Pediatric Head Lice Study Product Comparison

Phase 2

Completed

Brief Summary: * 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
LICEMD	LICEMD	Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.
Standard Head lice product	Standard Head lice product	Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.

Primary Outcome Measures

Name	Time	Method
Number of Participants Free of Live Head Lice and Free of Viable Eggs	Day after first treatment and Day 14 of study	A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14. At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice.

Secondary Outcome Measures