A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infesta… (NCT00528021) | Clinical Trial Compass
CompletedPhase 2
A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
United States230 participantsStarted 2007-08
Plain-language summary
The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.
Who can participate
Age range
2 Years – 70 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
. The subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent.
. Male or female subjects who are between the ages of 2 years (24 months) and 70 years old when consent is signed.
. Infestation with head lice as demonstrated by the presence of live lice prior to first treatment.
. Willing and able to attend all study visits as scheduled.
. Females of childbearing potential must have a negative urine pregnancy test at screening and before receiving a second treatment, if necessary.
Exclusion criteria
. Subject and/or legal guardian has not signed informed consent.
. Subject was treated for pediculosis within 2 weeks prior to the screening evaluation.
. Subject with an infestation of body lice or pubic lice.
. Subject is suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment, which in the opinion of the investigator and visiting physician could influence the results of the study.
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.
. Subject with other diagnoses which, in the opinion of the investigator, would interfere with efficacy or safety assessments or would preclude study participation.
. Subject with very short (shaved) hair.
. Subject who will not be available for follow up visits.
. Subject has been treated with a systemic antibiotic within the previous two weeks before screening.