- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00381082
A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides.
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.
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Queensland
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Brisbane, Queensland, Australia, 4072
- University of Queensland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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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Secondary Outcome Measures
Outcome Measure |
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Absence of live head lice one day after the first treatment of each product
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen Barker, PhD, The University of Queensland
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOOV-1 Version 1 22 Sep 2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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