A Phase 2/3 interventional study of 1) MOOV Head Lice Treatment (Ego Pharmaceutical). and Banlice Mousse Aerosol (Pfizer, Australia) in Pediculosis, sponsored by Uniquest Pty Ltd. Completed at 1 site in Australia. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-12-12.
Sponsored by Uniquest Pty Ltd · Phase 2/3, Interventional, and Treatment
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.
All products were used according to the manufacturer's instructions. KP24 and Banlice were applied twice separated by a one week interval. MOOV Head Lice Treatment was applied on Day 0, Day 7 and Day 14. The cure rate (absence of live lice) one day after the first administration for all products was a secondary outcome measure. The cure rate at 7 days after the final administration (Day 14 for Banlice or KP24 and at Day 21 for MOOV Head Lice Treatment) was the primary outcome measure. Siblings were treated if these were found to be infected as an enrolment criteria.
58 studies on the registry are indexed under Lice Infestations; 4 are open to participants now.
This study's enrollment of 152 is above the median of 118 across 56 interventional studies indexed under Lice Infestations.
Browse Lice Infestations studies →This is the only study on the registry with Uniquest Pty Ltd as lead sponsor.
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Exclusion Criteria:
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)
Absence of live head lice one day after the first treatment of each product
This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.
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