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

March 30, 2012 updated by: Topaz Pharmaceuticals Inc

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Children's Investigational Research Program
    • California
      • Dinuba, California, United States, 93618
        • Universal Biopharma Research, Inc
      • Los Angeles, California, United States, 90036
        • Impact Clinical Trials
    • Florida
      • Plantation, Florida, United States, 33313
        • Lice Source Solutions Inc
    • Mississippi
      • Picayune, Mississippi, United States, 39466
        • Spence Medical Research L.L.C

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 0.5% Ivermectin Cream
Drug: 0.5% Ivermectin Cream
Topical 0.5% ivermectin cream applied to scalp and hair on day 1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Before; 0.5, 1, 6, 24 hours and Up to 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).
Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 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).
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.
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).
Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Adverse Events Following Ivermectin Treatment
Time Frame: Day 1 up Day 28 post-application
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.
Time Frame: Day 2, Day 8 and Day 15 post-application
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.
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Day 1, Day 2, Day 8 and Day 15 post-application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Topaz Pharmaceuticals Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TOP008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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