Efficacy and Safety of Topical 0.5% Ivermectin Lotion for the Treatment of Head Lice Infestation … (NCT03286101) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Topical 0.5% Ivermectin Lotion for the Treatment of Head Lice Infestation in Filipinos
Philippines120 participantsStarted 2017-09-14
Plain-language summary
This is a randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of a single application of 0.5% ivermectin lotion in Filipino subjects with head lice.
Who can participate
Age range3 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Index subjects must have an active lice infestation defined as: At least 3 live lice (adult and/or nymphs) present on the scalp and/or hair as determined by a trained evaluator; After the index subject has been enrolled, additional infested household members will be enrolled.
* Household subjects must have an active head lice infestation defined as: At least 1 live louse (adult and /or nymph) present on the scalp and/or hair, as determined by a trained evaluator (with the exception of the male head of household who may self- assess, as being lice free).
* Subject is male or female;
* Subject is at least 3 years old or older at the time of enrollment;
* Subject is in good general health based on the medical history;
* Each adult subject must have an appropriately signed Informed Consent agreement. For children, parents/guardian must sign an Informed Parental Consent agreement for children not old enough to do so. Children of a specified age will be administered a child's assent form
* The caregiver of a subject must be willing to allow all household members to be screened for head lice. If other household members are found to have an active head lice infestation, they must be willing and able to participate in the study. No more than one working male per household maybe excluded from evaluation if he is assessed as being lice free by himself or the caregiver and cannot come in due to his work schedule. If this individual may have lice, he must come to th…
What they're measuring
1
Proportion of participants cured of head lice infestation from their assigned product on day 2, day 8 and day 15 after the first treatment.
Timeframe: Day 2 to day 15 after product application