Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381082
Status:
COMPLETED
Last Update Posted:
2006-12-12
First Post:
2006-09-26
Brief Title:
A Randomised Assessor-Blind Comparative Efficacy Clinical Trial of 3 Pediculicides
Sponsor:
Uniquest Pty Ltd
Organization:
Uniquest Pty Ltd
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
All products were used according to the manufacturers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None