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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/NCT00381082
Registration number
NCT00381082
Ethics application status
Date submitted
26/09/2006
Date registered
27/09/2006
Date last updated
12/12/2006
Titles & IDs
Public title
A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides.
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Scientific title
A Randomised, Controlled and Blinded Assessment Study of the Efficacy of MOOV Head Lice Treatment (Ego Pharmaceutical Pty. Ltd.) in the Treatment of Head Lice in Primary School Children.
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Secondary ID [1]
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MOOV-1 Version 1 22 Sep 2004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pediculosis
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Condition category
Condition code
Skin
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Other skin conditions
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Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 1) MOOV Head Lice Treatment (Ego Pharmaceutical).
Treatment: Drugs - Banlice Mousse Aerosol (Pfizer, Australia)
Treatment: Drugs - 3) KP24 Medicated Foam (Nelson Laboratories)
Treatment: Drugs: 1) MOOV Head Lice Treatment (Ego Pharmaceutical).
Treatment: Drugs: Banlice Mousse Aerosol (Pfizer, Australia)
Treatment: Drugs: 3) KP24 Medicated Foam (Nelson Laboratories)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Absence of live head lice one week after the last treatment for each product (ie at Day 14 for KP24 and Banlice and at Day 21 for MOOV Head Lice Treatment)
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Absence of live head lice one day after the first treatment of each product
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
- Male or female primary school 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 observed.
The presence of lice eggs alone is not a sufficient condition for inclusion in the
trial.
- Be available for the duration of the trial.
- Parent / Guardian is willing not to use other head lice products or methods (e.g.
combs) to treat their child's head lice for 21 days after the first treatment.
- Parent / Guardian has given written informed consent to their child's participation in
the trial.
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Minimum age
5
Years
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Maximum age
12
Years
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Sex
Both males and females
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Can healthy volunteers participate?
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 month prior to Day 0.
- Presence of scalp disease(s).
- If a subject has a sibling in Grade 1-7 this sibling must also be enrolled in the
study and treated on Day 0 otherwise the subject must be considered ineligible for
enrolment.
- Subjects must have one fixed place of residence
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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University of Queensland - Brisbane
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Recruitment postcode(s) [1]
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4072 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
Uniquest Pty Ltd
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Ego Pharmaceuticals
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Objective
To compare the cure rates (defined as the complete absence of live lice, adults or nymphs, as
diagnosed by wet-combing of three Australian approved head lice products for the treatment of
primary school children with head lice infestation. The study design will be randomised and
assessor-blind using three comparative parallel treatment groups.
The study population will consist of Queensland state primary school children (up to Year 7)
with live head lice (adults or nymphs) on the hair or scalp who have not used any head lice
product in the four weeks prior to the study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00381082
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stephen Barker, PhD
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Address
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The University of Queensland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00381082
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