Status:
COMPLETED
Pediatric Head Lice Study Product Comparison
Lead Sponsor:
Hackensack Meridian Health
Conditions:
Head Lice
Eligibility:
All Genders
3-12 years
Phase:
PHASE2
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 l...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT02213055
Start Date
May 1 2009
End Date
August 1 2014
Last Update
July 29 2016
Active Locations (1)
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1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601