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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 25, 2014