Control of Head Lice Infestations in Children and Adults

This study has been completed.
Sponsor:
Information provided by:
Larada Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT00731718
First received: April 23, 2008
Last updated: August 8, 2008
Last verified: August 2008
  Purpose

The goal of this study is to see if heated air will kill head lice and their eggs. The treatment visit is approximately 1 hour long with a follow up phone call.


Condition Intervention
Pediculosis
Device: lousebuster

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Control of Head Lice in Children and Adults

Resource links provided by NLM:


Further study details as provided by Larada Sciences, Inc.:

Primary Outcome Measures:
  • Efficacy of using heated air to kill head lice and their eggs [ Time Frame: Through out ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of device [ Time Frame: Through out ] [ Designated as safety issue: Yes ]

Enrollment: 543
Study Start Date: June 2007
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: lousebuster
    Subject serves as own control the length of treatment is approximately 30 minutes for full head treatment
Detailed Description:

Head lice strikes fear into the hearts of parents of school age children. Ridding a child of head lice is one of the most frustrating experiences a parent can face.

The objective of this project is to test whether louse desiccation using our prototype is an effective means of controlling head louse infestations in children.

Children age 6 and over are included in this study.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be at least 6 years old, male or female Parent to attend treatment Able to comb the hair with no problems

Exclusion Criteria:

  • Chemical shampoos used within 14 days Open sores or wounds on the scalp Recent head radiation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731718

Locations
United States, Utah
Larada Sciences,Inc.
Salt Lake City, Utah, United States, 84103
Sponsors and Collaborators
Larada Sciences, Inc.
Investigators
Principal Investigator: Dale Clayton, PhD/Biology Larada Sciences Inc., University of Utah
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dale Clayton, PhD, Larada Sciences, Inc.
ClinicalTrials.gov Identifier: NCT00731718     History of Changes
Other Study ID Numbers: LS/LB-001, IRB 008018
Study First Received: April 23, 2008
Last Updated: August 8, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Larada Sciences, Inc.:
Head Lice

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on April 20, 2014