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

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

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.

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.