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

Inclusion Criteria:

1. Gender: male / female.
2. Women of childbearing potential is a premenopausal female that is anatomically andphysiologically capable of becoming pregnant following menarche. Female subjects: are women of childbearing potential who test negative for pregnancyand agree to use a reliable method of birth control or remain abstinent during thestudy. Methods of contraception considered acceptable include oral contraceptives,contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptivegel, or condom with contraceptive gel -or are women of non-childbearing potential, defined as: women who have had surgicalsterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or women whoare ≥60 years of age.
3. Age: ≥ 12 months of age year of age at the time of enrollment.
4. 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.
5. Subject is in good general health based on medical history.
6. The subject or his/her parent/legal guardian (from age 12-17), must give writteninformed consent, after having been oral and written informed about benefits andpotential risks of the trial, as well as information regarding the insurance, takenout to cover the subjects participating in the study. A caregiver must sign aninformed consent agreement for children not old enough to do so. Children ages 6-11years of age will be administered a child's assent form. Subject or his/herparent/legal guardian must be capable of understanding and providing written informedconsent.
7. 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 hasbeen completed.
8. The subject agrees not to cut or chemically treat their hair while participating inthe study.
9. No more than one working male per household may be excluded from evaluation if he isassessed as being lice free by himself or caregiver.
10. Subject agrees to follow all study instructions, including attending all follow-upappointments.
11. Agree to not use any other pediculicides or medicated hair grooming products for theduration of the study (through Day 10 visit).
12. The parent or legal guardian of a child must be willing to have other family membersscreened for head lice. If other household members are found to have head lice and areeligible, they must be either enrolled in the study OR receive the standard of care atthe site and in the same manner as study participants.
13. Have a single place of residence.
14. The subject or his/her parent or legal guardian must give written informed consent,after having been oral and written informed about benefits and potential risks of thetrial, as well as details of the insurance taken out to cover the subjectsparticipating in the study.
15. Subjects must agree to not use any other ant-lice treatment for the duration of thestudy.

Exclusion Criteria:

1. Application of any form of head lice treatment, whether prescription or over-the-counter (OTC), or home remedy for 14 days prior to their screening visit (Visit 1). Application of any topical medication of any kind on the hair for a period of 48 hoursprior to the screening visit.
2. Use of systemic or topical drugs or medications, including systemic antibiotics, whichin the opinion of the investigative personnel may interfere with the study results.
3. Known skin allergies, multiple drug allergies or multiple allergies to cosmeticproducts.
4. History of allergy or hypersensitivity to active ingredients, or constituents of thetest products.
5. Subject with any visible skin/scalp condition at the treatment site which, in theopinion of the investigative personnel, will interfere with the evaluation of the testproduct.
6. Subjects with chronic scalp disorder. 8. Subject or his/her legal guardian who, in theopinion of the investigative personnel, do not understand the subject requirements forstudy participations and/or may be likely to exhibit poor compliance with the requiredvisits.
7. Females who are pregnant or nursing. 10. Hair longer than mid-back. 11. Subjectsuspected or known not to follow instructions 12. Previous participation in this study orparticipation in any other investigational trial within the preceding 14 days.
8. The subject is directly affiliated to the investigator site personnel and/or theirimmediate families. Immediate family is defined as a spouse, parent, child, or sibling,whether biological or legally adopted.
9. The subject is an Oystershell employee or is an employee of a third-party organizationsinvolved in the study.