A Clinical Trial to Evaluate Efficacy and Safety of a New Suffocating Head Lice Product.

Inclusion criteria

• ✓. Gender: male / female.
• ✓. Women of childbearing potential is a premenopausal female that is anatomically and physiologically capable of becoming pregnant following menarche.
• ✓or are women of non-childbearing potential, defined as: women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or women who are ≥60 years of age.
• ✓. Age: ≥ 12 months of age year of age at the time of enrollment.
• ✓. Subject must have an active head lice infestation defined as at least 5 live lice (adults and/or nymphs) and 5 apparently live nits, present on the scalp and/or hair, as determined by a trained evaluator.
• ✓. Subject is in good general health based on medical history.
• ✓. The subject or his/her parent/legal guardian (from age 12-17), must give written informed consent, after having been oral and written informed about 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 ages 6-11 years of age will be administered a child's assent form. Subject or his/her parent/legal guardian must be capable of understanding and providing written informed consent.
• ✓. Following application and rinsing of the test products, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24-hour post treatment evaluation has been completed.