Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application
Primary Purpose
Head Lice
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
NeutraLice Lotion
NeutraLice Advance Solution
Moov Head Lice Solution
Sponsored by
About this trial
This is an interventional treatment trial for Head Lice focused on measuring ovicide, head lice infestation
Eligibility Criteria
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).
Sites / Locations
- Assoc. Prof. Stephen Barker
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
NeutraLice Lotion
NeutraLice Advance
Moov Head Lice Solution
Arm Description
Single application of head lice product.
single application of head lice product
Single application for head lice with 10 min application time.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00995124
First Posted
October 13, 2009
Last Updated
July 26, 2010
Sponsor
Altman Biomedical Consulting Pty. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00995124
Brief Title
Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Altman Biomedical Consulting Pty. Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Lice
Keywords
ovicide, head lice infestation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NeutraLice Lotion
Arm Type
Experimental
Arm Description
Single application of head lice product.
Arm Title
NeutraLice Advance
Arm Type
Experimental
Arm Description
single application of head lice product
Arm Title
Moov Head Lice Solution
Arm Type
Active Comparator
Arm Description
Single application for head lice with 10 min application time.
Intervention Type
Drug
Intervention Name(s)
NeutraLice Lotion
Intervention Description
Head lice topical application to be applied once for 10 minutes.
Intervention Type
Drug
Intervention Name(s)
NeutraLice Advance Solution
Intervention Description
head lice application to be applied once for 10 minutes
Intervention Type
Drug
Intervention Name(s)
Moov Head Lice Solution
Intervention Description
Single application for head lice with 10 min application time.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Barker, PhD
Organizational Affiliation
University of Queensland, Queensland, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assoc. Prof. Stephen Barker
City
Brisbane
State/Province
New South Wales
ZIP/Postal Code
4072
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application
We'll reach out to this number within 24 hrs