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Pediatric Head Lice Study Product Comparison

Primary Purpose

Head Lice

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LICEMD
Standard Head lice product
Sponsored by
Hackensack Meridian Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Lice focused on measuring Lice

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hackensack University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LICEMD

Standard Head lice product

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2014
Last Updated
June 20, 2016
Sponsor
Hackensack Meridian Health
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1. Study Identification

Unique Protocol Identification Number
NCT02213055
Brief Title
Pediatric Head Lice Study Product Comparison
Official Title
Safety and Efficacy of a 100% Dimethicone Pediculocide in School-Age Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Lice
Keywords
Lice

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LICEMD
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Head lice product
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LICEMD
Other Intervention Name(s)
Generic Name: Dimethicone
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.
Intervention Type
Drug
Intervention Name(s)
Standard Head lice product
Other Intervention Name(s)
permethrin (5%), malathion (0.5%), lindane (1%)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Free of Live Head Lice and Free of Viable Eggs
Description
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.
Time Frame
Day after first treatment and Day 14 of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Rosen, MD
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Boscamp, MD
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Study Director
Facility Information:
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The protocol and clinical dataset will be made available upon request to any scientist wishing to use them for non-commercial purposes.
Citations:
PubMed Identifier
26092045
Citation
Ihde ES, Boscamp JR, Loh JM, Rosen L. Safety and efficacy of a 100% dimethicone pediculocide in school-age children. BMC Pediatr. 2015 Jun 20;15:70. doi: 10.1186/s12887-015-0381-0. Erratum In: BMC Pediatr. 2016;16:12.
Results Reference
derived

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Pediatric Head Lice Study Product Comparison

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