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

Sponsor:	Altman Biomedical Consulting Pty. Ltd.
Information provided by:	Altman Biomedical Consulting Pty. Ltd.
ClinicalTrials.gov Identifier:	NCT00995124

Purpose

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).

Condition	Intervention	Phase
Head Lice	Drug: NeutraLice Lotion Drug: NeutraLice Advance Solution Drug: Moov Head Lice Solution	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
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

Further study details as provided by Altman Biomedical Consulting Pty. Ltd.:

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. [ Time Frame: ovicidal activity assessed after 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	October 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
NeutraLice Lotion: Experimental Single application of head lice product.	Drug: NeutraLice Lotion Head lice topical application to be applied once for 10 minutes.
NeutraLice Advance: Experimental single application of head lice product	Drug: NeutraLice Advance Solution head lice application to be applied once for 10 minutes
Moov Head Lice Solution: Active Comparator 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.

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.

Eligibility

Ages Eligible for Study:	up to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995124

Contacts

Contact: Stephen Barker, PhD

+61 421695550

s.barker@uq.edu.au

Locations

Australia, New South Wales
Assoc. Prof. Stephen Barker	Recruiting
Brisbane, New South Wales, Australia, 4072
Contact: Stephen Barker, PhD +61 421695550 s.barker@uq.edu.au
Principal Investigator: Stephen Barker

Sponsors and Collaborators

Altman Biomedical Consulting Pty. Ltd.

Investigators

Principal Investigator:

Stephen Barker, PhD

University of Queensland, Queensland, Australia

More Information

No publications provided

Responsible Party:	Parasitology Section, School of Chemistry & Molecular Biosciences, & UniQuest Pty Ltd ( Assoc. Prof. Stephen Barker )
Study ID Numbers:	KEY/NL/003
Study First Received:	October 13, 2009
Last Updated:	October 14, 2009
ClinicalTrials.gov Identifier:	NCT00995124 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Altman Biomedical Consulting Pty. Ltd.:

ovicide
head lice infestation

Additional relevant MeSH terms:

Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Infectious

Skin Diseases
Skin Diseases, Parasitic
Parasitic Diseases

ClinicalTrials.gov processed this record on February 08, 2010