New Lice-Zapping device takes on shampoo in Head-to-Head trial
NCT ID NCT07244523
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a new medical device that works physically (X92001919) to a standard anti-lice shampoo (Paranix) for treating head lice. About 34 healthy people aged 2 and older with mild to moderate lice will receive either the device or the shampoo. The main goal is to see which treatment clears lice more effectively by day 10.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy subject (except head lice infestation) based on medical history; * Gender: male or female; * Age: 2 years and above at the time of enrolment ; * Subject with a slight to moderate lice infestation (according to EU norms) * Subjects with various hair type (from 1 to 3C in the hair scale below) and hair length (from short to mid length hair, not exceeding shoulder) * Documented oral informed consent for all subjects, including minors, given freely and expressly before the start of the study * Written informed consent for subjects ≥18 years or legal guardian for subjects \< 18 years given freely and expressly before start of the study; * Written assent for subjects ≥12 to \<18 years. * Subject/Subject's legal guardian is psychologically able to understand the study related information and to give written informed consent; * Females of childbearing potential must have a negative pregnancy test before the beginning of the study and agree to use a reliable method of birth control during the study. * Subject agrees not to cut or chemically treat their hair while participating in the study. * Subjects agrees not to use any other anti-lice treatment or medicated hair grooming products for the duration of the study. Exclusion Criteria: * In terms of population 1. Pregnant (confirmed by pregnancy test at D0 for women of childbearing potential) or nursing woman or planning a pregnancy during the study; 2. Subject who had been deprived of their freedom by administrative or legal decision or adult subject who is under guardianship; 3. Subject in a social or sanitary establishment; 4. Subject in an exclusion period from a previous study or who is currently participating in another study on hair/scalp or who participated to another clinical study on hair/scalp within 3 months before first visit. 5. Subject suspected to be non-compliant according to the Investigator's judgment. 6. Subject with curly or frizzy hair (from 4A to 4C in the hair type scale above). 7. Subject with hair length below the shoulder. 8. Subjects with more than 24 lice on the head. * In terms of associated pathology 9. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results. 10\. Subject with a cutaneous disease on the studied zone (scalp and hair). 11. Subject with severe scratches or open wounds/skin damages on the scalp (lice bites allowed however). 12\. Subject with a known or suspected allergy to any of the components/materials of the investigational products, anti-lice comb or post- treatment shampoo. 13\. Subject who has diabetes (type 1 or 2). 14. Subject with known or suspected immune deficiency or autoimmune disease. * Relating to previous or ongoing treatment 15. Subject undergoing a topical treatment on the test area or a systemic treatment with: * anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study; * corticosteroids during the 2 previous weeks and during the study; * retinoids and/or immunosuppressors during the 3 previous months and during the study; * any medication stabilized for less than one month. 16. Subject who received an anti-lice treatment in the previous 2 months.
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Conditions
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As listed by the trial registrant
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