In Vivo Testing : A Two-Arm, Randomized, Controlled, Investigator/Assessor-Blinded, Comparative Study to Evaluate the Safety, Efficacy, and Preventative Effect of a Head Lice Physically Acting Product: 2 in 1 SHAMPOO EU VERSION (X92001483) vs NIX CREME RINSE (1% Permethrin) in Subjects With Head Lice.
To compare the safety, effectiveness, and preventive benefits of a medical device (X92001483) against Nix Cream Rinse (1% Permethrin) in people with head lice
• Gender: male / female.
• The subject or his/her parent/legal guardian (from age 12-17) must give written informed consent (after having been informed orally and by written text about the benefits and potential risks of the trial, as well as information regarding the insurance, taken out to cover the subjects participating in the study). A caregiver must sign an informed consent agreement for children not old enough to do so. Children aged 6-11 years of age will be administered a child's assent form. The subject or his/her parent/legal guardian must be capable of understanding and providing written informed consent.
• Age ≥ 1 year of age at the time of enrollment.
• Subject agree to not use any other anti-lice or preventative treatment or medicated hair grooming products for the duration of the study (through last visit day- Day 14).
• Subject must have an active head lice infestation defined as at least 5 live lice (adults and/or nymphs) and 5 live nits based on magnified observations, present on the scalp and/or hair, as determined by a trained evaluator.
• The subject is in good general health based on medical history.
• Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a reliable method of birth control (as described in section 7.8) during duration of the study.
• The parent or legal guardian of a child subject must consent to the screening of other household members for head lice. If additional household members are found to have head lice and meet eligibility criteria, they must be enrolled in the study for all household members to qualify for participation.
• Have a single place of residence or agree to remain at the current residence for the duration of the study.
⁃ Subject agrees not to additionally shampoo, wash, or rinse their hair or scalp for 24-hours post treatment.
⁃ The subject agrees not to cut or chemically treat their hair while participating in the study.
⁃ Subject agrees to follow all study instructions, including attending all follow-up appointments.