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Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application

This study has been completed.
Sponsor:
Information provided by:
Altman Biomedical Consulting Pty. Ltd.
ClinicalTrials.gov Identifier:
NCT00995124
First received: October 13, 2009
Last updated: July 26, 2010
Last verified: July 2010
History of Changes
  Purpose

The purpose of this study is to compare the ovicidal activity of three head lice treatment products.

The study population will consist of Queensland primary school-aged children (Grades 1 - 7) who have at least 20 live eggs on the hair and who have not used any head lice product in the four weeks prior to the study.

Enrollment will continue to achieve 30 subjects in each treatment group (total of 90 subjects).


Condition Intervention Phase
Head Lice
 Drug: NeutraLice Lotion
Drug: NeutraLice Advance Solution
Drug: Moov Head Lice Solution
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Assessor Blind, Parallel Group, Comparative Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Altman Biomedical Consulting Pty. Ltd.:

Primary Outcome Measures:
  • Ovicidal efficacy index (OEI) The proportion of treated eggs hatched in-vitro divided by the proportion of pre-treated eggs hatched in-vitro expressed as a percentage up to and including 14 days after collection and incubation. [ Time Frame: ovicidal activity assessed after 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NeutraLice Lotion
Single application of head lice product.
 Drug: NeutraLice Lotion
Head lice topical application to be applied once for 10 minutes.
Experimental: NeutraLice Advance
single application of head lice product
 Drug: NeutraLice Advance Solution
head lice application to be applied once for 10 minutes
Active Comparator: Moov Head Lice Solution
Single application for head lice with 10 min application time.
 Drug: Moov Head Lice Solution
Single application for head lice with 10 min application time.

Detailed Description:

Subjects will be examined for the presence of head louse eggs. Those subjects who have at least 20 live eggs will be randomised into one of 3 treatment groups: NeutraLice Lotion, NeutraLice Advance or Moov Head Lice Solution treatment groups.

Pre-treatment: 10 eggs will be removed from the head by cutting the single hair with the live egg attached, before the treatment.

Treatment: The subject will then receive a single treatment application according to manufacturers instructions. Then the treatment will be washed from the hair as per the manufacturer's instructions.

Post-treatment: At least 10 treated (live) eggs will be removed from the head by cutting the single hair with the egg attached, after the treatment.

All of the eggs will be held in an incubator for 14 days. The proportion of eggs which hatch after 14 days will be compared for the pre-treatment and post-treatment eggs. Demographic data will be collected for each subject (hair type, hair colour, hair length, subject age, subject sex) to investigate the affect of hair type on ovicidal efficacy.

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female primary school-aged children.
  • Presence of at least 20 live head lice eggs on the hair. The presence of live head lice eggs will be determined from a visual inspection of the hair.
  • Parent / Guardian have given written informed consent to their child's participation in the trial.

Exclusion Criteria:

  • History of allergies or adverse reactions to head lice products or the components of the specific products being tested.
  • Treatment with any head lice product in the 4 weeks prior to participation in this trial.
  • Treatment with hair dyes and bleaches within 4 weeks prior to participation in this trial.
  • Presence of scalp disease(s).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995124

Locations
Australia, New South Wales
Assoc. Prof. Stephen Barker
Brisbane, New South Wales, Australia, 4072
Sponsors and Collaborators
Altman Biomedical Consulting Pty. Ltd.
Investigators
Principal Investigator: Stephen Barker, PhD University of Queensland, Queensland, Australia
  More Information

No publications provided

Responsible Party: Assoc. Prof. Stephen Barker, Parasitology Section, School of Chemistry & Molecular Biosciences, & UniQuest Pty Ltd
ClinicalTrials.gov Identifier: NCT00995124     History of Changes
Other Study ID Numbers: KEY/NL/003
Study First Received: October 13, 2009
Last Updated: July 26, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Altman Biomedical Consulting Pty. Ltd.:
ovicide
head lice infestation

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
 Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013