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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00731718
Other study ID # LS/LB-001
Secondary ID IRB 008018
Status Completed
Phase N/A
First received April 23, 2008
Last updated August 8, 2008
Start date June 2007
Est. completion date July 2008

Study information

Verified date August 2008
Source Larada Sciences, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 543
Est. completion date July 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 6 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Larada Sciences,Inc. Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Larada Sciences, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of using heated air to kill head lice and their eggs Through out Yes
Secondary Safety of device Through out Yes
See also
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Completed NCT00927472 - Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice Phase 3
Completed NCT01336647 - An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation Phase 2