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NCT Number: NCT00995124

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).

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Key information

Conditions

Head Lice

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assoc. Prof. Stephen Barker

Brisbane, New South Wales, 4072, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

NeutraLice Lotion

Drug

Head lice topical application to be applied once for 10 minutes.

NeutraLice Advance Solution

Drug

head lice application to be applied once for 10 minutes

Moov Head Lice Solution

Drug

Single application for head lice with 10 min application time.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Altman Biomedical Consulting Pty. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 15, 2009
Registry last updated
Jul 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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