A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age
Condition: Head Lice
MeSH terms: Lice Infestations
Intervention: 0.5% Ivermectin Cream
Intervention description: Topical 0.5% ivermectin cream applied to scalp and hair on day 1
Intervention MeSH terms: Ivermectin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 6 Months
Maximum age: 3 Years
Healthy volunteers: No
Keywords: Head Lice; Pediculus

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.
    

Eligibility 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.