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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Topaz Pharmaceuticals Inc
• Treatments: Ivermectin

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.