Pediatric Head Lice Study Product Comparison

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

• 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.

Study Overview

• Status: Completed
• Conditions: Head Lice
• Intervention / Treatment: Drug: LICEMD; Drug: Standard Head lice product

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
• Enrollment (Actual): 97
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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%)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Investigators: Principal Investigator: Lawrence Rosen, MD, Hackensack Meridian Health; Study Director: Jeffrey Boscamp, MD, Hackensack Meridian Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 7, 2014
• First Posted (Estimate): August 11, 2014

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: June 20, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Lice
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Permethrin; Malathion
• Other Study ID Numbers: Pro00000685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The protocol and clinical dataset will be made available upon request to any scientist wishing to use them for non-commercial purposes.