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NCT00731718 Clinical Trial

Control of Head Lice Infestations in Children and Adults

Pediculosis Clinical Trial

Official title:
Control of Head Lice in Children and Adults

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
  Status Clinical Trial Phase
Completed NCT01660321 - Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation Phase 4
Completed NCT00752973 - Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice Phase 2/Phase 3
Completed NCT00545753 - Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice Phase 3
Completed NCT00381082 - A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides. Phase 2/Phase 3
Terminated NCT02499549 - Two Treatment Regimens of Cocamide DEA Lotion for Head Lice Phase 2/Phase 3
Completed NCT05643820 - Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis Phase 1
Not yet recruiting NCT01966965 - Efficacy and Safety Study for PIOLIN® Shampoo Phase 3
Completed NCT00927407 - Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice Phase 1
Completed NCT01518699 - Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers Phase 1
Completed NCT00207753 - Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections N/A
Completed NCT00927472 - Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice Phase 3
Completed NCT00963508 - 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

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