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

Phase 4
Completed
Conditions
head lice
Skin - Dermatological conditions
Registration Number
ACTRN12610000179033
Lead Sponsor
key Pharmaceuticals Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
120
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
louse free rate in the intention-to-treat population determined by the wet combing technique[one day after last treatment]
Secondary Outcome Measures
NameTimeMethod
louse free rate at Day 1 as determined by the dry combing technique[one day after first treatment]
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