Trial from ANZCTR


Trial ID ACTRN12609000884202
Trial Status: Registered
Date Submitted: 9/10/2009
Date Registered: 12/10/2009
Prospectively registered

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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
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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
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Secondary ID [1] 1110 0
KEY/NL/003
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
head lice infestation 251968 0
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Condition category: Condition code:
Skin Dermatological conditions
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252158 252158 0 0

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Descriptions 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.)
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Intervention Code:
Treatment: drugs 241381 0
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Comparator / control treatment GROUP 3:
Moov Head Lice Solution (containing Eucalyptus oil 11% and Lemon Tea Tree Oil 1% - Ego Pharmaceuticals Pty. Ltd.)
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Control group Active
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Primary Outcome: 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.
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Timepoint: 14 days after collection of eggs 253027 0
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Secondary Outcome: Nil 257841 0
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Timepoint: Nil 257841 0
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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.
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Minimum age No limit
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? Yes
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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).
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) allocation schedule held by trial manager off site
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) computer software
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 4
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Anticipated date of first participant enrolment 16/10/2009
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 90
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Recruitment status Completed
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Commercial sector/Industry 243850 0
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Name: Key Pharmaceuticals Pty. Ltd. 243850 0
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Address: 12 Lyonpark Rd., Macquarie Park, NSW 2113 243850 0
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Country: Australia 243850 0
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Primary Sponsor Commercial sector/Industry
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Name: Key Pharmaceuticals Pty. Ltd.
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Address: 12 Lyonpark Rd., Macquarie Park, NSW 2113
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Country: Australia
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Secondary Sponsor: None 237205 0
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Name: NA 237205 0
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Address: NA 237205 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of Queensland Medical Research Ethics Committee 243966 0
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Address: University of Queensland
St. Lucia, Brisbane Qld. 4072
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Country: Australia 243966 0
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Approval Date: 07/10/2009 243966 0
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Submitted Date: 07/09/2009 243966 0
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HREC: 2003000184 243966 0
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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.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Phillip Altman
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Address: 152 Cammeray Rd. Cammeray, NSW 2062
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Country: Australia
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Tel: +61 (02)99088881
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Fax: +61 (02)99081617
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Email: Pmaltman@bigpond.net.au
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Contact person for scientific queries
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Name: Phillip Altman
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Address: 152 Cammeray Rd. Cammeray, NSW 2062
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Contact person responsible for updating information
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Name: Phillip Altman
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Address: 152 Cammeray Rd. Cammeray, NSW 2062
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Tel: +61 (02)99088881
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Addition Cancer fields
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