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

Condition(s) targeted: Head Lice

Intervention: 0.5% Ivermectin Cream (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Topaz Pharmaceuticals Inc

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Topaz

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: 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 design: Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points

Summary of Pharmacokinetic Parameters Following Ivermectin Application.

Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.

Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.

Secondary outcome:

Number of Participants Reporting Adverse Events Following Ivermectin Treatment

Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.

Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.

Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application

Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application

Minimum age: 6 Months. Maximum age: 3 Years. Gender(s): Both.

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.

Children's Investigational Research Program, Bentonville, Arkansas 72712, United States

Universal BioPharma Research, Inc, Dinuba, California 93618, United States

Impact Clinical Trials, Los Angeles, California 90036, United States

Lice Source Solutions Inc, Plantation, Florida 33313, United States

Spence Medical Research L.L.C, Picayune, Mississippi 39466, United States

Starting date: September 2009
Last updated: March 30, 2012