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

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label Study to Assess the Bioavailability, Safety, Local Tolerance, and Efficacy of 0.5% Ivermectin Cream in Subjects 6 Months to 3 Years of Age With Pediculus Humanus Capitis (Head Lice) Infestation

Conditions
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Head Lice

Intervention / Treatment
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* Drug: 0.5% Ivermectin Cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5% Ivermectin Cream<br> | Drug: 0.5% Ivermectin Cream<br>* Topical 0.5% ivermectin cream applied to scalp and hair on day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points | 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). | Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application | 
| Summary of Pharmacokinetic Parameters Following Ivermectin 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). | Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application | 
| Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin 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). | Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application | 
| Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin 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). | Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Adverse events were assessed at each visit and during the follow up phone call on Day 28. | Day 1 up Day 28 post-application | 
| Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin. | Eradication of live lice was assessed by visual examination of the scalp and hair. | Day 2, Day 8 and Day 15 post-application | 
| Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin. | Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin. | Day 2, Day 8 and Day 15 post-application | 
| Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 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. | Day 1, Day 2, Day 8 and Day 15 post-application | 
| Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 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. | Day 1, Day 2, Day 8 and Day 15 post-application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head Lice, Pediculus