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

In Vivo Testing: A Two-Arm, Randomized, Controlled, Investigator/Assessor-Blinded, Comparative Study to Evaluate the Safety and Efficacy of a Head Lice Physically Acting Product: ELIMAX GREEN LOTION EMOGREEN (X92001752) vs Walgreens Lice Killing Shampoo (Piperonyl Butoxide (4%),Pyrethrum Extract (Equivalent to 0.33% Pyrethrins)) in Subjects With Head Lice.

Compare efficacy and safety of Elimax Green Lotion Emogreen (RID SUper Max Solution) to that of Walgreens Lice Killing Shampoo against headlice in infested individuals. Involved subjects aged 6 months and older, of both genders, with a confirmed diagnosis of head lice infestation are included. Local and global tolerability, skin and eye irritation are monitored throughout the study. Any adverse events will be monitored and recorded.

The primary objective of this study is to evaluate and compare efficacy and safety of X92001752 Emogreen with Walgreens Lice Killing Shampoo (Piperonyl Butoxide (4%), Pyrethrum Extract (Equivalent to 0.33% Pyrethrins)) against head lice (Pediculus capitis) in infested individuals. More specifically, the present study aims to confirm the clinical performance and safety of head lice treatment product: Elimax Green Lotion with Emogreen L15® (INCI C15-19 alkane) as main ingredient (X92001752). This product works in the same way as Elimax Green Lotion with Hemisqualane® (INCI hydrogenated farnesene) namely, by physically suffocating and dehydrating lice and their nits due to the presence of a bio-alkane and beeswax. They are generally combined with a lice comb in a procedure pack. Elimax Green Lotion is classified as Class I medical devices in Europe. In the US, the products are packaged with a lice comb and registered as a Lice Removal Kit, in accordance with 21 CFR 880.5960, which is 510(k)-exempt.

In line with US regulations, the guidelines for clinical trials of medical devices must be adhered to. The study will involve subjects aged 6 months and older, of both genders, with a confirmed diagnosis of head lice infestation. To support safety assessments, local and global tolerability, skin and ocular irritation, and adverse events (AEs) will be monitored and recorded.

Inclusion Criteria:

• Gender: male / female.
• Female subjects with childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control (as described in section7.8) or remain
• 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 on the 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's baby shampoo (See figure 4 for shampoo image) to rinse out the product according to the study product its IFU. 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.
• Agree to not use any other anti-lice treatment or medicated hair grooming products for the duration of the study (through Day 10 visit).
• The parent or legal guardian of a child must be willing to have other family members screened for head lice. If other household members are found to have head lice and are eligible, they must be either enrolled in the study OR receive the standard of care 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 the duration of the study.
• 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. Subject or his/her parent/legal guardian must be capable of understanding and providing written informed consent.

Exclusion Criteria:

• Application of any form of head lice treatment, whether prescription or over-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 period of 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 study results.
• Known skin allergies, multiple drug allergies or multiple allergies to cosmetic products.
• History of allergy or hypersensitivity to active ingredients, or constituents of the test products.
• Subject with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test product.
• Subjects with chronic scalp disorder.
• Subject or his/her legal guardian who, in the opinion of the investigative personnel, do not understand the subject requirements for study participations and/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 investigational trial within the preceding 14 days.
• The subject is directly affiliated to the investigator site personnel and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
• The subject is an Oystershell employee or is an employee of a third-party organizations 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 does not 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 the study.
• Subjects who are receiving, or are expected to receive, any antibiotic therapy during the study period will be excluded.
• No more than one working subject per household may be excluded from evaluation if he is assessed as being lice by himself or caregiver. Only working male can be excluded from evaluation if individual is bald or hair no longer than half inch and deemed lice free by himself or another adult.
• All household members of the subject, other than excluded male adult, must be screened for head lice by a licenced head lice professional. If additional household members are found to have head lice and meet the study criteria, they will be referred to LSRN Research and enrolled in study. If a household member declines enrollment, all family members will be excluded from the study.