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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00381082
Study type Interventional
Source Uniquest Pty Ltd
Contact
Status Completed
Phase Phase 2/Phase 3
Start date September 2004
Completion date November 2004

See also
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Completed NCT00752973 - Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice Phase 2/Phase 3
Completed NCT00545753 - Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice Phase 3
Terminated NCT02499549 - Two Treatment Regimens of Cocamide DEA Lotion for Head Lice Phase 2/Phase 3
Completed NCT05643820 - Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis Phase 1
Completed NCT00731718 - Control of Head Lice Infestations in Children and Adults N/A
Not yet recruiting NCT01966965 - Efficacy and Safety Study for PIOLIN® Shampoo Phase 3
Completed NCT00927407 - Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice Phase 1
Completed NCT01518699 - Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers Phase 1
Completed NCT00207753 - Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections N/A
Completed NCT00963508 - Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice Phase 3
Completed NCT00927472 - Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice Phase 3
Completed NCT01336647 - An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation Phase 2