Trial registered on ANZCTR


Trial ID
ACTRN12609000884202
Ethics application status
Approved
Date submitted
9/10/2009
Date registered
12/10/2009
Type of registration
Prospectively registered

Titles & IDs
Public 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
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 to primary school-aged children
Secondary ID [1] 1110 0
KEY/NL/003
Universal Trial Number (UTN)
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
head lice infestation 251968 0
Condition category
Condition code
Skin 252158 252158 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Head lice products are applied to the hair and massaged in. A single application is used.

GROUP 1:
NeutraLice Lotion (containing Melaleuca Oil (Tea Tree Oil) 10% and Lavender Oil 1% - Key Pharmaceuticals Pty. Ltd.);

GROUP 2:
NeutraLice Advance (a suffocating product containing benzyl alcohol, mineral oil, polysorbate 80, sorbitan monooleate, Carbopol 934 and triethanolamine – Key Pharmaceuticals Pty. Ltd.)
Intervention code [1] 241381 0
Treatment: drugs
Comparator / control treatment
GROUP 3:
Moov Head Lice Solution (containing Eucalyptus oil 11% and Lemon Tea Tree Oil 1% - Ego Pharmaceuticals Pty. Ltd.)
Control group
Active

Outcomes
Primary outcome [1] 253027 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] 253027 0
14 days after collection of eggs
Secondary outcome [1] 257841 0
Nil
Timepoint [1] 257841 0
Nil

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
No limit
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 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)
allocation schedule held by trial manager off site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
16/10/2009
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Target sample size
90
Actual sample size
Recruitment status
Completed
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243850 0
Commercial sector/Industry
Name [1] 243850 0
Key Pharmaceuticals Pty. Ltd.
Address [1] 243850 0
12 Lyonpark Rd., Macquarie Park, NSW 2113
Country [1] 243850 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Key Pharmaceuticals Pty. Ltd.
Address
12 Lyonpark Rd., Macquarie Park, NSW 2113
Country
Australia
Secondary sponsor category [1] 237205 0
None
Name [1] 237205 0
NA
Address [1] 237205 0
NA
Country [1] 237205 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243966 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 243966 0
University of Queensland
St. Lucia, Brisbane Qld. 4072
Ethics committee country [1] 243966 0
Australia
Date submitted for ethics approval [1] 243966 0
07/09/2009
Approval date [1] 243966 0
07/10/2009
Ethics approval number [1] 243966 0
2003000184

Summary
Brief summary
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.

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30360 0
Address 30360 0
Country 30360 0
Phone 30360 0
Fax 30360 0
Email 30360 0
Contact person for public queries
Name 13607 0
Phillip Altman
Address 13607 0
152 Cammeray Rd.
Cammeray, NSW 2062
Country 13607 0
Australia
Phone 13607 0
+61 (02)99088881
Fax 13607 0
+61 (02)99081617
Email 13607 0
Pmaltman@bigpond.net.au
Contact person for scientific queries
Name 4535 0
Phillip Altman
Address 4535 0
152 Cammeray Rd.
Cammeray, NSW 2062
Country 4535 0
Australia
Phone 4535 0
+61 (02)99088881
Fax 4535 0
+61 (02)99081617
Email 4535 0
pmaltman@bigpond.net.au