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

NCT00381082 | Completed Phase 2

• 1 other identifier: MOOV-1 Version 1 22 Sep 2004
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediculosis

Keywords

Pediculus; capitis; lice

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Absence of live head lice one day after the first treatment of each product

Interventions

1) MOOV Head Lice Treatment (Ego Pharmaceutical). DRUG

Banlice Mousse Aerosol (Pfizer, Australia) DRUG

3) KP24 Medicated Foam (Nelson Laboratories) DRUG

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female primary school children.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Uniquest Pty Ltd: lead
• Ego Pharmaceuticals: collaborator

Study Sites (1)

University of Queensland

Brisbane, Queensland, 4072, Australia

Location

MeSH Terms

Conditions

Lice Infestations

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Stephen Barker, PhD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 27, 2006
• Study Start: September 1, 2004
• Study Completion: November 1, 2004
• Last Updated: December 12, 2006

Record last verified: 2006-12

Locations

AU (1)