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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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.
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
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

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.
Minimum age
5 Years
Maximum age
12 Years
Sex
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 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

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)
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2004
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)
QLD
Recruitment hospital [1] 0 0
University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Uniquest Pty Ltd
Address
Country
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

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.
Trial website
https://clinicaltrials.gov/study/NCT00381082
Trial related presentations / publications
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00381082