None listed
Conditions
Brief summary
All head lice products will be applied on Day 0, Day 7 and Day 14. The combing procedure normally used in combination with KP24 Medicated Foam will not be performed in order to compare the efficacy of the components of each product without confounding the efficacy measurements by physically removing head lice by combing. The louse free rate (see glossary) at Day 21 after 3 applications of all three treatments 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
1% (w/w) by weight malathione, eucalyptus oil or natural oils applied 3 times at weekly intervals
Sponsors
Ego Pharmaceuticals Pty. Ltd.
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 at Day 21 for any of the three treatment arms. • 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 days 0, 7 and 14, relative to the subject. • Subjects must have one fixed place of residence during the trial.
Outcome results
None listed