Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lic… (NCT07391059) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
Mauritius180 participantsStarted 2026-02
Plain-language summary
Pediculosis capitis or head lice infestation is a human medical condition caused by the infestation of the hair by the parasitic insect Pediculus humanus capitis (human head lice). The most common symptom of infestation is pruritus (itching) on the head which normally intensifies 3 to 4 weeks after the initial infestation.
The test item has been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimate convenience in use - making treatment of head lice infestation easy, and effective in few minutes.
The objectives of this clinical study are to assess the efficacy and the safety of a new Medical Device shampoo for lice infestation treatment compared to a comparator device, already in market.
Who can participate
Age range
2 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:
* Healthy participant,
* Female or male participants,
* Aged 2 years and above (for participants in arms 1 and 2),
* Aged 3 years and above (for participants in arms 3) ,
* Participants with a slight to moderate lice infestation (According to EU norms: 0, 1, 2)
* Participants with various hair types (from 1 to 3C in the hair scale below) and hair length (from short to mid length hair not exceeding shoulder).
* Written informed consent for participants ≥18 years or legal guardian for participants \<18 years given freely and expressly before start of the clinical investigation.
* Participant/Participant's legal guardian is psychologically able to understand the clinical investigation related information and to give written informed consent.
* Participant/participant's legal guardian agreeing to follow the study requirements during the whole clinical investigation period.
* Females of childbearing potential and sexually active should use a contraceptive regimen recognized as effective at least 4 weeks before the beginning of the clinical investigation and during the entire clinical investigation.
* Female participants of childbearing potential, presenting with negative pregnancy test at inclusion.
Exclusion Criteria:
* Pregnant or nursing woman or planning a pregnancy during the clinical investigation;
* Participant who had been deprived of their freedom by an administrative or legal decision or major participant who is under guardianship;
* Participant in…
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.