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.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 152 (planned)
• Sponsor: Uniquest Pty Ltd · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Pediculosis

Interventions

Type	Name	Description
DRUG	1) MOOV Head Lice Treatment (Ego Pharmaceutical).
DRUG	Banlice Mousse Aerosol (Pfizer, Australia)
DRUG	3) KP24 Medicated Foam (Nelson Laboratories)

Timeline

• Start date: 2004-09-01
• Completion: 2004-11-01
• First posted: 2006-09-27
• Last updated: 2006-12-12

Locations

1 site across 1 country: Australia