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

October 13, 2009
July 26, 2010
October 2009
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00995124 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application
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

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Head Lice
  • Drug: NeutraLice Lotion
    Head lice topical application to be applied once for 10 minutes.
  • Drug: NeutraLice Advance Solution
    head lice application to be applied once for 10 minutes
  • Drug: Moov Head Lice Solution
    Single application for head lice with 10 min application time.
  • Experimental: NeutraLice Lotion
    Single application of head lice product.
    Intervention: Drug: NeutraLice Lotion
  • Experimental: NeutraLice Advance
    single application of head lice product
    Intervention: Drug: NeutraLice Advance Solution
  • Active Comparator: Moov Head Lice Solution
    Single application for head lice with 10 min application time.
    Intervention: Drug: Moov Head Lice Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 2009
December 2009   (final data collection date for primary outcome measure)

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).
Both
up to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00995124
KEY/NL/003
No
Assoc. Prof. Stephen Barker, Parasitology Section, School of Chemistry & Molecular Biosciences, & UniQuest Pty Ltd
Altman Biomedical Consulting Pty. Ltd.
Not Provided
Principal Investigator: Stephen Barker, PhD University of Queensland, Queensland, Australia
Altman Biomedical Consulting Pty. Ltd.
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP