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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Topaz Pharmaceuticals Inc
- Enrollment
- 30
- Locations
- 5
- Primary Endpoint
- Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 3 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
0.5% Ivermectin Cream
Intervention: 0.5% Ivermectin Cream (Drug)
Outcomes
Primary Outcomes
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
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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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 Outcomes
- Number of Participants Reporting Adverse Events Following Ivermectin Treatment(Day 1 up Day 28 post-application)
- Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.(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.(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(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(Day 1, Day 2, Day 8 and Day 15 post-application)