Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice… (NCT02062060) | Clinical Trial Compass
CompletedPhase 3
Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation
United States325 participantsStarted 2014-02
Plain-language summary
Purpose of this study is to evaluate the efficacy of at-home administration of a single application of abametapir lotion 0.74% w/w for the treatment of head lice.
Who can participate
Age range
6 Months
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
. Male or female, aged six months of age or older.
. Is in good general health based on medical history.
. Has active head lice infestation at Screening as determined by a trained evaluator with the exception of the male head of household who may self-assess as being lice-free. Active head lice infestation is defined as at least three live lice for the index subject and at least one live louse for the other household members.
. The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home.
. Belongs to a household with an eligible index subject with active head lice infestation.
. Agrees to an examination for head lice and to all visits and procedures throughout the study.
. Has signed an informed consent and/or assent form.
Exclusion criteria
. Had treatment (over-the-counter), home remedy or prescription medication) for head lice within 14 days prior to Day 0.
. Intends to use any other form of lice treatment from Day 0 through the Day 14 visit, unless provided as rescue therapy to this Protocol.
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 index subjects who are lice-free at all follow-up visits through to the Day 14 visit.
. Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol.
. Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit.
. Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment.
. Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data.
. Has visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is \>2, blisters, vesicles which, in the opinion of the investigative personnel or Sponsor, will interfere with safety and/or efficacy evaluations.