Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects

Exclusion Criteria

• •History of irritation or sensitivity to ivermectin or the cream components, pediculicides or hair care products.
• •Presentation at the treatment site with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is \>2, blisters, vesicles which, in the opinion of the investigative personnel or sponsor, will interfere with safety and/or efficacy evaluations.
• •Presentation at the treatment site with eczema or atopic dermatitis on the skin/scalp.
• •Treatment with a marketed pediculicide (Over the counter \[OTC\] or Prescription) in the last 7 days.
• •Any condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol.
• •Is receiving any other treatment which, in the opinion of the investigator or study monitor, may interfere with the study results.
• •Females (including caregivers who come in contact with the investigational product) who are pregnant, nursing or planning a pregnancy. (NOTE: female caregivers and all enrolled females of childbearing potential must have a negative urine pregnancy test prior to treatment). If a household has a pregnant female who has an active case of lice, the entire household is excluded from participation. If this pregnant household member does not have an active infestation, this individual must NOT be the caregiver (one who provides treatment to other household members).
• •Is of child-bearing potential and unwilling to use an adequate method of contraception for the duration of the study. Adequate methods of contraception include: abstinence, vasectomized partner, oral birth control pills, birth control injections or patches, Intra Uterine Devices, condoms with a spermicidal jelly or a diaphragm with spermicidal jelly, surgical sterilization.
• •Participation in a previous investigational drug study within the past 30 days.
• •Does not understand the requirements for study participation and/or may likely exhibit poor compliance, in the opinion of the investigator.
• •Does not have a known household affiliation with their household members (i.e., do not stay in one household consistently, sleeping at one place several nights and then at another place or location). Household is defined as living in a shared area or space (for example the same house or apartment unit).