MedTrace Logo

Pediatric Head Lice Study Product Comparison

NCT02213055 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2016-07-29

Study results available
· View outcomes & findings →

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.

Conditions

  • Head Lice

Interventions

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.

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.

Sponsors & Collaborators

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Lawrence Rosen, MD · Hackensack Meridian Health

  • Jeffrey Boscamp, MD · Hackensack Meridian Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02213055 on ClinicalTrials.gov