A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides.

NCT ID: NCT00381082

Last Updated: 2006-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2004-11-30

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.

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

Keywords

Pediculus; capitis; lice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

1) MOOV Head Lice Treatment (Ego Pharmaceutical).

Intervention Type: DRUG

Banlice Mousse Aerosol (Pfizer, Australia)

Intervention Type: DRUG

3) KP24 Medicated Foam (Nelson Laboratories)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ego Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Uniquest Pty Ltd

OTHER

Sponsor Role: lead

Principal Investigators

Stephen Barker, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

Locations

University of Queensland

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

MOOV-1 Version 1 22 Sep 2004

Identifier Type: -

Identifier Source: org_study_id