Pediatric Head Lice Study Product Comparison

Safety and Efficacy of a 100% Dimethicone Pediculocide in School-Age Children

• To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric population.
• To evaluate the safety of LiceMD in a pediatric population.

Head lice, or Pediculus humanus capitis, cause an estimated 6 to 12 million infestations per year in the U.S., most commonly affecting children 3 to 11 years of age. Despite common perceptions, head lice crawl, and cannot hop or fly. For this reason, transmission occurs most often by human head-to-head contact, and much less commonly by the sharing of personal items such as hats, coats, combs, or towels. Because head lice feed on human blood, they cannot live on pets and are only viable 1-2 days on surfaces other than the human head.

Inclusion Criteria:

• Subject Inclusion Criteria
• Current lice infestation, confirmed by school nurse. Must have live lice - not just eggs. A minimum of one live louse and 10 viable eggs must be seen or three live lice.
• Male or female child; age 3 - 12
• Willing to participate in study, and parent/guardian sign informed consent
• Parent/guardian must be able to read and follow directions and complete all questionnaires
• For children/parents who agree to the experimental arm of the study, agree not to use any other head lice product or home remedy lice treatment during the study.

Exclusion Criteria:

• No live lice, only eggs.
• Less than three live lice observed with less than ten viable eggs
• No hair on the head
• Buzz cut or crew cut
• Use of other lice treatment or home remedy lice treatment within the past 4 weeks
• Chronic scalp disorder (such as psoriasis) that would limit the school nurse's ability to detect lice and/or identify adverse events
• Currently taking an antibiotic
• Does not follow instructions.