Comparative Study for the Evaluation of Two Medical Devices on the Treatment of Head Lice Infestation

Inclusion Criteria:

• Healthy subject;
• Sex: male or female;
• Age: 2 years and above;
• Subject with a slight to moderate lice infestation (according to EU norms);
• Subjects with various hair type (from 1 to 3C - hair scale) and hair length (fromshort to mid length hair, not exceeding shoulder);
• Documented oral informed consent for all subjects, including minors, given freely andexpressly before the start of the study;
• Written informed consent for subjects ≥18 years or legal guardian for subjects < 18years 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 studyrelated information and to give written informed consent;
• Females of childbearing potential must have a negative pregnancy test before thebeginning of the study.

Exclusion Criteria:

• Pregnant (confirmed by pregnancy test for women of childbearing potential) or nursingwoman or planning a pregnancy during the study;
• Subject who had been deprived of their freedom by administrative or legal decision oradult subject who is under guardianship;
• Subject in a social or sanitary establishment;
• Subject in an exclusion period from a previous study or who is currently participatingin another study on hair/scalp or who participated to another clinical study onhair/scalp within 3 months before first visit;
• Subject suspected to be non-compliant according to the investigator's judgment;
• Subject with curly or frizzy hair (from 4A to 4C in the hair type scale);
• Subject with hair length below the shoulder;
• Subjects with more than 24 lice on the head. In terms of associated pathology
• Subject suffering from a severe or progressive disease or any other pathology that mayinterfere with the evaluation of the study results;
• Subject with a cutaneous disease on the studied zone (scalp and hair);
• Subject with severe scratches or open wounds/skin damages on the scalp (lice bitesallowed however);
• Subject with a known or suspected allergy to any of the components/materials of theinvestigational devices, anti-lice comb or post-treatment shampoo;
• Subject who has diabetes (type 1 or 2);
• Subject with known or suspected immune deficiency or autoimmune disease. Relating to previous or ongoing treatment
• 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 weeksand during the study;
• corticosteroids during the 2 previous weeks and during the study;
• retinoids and/or immunosuppressors during the 3 previous months and during thestudy;
• any medication stabilized for less than one month.
• Subject who received an anti-lice treatment in the previous 2 months.