Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07391059
Eligibility Criteria:
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 a social or sanitary establishment;
* Participant being in an exclusion period from a previous clinical investigation or who is currently participating to another clinical investigation on hair/scalp or who participated to another clinical clinical investigation on hair/scalp within 3 months before first visit.
* Participant suspected to be non-compliant according to the Investigator's judgment.
* Participant allergic to any of the ingredients and/or materials of the intended to be used products (investigation device and anti-lice comb, comparative device, post-treatment shampoo).
Participant with curly hair (from 4A to 4C in the hair type scale).
* Participant with hair length exceeding shoulder.
* Participants with more than 24 lice on the head.
* Participant suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the clinical investigation results.
* Participant with a cutaneous disease on the studied zone (scalp and hair).
* Severe scratches or open wounds/skin damage on the scalp (lice bites allowed however).
* Participant with a known or suspected allergy to one or more of the components of the investigational or comparator devices.
* Participant who has diabetes.
* Participant with known or suspected immune deficiency or autoimmune disease.
Participant 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 clinical investigation;
* corticosteroids during the 2 previous weeks and during the clinical investigation;
* retinoids and/or immunosuppressors during the 3 previous months and during the clinical investigation ;
* any medication stabilized for less than one month.
* Participant who received an anti-lice treatment in the previous month.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT07391059
Study Brief:
Protocol Section:
NCT07391059