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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Head Lice

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0.5% Ivermectin Cream

Group Type EXPERIMENTAL

0.5% Ivermectin Cream

Intervention Type DRUG

Topical 0.5% ivermectin cream applied to scalp and hair on day 1

Interventions

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0.5% Ivermectin Cream

Topical 0.5% ivermectin cream applied to scalp and hair on day 1

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No