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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Head Lice

Intervention / Treatment
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* Drug: NeutraLice Lotion
* Drug: NeutraLice Advance Solution
* Drug: Moov Head Lice Solution


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeutraLice Lotion<br>Single application of head lice product. | Drug: NeutraLice Lotion<br>* Head lice topical application to be applied once for 10 minutes.<br>|
| Experimental: NeutraLice Advance<br>single application of head lice product | Drug: NeutraLice Advance Solution<br>* head lice application to be applied once for 10 minutes<br>|
| Active Comparator: Moov Head Lice Solution<br>Single application for head lice with 10 min application time. | Drug: Moov Head Lice Solution<br>* Single application for head lice with 10 min application time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovicide, head lice infestation