 September 2009 to 18 November 2009 at 3 US clinical centers. |
|---|---|
| Pre-assignment Detail | A total of 30 participants who met the inclusion and exclusion criteria were enrolled and treated. |
| Arm/Group Title | 0.5% Ivermectin |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | 0.5% Ivermectin |
|---|---|
| Arm/Group Description | Participants received a single application of 0.5% ivermectin on Day 1. |
| Overall Participants | 30 |
| Age (Count of Participants) | |
| <=18 years |
30
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Age (Months) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Months] |
25.8
(11.0)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
23
76.7%
|
| Male |
7
23.3%
|
| Region of Enrollment (Number) [Number] | |
| United States |
30
100%
|
Outcome Measures
| Title | Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population. |
| Arm/Group Title | 0.5% Ivermectin |
|---|---|
| Arm/Group Description | Participants received a single application of 0.5% ivermectin on Day 1. |
| Measure Participants | 20 |
| 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
(NA)
|
| Title | Summary of Pharmacokinetic Parameters Following Ivermectin Application. |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population. |
| Arm/Group Title | 0.5% Ivermectin |
|---|---|
| Arm/Group Description | Participants received a single application of 0.5% ivermectin on Day 1. |
| Measure Participants | 20 |
| 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)
|
| Title | Number of Participants Reporting Adverse Events Following Ivermectin Treatment |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Adverse events were assessed in the intent-to-treat population. |
| Arm/Group Title | 0.5% Ivermectin |
|---|---|
| Arm/Group Description | Participants received a single application of 0.5% ivermectin on Day 1. |
| Measure Participants | 30 |
| Diarrhea |
1
3.3%
|
| Severe Diarrhea |
0
0%
|
| Vomiting |
1
3.3%
|
| Severe Vomiting |
0
0%
|
| Gastroenteritis |
1
3.3%
|
| Severe Gastroenteritis |
0
0%
|
| Nasopharyngitis |
2
6.7%
|
| Severe Nasopharyngitis |
0
0%
|
| Upper Respiratory Tract Infection |
2
6.7%
|
| Severe Upper Respiratory Tract Infection |
0
0%
|
| Alanine Aminotransferase Increased |
2
6.7%
|
| Severe Alanine Aminotransferase Increased |
0
0%
|
| Aspartate Aminotransferase Increased |
1
3.3%
|
| Severe Aspartate Aminotransferase Increased |
0
0%
|
| Dehydration |
1
3.3%
|
| Severe Dehydration |
0
0%
|
| Dermatitis Diaper |
1
3.3%
|
| Severe Dermatitis Diaper |
0
0%
|
| Erythema |
5
16.7%
|
| Severe Erythema |
0
0%
|
| Pruritus |
1
3.3%
|
| Severe Pruritus |
0
0%
|
| Title | Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin. |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eradication of live lice was assessed in the intent-to-treat population. |
| Arm/Group Title | 0.5% Ivermectin |
|---|---|
| Arm/Group Description | Participants received a single application of 0.5% ivermectin on Day 1. |
| Measure Participants | 30 |
| Day 2 (N = 30) |
97
323.3%
|
| Day 8 (N = 29) |
90
300%
|
| Day 15 (N = 28) |
89
296.7%
|
| Title | Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin. |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eradication of live lice was assessed in the intent to treat population. |
| Arm/Group Title | 0.5% Ivermectin |
|---|---|
| Arm/Group Description | Participants received a single application of 0.5% ivermectin on Day 1. |
| Measure Participants | 30 |
| Eradication by Day 2 (N = 30) |
97
323.3%
|
| Eradication Maintained Through Day 8 and 15 (N=29) |
86
286.7%
|
| Title | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Liver function tests were performed in the intent to treat population. |
| Arm/Group Title | 0.5% Ivermectin |
|---|---|
| Arm/Group Description | Participants received a single application of 0.5% ivermectin on Day 1. |
| Measure Participants | 30 |
| 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)
|
| Title | Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Liver function tests were performed in the intent to treat population. |
| Arm/Group Title | 0.5% Ivermectin |
|---|---|
| Arm/Group Description | Participants received a single application of 0.5% ivermectin on Day 1. |
| Measure Participants | 30 |
| 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)
|
| Title | Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application. |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population. |
| Arm/Group Title | 0.5% Ivermectin |
|---|---|
| Arm/Group Description | Participants received a single application of 0.5% ivermectin on Day 1. |
| Measure Participants | 20 |
| Mean (Standard Deviation) [ng/mL] |
0.241
(0.23372)
|
| Title | Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application. |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population. |
| Arm/Group Title | 0.5% Ivermectin |
|---|---|
| Arm/Group Description | Participants received a single application of 0.5% ivermectin on Day 1. |
| Measure Participants | 20 |
| Mean (Standard Deviation) [hour] |
15.9
(10)
|
Adverse Events
| Time Frame | Adverse event data were collected from the day of application (Day 1) through Day 28 post-application | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | 0.5% Ivermectin | |
| Arm/Group Description | Participants received a single application of 0.5% ivermectin on Day 1. | |
All Cause Mortality |
||
| 0.5% Ivermectin | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| 0.5% Ivermectin | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/30 (3.3%) | |
| Infections and infestations | ||
| Gastroenteritis | 1/30 (3.3%) | 1 |
| Metabolism and nutrition disorders | ||
| Dehydration | 1/30 (3.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Dermatitis Diaper | 1/30 (3.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| 0.5% Ivermectin | ||
| Affected / at Risk (%) | # Events | |
| Total | 11/30 (36.7%) | |
| Infections and infestations | ||
| Nasopharyngitis | 2/30 (6.7%) | |
| Upper Respiratory Tract Infection | 2/30 (6.7%) | |
| Investigations | ||
| Alanine Aminotransferase Increased | 2/30 (6.7%) | |
| Skin and subcutaneous tissue disorders | ||
| Erythema | 5/30 (16.7%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Medical Director |
|---|---|
| Organization | Sanofi Topaz |
| Phone | |
| RegistryContactUs@sanofipasteur.com |
- TOP008