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

Purpose

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	Intervention	Phase
Head Lice	Drug: 0.5% Ivermectin Cream	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Head Lice Lice Parasitic Diseases

Drug Information available for: Ivermectin

U.S. FDA Resources

Further study details as provided by Topaz Pharmaceuticals Inc:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 1 up Day 28 post-application ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 2, Day 8 and Day 15 post-application ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 2, Day 8 and Day 15 post-application ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 1, Day 2, Day 8 and Day 15 post-application ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 1, Day 2, Day 8 and Day 15 post-application ] [ Designated as safety issue: No ]
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.

Enrollment:	30
Study Start Date:	September 2009
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 0.5% Ivermectin Cream	Drug: 0.5% Ivermectin Cream Topical 0.5% ivermectin cream applied to scalp and hair on day 1

Eligibility

Ages Eligible for Study:	6 Months to 3 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988533

Locations

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

Sponsors and Collaborators

Topaz Pharmaceuticals Inc

Investigators

Study Director:

Medical Director

Sanofi Topaz

More Information

No publications provided

Responsible Party:	Topaz Pharmaceuticals Inc
ClinicalTrials.gov Identifier:	NCT00988533 History of Changes
Other Study ID Numbers:	TOP008
Study First Received:	October 1, 2009
Results First Received:	March 1, 2012
Last Updated:	March 30, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Topaz Pharmaceuticals Inc:

Head Lice
Pediculus

Additional relevant MeSH terms:

Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases

Ivermectin
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013