Pediatric Head Lice Study Product Comparison
Condition: Head Lice
MeSH terms: Lice Infestations
Intervention: LICEMD; Standard Head lice product
Intervention description: 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.; 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.
Intervention MeSH terms: Permethrin; Malathion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 3 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Lice

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.
    

Eligibility criteria:

        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.