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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00995124




Registration number
NCT00995124
Ethics application status
Date submitted
13/10/2009
Date registered
15/10/2009
Date last updated
28/07/2010

Titles & IDs
Public title
Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application
Scientific 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
Secondary ID [1] 0 0
KEY/NL/003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head Lice 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NeutraLice Lotion
Treatment: Drugs - NeutraLice Advance Solution
Treatment: Drugs - Moov Head Lice Solution

Experimental: NeutraLice Lotion - Single application of head lice product.

Experimental: NeutraLice Advance - single application of head lice product

Active Comparator: Moov Head Lice Solution - Single application for head lice with 10 min application time.


Treatment: Drugs: NeutraLice Lotion
Head lice topical application to be applied once for 10 minutes.

Treatment: Drugs: NeutraLice Advance Solution
head lice application to be applied once for 10 minutes

Treatment: Drugs: Moov Head Lice Solution
Single application for head lice with 10 min application time.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
ovicidal activity assessed after 14 days

Eligibility
Key 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.
Minimum age
No limit
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Assoc. Prof. Stephen Barker - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Altman Biomedical Consulting Pty. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00995124
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Barker, PhD
Address 0 0
University of Queensland, Queensland, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00995124