ACTRN12607000564459CompletedPhase 4
A randomised, assessor blind, comparative trial of MOOV Lotion, MOOV Shampoo and KP24 Medicated Foam in the treatment of head lice in children as measured by the elimination of head lice after 3 weekly treatments
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 252
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 5 Years to 12 Years (—)
- Sex
- All
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.
Investigators
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