A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation

Inclusion Criteria

• •Index subjects must have an active head lice infestation defined as: At least 3 live lice (adults and/or nymphs) present on the scalp and/or hair, as determined by a trained evaluator. The index subject must be the youngest family member presenting with at least 3 live lice. After the index subject has been identified, additional infested household members (see b below) will be enrolled.
• •Household subjects must have an active head lice infestation defined as: At least 1 live louse (adult and/or nymph) present on the scalp and/or hair, as determined by a trained evaluator (with the exception of the male head of household who may self-assess as being lice free).
• •Subject is male or female.
• •Subject is at least 6 months of age at time of enrollment.
• •Subject is in good general health based on medical history.
• •Each subject must have an appropriately signed Informed Consent agreement. A caregiver must sign an Informed Consent agreement for children not old enough to do so. Children of a specified age will be administered a child's assent form.
• •The caregiver of a subject must be willing to allow all household members to be screened for head lice. If other household members are found to have an active head lice infestation, according to the criteria b (above), they must be willing and able to participate in the study. No more than one working male per household may be excluded from evaluation if he is assessed as being lice free by himself or the caregiver and cannot come in due to his work schedule. If this individual may have lice, he must come to the test facility; otherwise the entire household will be excluded from study participation.
• •Subject and/or their caregiver must be physically able and willing to apply the test article.
• •Subject agrees not to use any other form of lice treatments (commercial, community-anecdotal, or mechanical/manual) while participating in the study.
• •Following application and rinsing of the test article, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24-hour post-treatment evaluation has been completed.
• •Subject agrees to not cut or chemically treat their hair while participating in the study.
• •Subject agrees to follow all study instructions.
• •Female subjects of childbearing potential (including a female caregiver even if she is not being treated) must be willing to have a urine pregnancy test.
• •In the event of a subject judged to be incapable of self-treating, the household must have a caregiver willing to apply the treatment at home.