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
1 other identifier
interventional
90
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 13, 2009
CompletedFirst Posted
Study publicly available on registry
October 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJuly 28, 2010
July 1, 2010
2 months
October 13, 2009
July 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
NeutraLice Lotion
EXPERIMENTALSingle application of head lice product.
NeutraLice Advance
EXPERIMENTALsingle application of head lice product
Moov Head Lice Solution
ACTIVE COMPARATORSingle application for head lice with 10 min application time.
Interventions
Head lice topical application to be applied once for 10 minutes.
head lice application to be applied once for 10 minutes
Single application for head lice with 10 min application time.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assoc. Prof. Stephen Barker
Brisbane, New South Wales, 4072, Australia
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Barker, PhD
University of Queensland, Queensland, Australia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 13, 2009
First Posted
October 15, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
July 28, 2010
Record last verified: 2010-07