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).

Study Overview

• Status: Completed
• Conditions: Head Lice
• Intervention / Treatment: Drug: NeutraLice Lotion; Drug: NeutraLice Advance Solution; Drug: Moov Head Lice Solution

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Brisbane, New South Wales, Australia, 4072
      • Assoc. Prof. Stephen Barker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	ovicidal activity assessed after 14 days

Collaborators and Investigators

• Sponsor: Altman Biomedical Consulting Pty. Ltd.
• Investigators: Principal Investigator: Stephen Barker, PhD, University of Queensland, Queensland, Australia

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: October 13, 2009
• First Submitted That Met QC Criteria: October 14, 2009
• First Posted (ESTIMATE): October 15, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 28, 2010
• Last Update Submitted That Met QC Criteria: July 26, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: ovicide; head lice infestation
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations; Pharmaceutical Solutions
• Other Study ID Numbers: KEY/NL/003