Pediatric Head Lice Study Product Comparison

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head Lice

Intervention / Treatment
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* Drug: LICEMD
* Drug: Standard Head lice product


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LICEMD<br>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. | Drug: LICEMD<br>* Parents/guardians of infested children will provide consent for their child's participation. 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. Participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application.<br>* Other names: Generic Name: Dimethicone;|
| Active Comparator: Standard Head lice product<br>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. | Drug: Standard Head lice product<br>* The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products.After baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may purchase any other head lice treatment of their choice. All treatments are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any examination, the school nurse will instruct the parent/guardian to retreat.<br>* Other names: lindane (1%);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Free of Live Head Lice and Free of Viable Eggs | 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. | Day after first treatment and Day 14 of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lice