NCT00731718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
Last Updated

August 11, 2008

Status Verified

August 1, 2008

Enrollment Period

1 year

First QC Date

April 23, 2008

Last Update Submit

August 8, 2008

Conditions

Pediculosis

Keywords

Head Lice

Outcome Measures

Primary Outcomes (1)

  • Efficacy of using heated air to kill head lice and their eggs

    Through out

Secondary Outcomes (1)

  • Safety of device

    Through out

Interventions

lousebusterDEVICE

Subject serves as own control the length of treatment is approximately 30 minutes for full head treatment

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Chemical shampoos used within 14 days Open sores or wounds on the scalp Recent head radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Larada Sciences,Inc.

Salt Lake City, Utah, 84103, United States

Location

Related Publications (2)

  • 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.

    PMID: 17079567BACKGROUND

  • 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.

    PMID: 21337950DERIVED

Related Links

MeSH Terms

Conditions

Lice Infestations

Condition Hierarchy (Ancestors)

Ectoparasitic InfestationsSkin Diseases, ParasiticParasitic DiseasesInfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dale Clayton, PhD/Biology

    Larada Sciences Inc., University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 23, 2008

First Posted

August 11, 2008

Study Start

June 1, 2007

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

August 11, 2008

Record last verified: 2008-08

Locations

US(1)