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 range
3 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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