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

Completed · Phase 1

Conditions studied: Head Lice

In brief

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.

Key facts

Study ID

NCT00988533

Run by

Topaz Pharmaceuticals Inc

People needed

30

Starts

2009-09-01

Expected to finish

2009-11-01

Last updated by the study team

2012-04-25

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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