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Trial registered on ANZCTR


Registration number
ACTRN12610000179033
Ethics application status
Approved
Date submitted
31/03/2009
Date registered
26/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, assessor blind, parallel group comparative trial of NeutraLice Lotion, NeutraLice Advance and Banlice Mousse in the treatment of head lice in children
Scientific title
A randomised, assessor blind, parallel group comparative trial of NeutraLice Lotion, NeutraLice Advance and Banlice Mousse in the treatment of head lice in children
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
head lice 4543 0
Condition category
Condition code
Skin 4833 4833 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NeutraLice Lotion (containing Melaleuca Oil [Tea Tree Oil] 10% and Lavender Oil 1% OR
NeutraLice Advance (containing 5% benzyl alcohol) OR
Banlice Mousse (aerosol containing pyrethrins 1.65 mg/g, and piperonyl butoxide 16.5 mg/g).
Banlice Mousse is weekly for 2 weeks and the other products are applied weekly for 3 weeks.
A generous amount of each head lice application is applied for 10 minutes and then rinsed out.
Intervention code [1] 4308 0
Treatment: Drugs
Comparator / control treatment
Banlice Mousse (aerosol containing pyrethrins 1.65 mg/g, and piperonyl butoxide 16.5 mg/g) - applied once weekly for 2 weeks
Control group
Active

Outcomes
Primary outcome [1] 5693 0
louse free rate in the intention-to-treat population determined by the wet combing technique
Timepoint [1] 5693 0
one day after last treatment
Secondary outcome [1] 241598 0
louse free rate at Day 1 as determined by the dry combing technique
Timepoint [1] 241598 0
one day after first treatment

Eligibility
Key inclusion criteria
Male or female primary school-aged children.
Presence of live head lice (adults or nymphs) on the hair or scalp. The presence of live lice will be determined from a visual inspection of the hair and scalp, and dry-combing of the hair. Combing will stop immediately once live lice are detected. The presence of lice eggs alone is not a sufficient condition for inclusion in the trial.
Available for the duration of the trial.
Parent / Guardian have given written informed consent to their child’s participation in the trial.
Minimum age
5 Years
Maximum age
12 Years
Gender
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 any head lice product during the trial.
Treatment with a head lice comb during the trial if the subject is found to be louse free on the final examination day.
Presence of scalp disease(s).
If the subject has a sibling in Grade 1-7, who lived at the same residence during the treatment period the sibling must be examined for lice and if infested, enrolled in this study or wet combed out on multiple days.
Subjects must have one fixed place of residence during the trial.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
siblings are treated with the same treatment as the enrolled child
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4739 0
Commercial sector/Industry
Name [1] 4739 0
Key Pharmaceuticals Ltd.
Address [1] 4739 0
12 Lyonpark Rd.
Macquarie Park
NSW 2113
Country [1] 4739 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
key Pharmaceuticals Ltd.
Address
12 Lyonpark Rd.
Macquarie Park, NSW 2113
Country
Australia
Secondary sponsor category [1] 4278 0
None
Name [1] 4278 0
Address [1] 4278 0
Country [1] 4278 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6779 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 6779 0
Medical Research Ethics Committee
Universityof Queensland
St. Lucia, Queensland 4072
Ethics committee country [1] 6779 0
Australia
Date submitted for ethics approval [1] 6779 0
Approval date [1] 6779 0
31/03/2009
Ethics approval number [1] 6779 0

Summary
Brief summary
NeutraLice Lotion, NeutraLice Advance and Banlice Mousse will be applied at weekly intervals.
The louse free rate one day after the last treatment will be determined by wet combing for the Intention to Treat population (primary outcome measure) and the Per Protocol population (secondary outcome measure). The louse free rate at Day 1 will be determined by dry combing (secondary outcome measure).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29450 0
Address 29450 0
Country 29450 0
Phone 29450 0
Fax 29450 0
Email 29450 0
Contact person for public queries
Name 12697 0
Phillip Altman
Address 12697 0
Altman Biomedical Consulting Pty. Ltd.
152 Cammeray Rd., Cammeray, NSW 2062
Country 12697 0
Australia
Phone 12697 0
+ 61 02 99088881
Fax 12697 0
+61 02 99081617
Email 12697 0
pmaltman@bigpond.net.au
Contact person for scientific queries
Name 3625 0
phillip Altman
Address 3625 0
Altman Biomedical Consulting Pty. Ltd.
152 Cammeray Rd., Cammeray, NSW 2062
Country 3625 0
Australia
Phone 3625 0
+61 02 99088881
Fax 3625 0
+61 02 9908 1617
Email 3625 0
pmaltman@bigpond.net.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary