A randomised, assessor blind, parallel group comparative trial of NeutraLice Lotion, NeutraLice Advance and Banlice Mousse in the treatment of head lice in children

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000179033

Enrollment

120

Registered

2010-02-26

Start date

2009-04-21

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

NeutraLice Lotion, NeutraLice Advance and Banlice Mousse will be applied at weekly intervals. The louse free rate one day after the last treatment will be determined by wet combing for the Intention to Treat population (primary outcome measure) and the Per Protocol population (secondary outcome measure). The louse free rate at Day 1 will be determined by dry combing (secondary outcome measure).

Interventions

NeutraLice Lotion (containing Melaleuca Oil [Tea Tree Oil] 10% and Lavender Oil 1% OR NeutraLice Advance (containing 5% benzyl alcohol) OR Banlice Mousse (aerosol containing pyrethrins 1.65 mg/g, and piperonyl butoxide 16.5 mg/g). Banlice Mousse is weekly for 2 weeks and the other products are applied weekly for 3 weeks. A generous amount of each head lice application is applied for 10 minutes and then rinsed out.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

5 Years to 12 Years

Healthy volunteers

Yes

Inclusion criteria

Male or female primary school-aged 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 detected. The presence of lice eggs alone is not a sufficient condition for inclusion in the trial. Available for the duration of the trial. 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 any head lice product during the trial. Treatment with a head lice comb during the trial if the subject is found to be louse free on the final examination day. Presence of scalp disease(s). If the subject has a sibling in Grade 1-7, who lived at the same residence during the treatment period the sibling must be examined for lice and if infested, enrolled in this study or wet combed out on multiple days. Subjects must have one fixed place of residence during the trial.

Outcome results