Back to resultsControl of Head Lice Infestations in Children and Adults
Primary Purpose
Pediculosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lousebuster
Sponsored by
About this trial
This is an interventional treatment trial for Pediculosis focused on measuring Head Lice
Eligibility 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
Sites / Locations
- Larada Sciences,Inc.
Outcomes
Primary Outcome Measures
Efficacy of using heated air to kill head lice and their eggs
Secondary Outcome Measures
Safety of device
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00731718
Brief Title
Control of Head Lice Infestations in Children and Adults
Official Title
Control of Head Lice in Children and Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Larada Sciences, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediculosis
Keywords
Head Lice
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
543 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
lousebuster
Intervention Description
Subject serves as own control the length of treatment is approximately 30 minutes for full head treatment
Primary Outcome Measure Information:
Title
Efficacy of using heated air to kill head lice and their eggs
Time Frame
Through out
Secondary Outcome Measure Information:
Title
Safety of device
Time Frame
Through out
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale Clayton, PhD/Biology
Organizational Affiliation
Larada Sciences Inc., University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Larada Sciences,Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17079567
Citation
Goates BM, Atkin JS, Wilding KG, Birch KG, Cottam MR, Bush SE, Clayton DH. An effective nonchemical treatment for head lice: a lot of hot air. Pediatrics. 2006 Nov;118(5):1962-70. doi: 10.1542/peds.2005-1847.
Results Reference
background
PubMed Identifier
21337950
Citation
Bush SE, Rock AN, Jones SL, Malenke JR, Clayton DH. Efficacy of the LouseBuster, a new medical device for treating head lice (Anoplura:Pediculidae). J Med Entomol. 2011 Jan;48(1):67-72. doi: 10.1603/me10122.
Results Reference
derived
Links:
URL
http://headlice.org
Description
National Pediculosis Association
Learn more about this trial
Control of Head Lice Infestations in Children and Adults
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