search
Back to results

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

Primary Purpose

Head Lice

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
0.5% Ivermectin Cream
Sponsored by
Topaz Pharmaceuticals Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Lice focused on measuring Head Lice, Pediculus

Eligibility Criteria

6 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Investigational Research Program
  • Universal BioPharma Research, Inc
  • Impact Clinical Trials
  • Lice Source Solutions Inc
  • Spence Medical Research L.L.C

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

0.5% Ivermectin Cream

Arm Description

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
October 1, 2009
Last Updated
March 30, 2012
Sponsor
Topaz Pharmaceuticals Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT00988533
Brief Title
A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Topaz Pharmaceuticals Inc

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Lice
Keywords
Head Lice, Pediculus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5% Ivermectin Cream
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
0.5% Ivermectin Cream
Intervention Description
Topical 0.5% ivermectin cream applied to scalp and hair on day 1
Primary Outcome Measure Information:
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
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
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
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
Secondary Outcome Measure Information:
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
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Topaz
Official's Role
Study Director
Facility Information:
Facility Name
Children's Investigational Research Program
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Universal BioPharma Research, Inc
City
Dinuba
State/Province
California
ZIP/Postal Code
93618
Country
United States
Facility Name
Impact Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Lice Source Solutions Inc
City
Plantation
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
Spence Medical Research L.L.C
City
Picayune
State/Province
Mississippi
ZIP/Postal Code
39466
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs