NCT00995124

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Altman Biomedical Consulting Pty. Ltd. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

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).

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.

Conditions

• Head Lice

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-10-15
• Last updated: 2010-07-28

Locations

1 site across 1 country: Australia