Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo

Inclusion Criteria:

• Gender: male / female.

• Female subjects with childbearing potential who test negative for pregnancy andagree to use a reliable method of birth control (as described in section7.8) orremain

• Age ≥ 6 months 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 live nits based on magnified observations, present onthe scalp and/or hair, as determined by a trained evaluator.

• Subject is in good general health based on medical history.

• Following application per designated product timeline shampoo hair using Johnson'sbaby shampoo (See figure 4 for shampoo image) to rinse out the product according tothe study product its IFU. Subject agrees not to additionally shampoo, wash, orrinse their hair or scalp for 24-hours post treatment.

• The subject agrees not to cut or chemically treat their hair while participating inthe study.

• Subject agrees to follow all study instructions, including attending all follow-upappointments.

• Agree to not use any other anti-lice treatment or medicated hair grooming productsfor the duration of the study (through Day 10 visit).

• 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 andare eligible, they must be either enrolled in the study OR receive the standard ofcare at the site and in the same manner as study participants.

• Have a single place of residence or agree to remain at the current residence for theduration of the study.

• The subject or his/her parent/legal guardian (from age 12-17), must give writteninformed consent, after having been informed orally and by written text about thebenefits and potential risks of the trial, as well as information regarding theinsurance, taken out to cover the subjects participating in the study. A caregivermust 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. Subjector his/her parent/legal guardian must be capable of understanding and providingwritten informed consent.

Exclusion Criteria:

• Application of any form of head lice treatment, whether prescription orover-thecounter (OTC), or home remedy for 14 days prior to their screening visit (Visit

• Application of any topical medication of any kind on the hair or scalp for a periodof 48 hours prior to the screening visit.

• Use of systemic or topical drugs or medications, including systemic antibiotics,which in the opinion of the investigative personnel may interfere with the studyresults.

• Known skin allergies, multiple drug allergies or multiple allergies to cosmeticproducts.

• History of allergy or hypersensitivity to active ingredients, or constituents of thetest products.

• Subject with any visible skin/scalp condition at the treatment site which, in theopinion of the investigative personnel, will interfere with the evaluation of thetest product.

• Subjects with chronic scalp disorder.

• Subject or his/her legal guardian who, in the opinion of the investigativepersonnel, do not understand the subject requirements for study participationsand/or may be likely to exhibit poor compliance with the required visits.

• Females who are pregnant or nursing.

• Hair longer than waist length.

• Subject suspected or known not to follow instructions

• Previous participation in this study or participation in any other investigationaltrial within the preceding 14 days.

• The subject is directly affiliated to the investigator site personnel and/or theirimmediate families. Immediate family is defined as a spouse, parent, child, orsibling, whether biological or legally adopted.

• The subject is an Oystershell employee or is an employee of a third-partyorganizations involved in the study.

• Exclude families with 4 or more household members.

• People with dreadlocks or clip in hair that cannot be removed or a person who doesnot want to remove these.

• Hair that is too difficult to work with, assessed by the study staff.

• Families excluded where lice exist however family member declines enrollment in thestudy.

• Subjects who are receiving, or are expected to receive, any antibiotic therapyduring the study period will be excluded.

• No more than one working subject per household may be excluded from evaluation if heis assessed as being lice by himself or caregiver. Only working male can be excludedfrom evaluation if individual is bald or hair no longer than half inch and deemedlice free by himself or another adult.

• All household members of the subject, other than excluded male adult, must bescreened for head lice by a licenced head lice professional. If additional householdmembers are found to have head lice and meet the study criteria, they will bereferred to LSRN Research and enrolled in study. If a household member declinesenrollment, all family members will be excluded from the study.