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

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 to primary school-aged children

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000884202

Enrollment

Registered

2009-10-12

Start date

2009-10-16

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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. 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.

Interventions

Head lice products are applied to the hair and massaged in. A single application is used. GROUP 1: NeutraLice Lotion (containing Melaleuca Oil (Tea Tree Oil) 10% and Lavender Oil 1% - Key Pharmaceuticals Pty. Ltd.); GROUP 2: NeutraLice Advance (a suffocating product containing benzyl alcohol, mineral oil, polysorbate 80, sorbitan monooleate, Carbopol 934 and triethanolamine – Key Pharmaceuticals Pty. Ltd.)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Yes

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).

Outcome results