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Pediatric Head Lice Study Product Comparison

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ClinicalTrials.gov Identifier: NCT02213055
Recruitment Status : Completed
First Posted : August 11, 2014
Results First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hackensack University Medical Center

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.

Condition or disease Intervention/treatment Phase
Head Lice Drug: LICEMD Drug: Standard Head lice product Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of a 100% Dimethicone Pediculocide in School-Age Children
Study Start Date : May 2009
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: 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.
Drug: LICEMD
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.
Other Name: Generic Name: Dimethicone

Active Comparator: 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.
Drug: Standard Head lice product
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.
Other Names:
  • permethrin (5%)
  • malathion (0.5%)
  • lindane (1%)




Primary Outcome Measures :
  1. Number of Participants Free of Live Head Lice and Free of Viable Eggs [ Time Frame: 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.




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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213055


Locations
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack University Medical Center
Investigators
Principal Investigator: Lawrence Rosen, MD Hackensack University Medical Center
Study Director: Jeffrey Boscamp, MD Hackensack University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hackensack University Medical Center
ClinicalTrials.gov Identifier: NCT02213055     History of Changes
Other Study ID Numbers: Pro00000685
First Posted: August 11, 2014    Key Record Dates
Results First Posted: July 29, 2016
Last Update Posted: July 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The protocol and clinical dataset will be made available upon request to any scientist wishing to use them for non-commercial purposes.

Keywords provided by Hackensack University Medical Center:
Lice

Additional relevant MeSH terms:
Permethrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action