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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides.
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.
Secondary ID [1] 0 0
MOOV-1 Version 1 22 Sep 2004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediculosis 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

Study type
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)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Absence of live head lice one day after the first treatment of each product
Timepoint [1] 0 0

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

- 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.
Minimum age
5 Years
Maximum age
12 Years
Both males and females
Can healthy volunteers participate?
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

- Subjects must have one fixed place of residence

Study design
Purpose of the study
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?

Intervention assignment
Other design features
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Uniquest Pty Ltd
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Ego Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief summary

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Stephen Barker, PhD
Address 0 0
The University of Queensland
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
Other publications