Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation

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.