CompletedNot Applicable

Treatment of Head Lice Infestation Using Novel Ultrasonic Comb

Israel23 participantsStarted 2016-11-28

Plain-language summary

A pilot study to evaluate safety and efficacy of the Lucy combined with LucyGel in killing head lice and their eggs. 23 participants will be enrolled in this study. The first 12 will be combed with model A and the remaining 11 will be combed with model B

Who can participate

Age range

6 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: * Males and Females * Age 6 years and older at the time of enrollment * Must have an active head lice infestation of at least 10live head lice (found within 5 minutes of mechanic search). * Hair must be at least 3 cm long. * Written informed consent - by patient (if over 18 years of age), or by a parent (if patient is under 18 years of age). * For females of childbearing potential, a statement declaring that she is not currently pregnant. Exclusion Criteria: * Used any chemical head lice treatment in the 7 days preceding the trial treatment * Used antibiotics in the week preceding treatment * Open wounds in the treatment area * Skin irritation in the treatment area * Individuals with skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with treatment or evaluation * Known allergies to any of the gel's components * Participant that is already enrolled in another study * Participant who can't be combed with fine Comb dense ASSY2000

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

Adverse events of the device and treatment

Timeframe: up to three days

Trial details

NCT IDNCT02854878

SponsorParaSonic Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07-26

View on ClinicalTrials.gov More Pediculus Capitis trials

Who can participate

Age range

6 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.