Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application

Head Lice Clinical Trial

Official title:

A Randomised, Assessor Blind, Parallel Group, Comparative Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995124
• Other study ID #: KEY/NL/003
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2009
• Last updated: July 26, 2010
• Start date: October 2009
• Est. completion date: December 2009

Study information

• Verified date: July 2010
• Source: Altman Biomedical Consulting Pty. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the ovicidal activity of three head lice treatment products.

The study population will consist of Queensland primary school-aged children (Grades 1 - 7) who have at least 20 live eggs on the hair and who have not used any head lice product in the four weeks prior to the study.

Enrollment will continue to achieve 30 subjects in each treatment group (total of 90 subjects).

Description:

Subjects will be examined for the presence of head louse eggs. Those subjects who have at least 20 live eggs will be randomised into one of 3 treatment groups: NeutraLice Lotion, NeutraLice Advance or Moov Head Lice Solution treatment groups.

Pre-treatment: 10 eggs will be removed from the head by cutting the single hair with the live egg attached, before the treatment.

Treatment: The subject will then receive a single treatment application according to manufacturers instructions. Then the treatment will be washed from the hair as per the manufacturer's instructions.

Post-treatment: At least 10 treated (live) eggs will be removed from the head by cutting the single hair with the egg attached, after the treatment.

All of the eggs will be held in an incubator for 14 days. The proportion of eggs which hatch after 14 days will be compared for the pre-treatment and post-treatment eggs. Demographic data will be collected for each subject (hair type, hair colour, hair length, subject age, subject sex) to investigate the affect of hair type on ovicidal efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

• Male or female primary school-aged children.

• Presence of at least 20 live head lice eggs on the hair. The presence of live head lice eggs will be determined from a visual inspection of the hair.

• Parent / Guardian have 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 4 weeks prior to participation in this trial.

• Treatment with hair dyes and bleaches within 4 weeks prior to participation in this trial.

• Presence of scalp disease(s).

Study Design

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

Related Conditions & MeSH terms

• Head Lice

Intervention

Drug:
• NeutraLice Lotion
Head lice topical application to be applied once for 10 minutes.
• NeutraLice Advance Solution
head lice application to be applied once for 10 minutes
• Moov Head Lice Solution
Single application for head lice with 10 min application time.

Locations

Country	Name	City	State
Australia	Assoc. Prof. Stephen Barker	Brisbane	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Altman Biomedical Consulting Pty. Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovicidal efficacy index (OEI) The proportion of treated eggs hatched in-vitro divided by the proportion of pre-treated eggs hatched in-vitro expressed as a percentage up to and including 14 days after collection and incubation.		ovicidal activity assessed after 14 days	No