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Trial registered on ANZCTR


Registration number
ACTRN12607000564459
Ethics application status
Approved
Date submitted
30/10/2007
Date registered
1/11/2007
Date last updated
20/10/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, assessor blind, comparative trial of MOOV (reg. trade mark) Lotion, MOOV (reg. trade mark) Shampoo and KP24 Medicated Foam in the treatment of head lice in children
Scientific title
A randomised, assessor blind, comparative trial of MOOV Lotion, MOOV Shampoo and KP24 Medicated Foam in the treatment of head lice in children as measured by the elimination of head lice after 3 weekly treatments
Secondary ID [1] 489 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
head lice 2517 0
Condition category
Condition code
Skin 2612 2612 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1% (w/w) by weight malathione, eucalyptus oil or natural oils applied 3 times at weekly intervals
Intervention code [1] 2243 0
Treatment: Drugs
Comparator / control treatment
1% w/w malathione applied 3 times at weekly intervals
Control group
Active

Outcomes
Primary outcome [1] 3525 0
The primary efficacy endpoint will be the louse free rate at Day 21 for KP24 Medicated Foam, MOOV Shampoo and MOOV Lotion, as diagnosed by wet-combing of the hair and scalp in the intention-to-treat population.
Timepoint [1] 3525 0
presence of head lice at Day 21
Secondary outcome [1] 5879 0
a) the louse free rate at Day 21 for PP subjects treated with KP24 Medicated Foam verses MOOV Shampoo or MOOV Lotion.
b) the presence of head lice at Day 1, as diagnosed by dry-combing of the hair and scalp, for intention-to-treat and per-protocol subjects treated with KP24 Medicated Foam verses MOOV Shampoo or MOOV Lotion.
Timepoint [1] 5879 0
presence of head lice at Day 1 and Day 21

Eligibility
Key inclusion criteria
• Male or female primary school-aged 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 detected. The presence of lice eggs alone is not a sufficient condition for inclusion in the trial.
• Available for the duration of the trial.
• Parent / Guardian have 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 4 weeks prior to participation in this trial.
• Treatment with any head lice product during the trial.
• Treatment with a head lice comb during the trial if the subject is found to be louse free at Day 21 for any of the three treatment arms.
• Presence of scalp disease(s).
• If the subject has a sibling in Grade 1-7, who lived at the same residence during the treatment period the sibling must be examined for lice and if infested, enrolled in this study or wet combed out on days 0, 7 and 14, relative to the subject.
• Subjects must have one fixed place of residence during the trial.

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 to treatment was concealed by a single staff member and provided as required on application
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
the randomisation sequence was computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
252
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2758 0
Commercial sector/Industry
Name [1] 2758 0
Ego Pharmaceuticals Pty. Ltd.
Country [1] 2758 0
Australia
Funding source category [2] 2759 0
Commercial sector/Industry
Name [2] 2759 0
Ego Pharmaceuticals Pty. Ltd.
Country [2] 2759 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ego Pharmaceuticals Pty. Ltd.
Address
21 – 31 Malcolm Road, Braeside Victoria 3195 Australia
Country
Australia
Secondary sponsor category [1] 2492 0
None
Name [1] 2492 0
Address [1] 2492 0
Country [1] 2492 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4679 0
University of Queensland
Ethics committee address [1] 4679 0
University of Queensland
Brisbane, Qld.
Ethics committee country [1] 4679 0
Australia
Date submitted for ethics approval [1] 4679 0
27/07/2007
Approval date [1] 4679 0
01/08/2007
Ethics approval number [1] 4679 0
2003000184

Summary
Brief summary
All head lice products will be applied on Day 0, Day 7 and Day 14. The combing procedure normally used in combination with KP24 Medicated Foam will not be performed in order to compare the efficacy of the components of each product without confounding the efficacy measurements by physically removing head lice by combing.

The louse free rate (see glossary) at Day 21 after 3 applications of all three treatments will be determined by wet combing for the Intention to Treat population (primary outcome measure) and the Per Protocol population (secondary outcome measure). The louse free rate at Day 1 will be determined by dry combing (secondary outcome measure).
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 28155 0
Address 28155 0
Country 28155 0
Phone 28155 0
Fax 28155 0
Email 28155 0
Contact person for public queries
Name 11312 0
Dr. Kerryn Grieve
Address 11312 0
Ego Pharmaceuticals Pty. Ltd.
21 – 31 Malcolm Road, Braeside Victoria 3195
Country 11312 0
Australia
Phone 11312 0
(03) 95868874
Fax 11312 0
(03) 95807647
Email 11312 0
[email protected]
Contact person for scientific queries
Name 2240 0
Dr. Kerryn Grieve
Address 2240 0
Ego Pharmaceuticals Pty. Ltd.
21 – 31 Malcolm Road, Braeside Victoria 3195
Country 2240 0
Australia
Phone 2240 0
(03) 95868874
Fax 2240 0
(03) 95807647
Email 2240 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.