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Head Lice Treatment Comparison: Elimax Green Lotion vs Walgreens Lice Shampoo

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What is being tested

Elimax Green Lotion with Emogreen

+ Walgreens Lice Killing Shampoo
Device
Drug
Who is being recruted

Over 6 Months
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorOystershell NV
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 2, 2025Actual date on which the first participant was enrolled.

This study is focused on comparing two treatments for head lice infestations: Elimax Green Lotion with Emogreen and the Walgreens Lice Killing Shampoo. Head lice are a common problem that affects people of all ages, especially children. The study aims to determine which product is more effective and safer for treating head lice. The Elimax Green Lotion works by physically suffocating and dehydrating the lice and their eggs through its ingredients, which include a bio-alkane and beeswax. This research is important because it could provide a more effective solution for those suffering from head lice, improving comfort and reducing the time spent treating infestations. Participants in this study must be six months old or older and have a confirmed case of head lice. The study will follow guidelines for medical device clinical trials as per US regulations. Participants will use the product according to instructions, typically involving applying the treatment and using a lice comb. Researchers will monitor safety by checking for any skin or eye irritation and other adverse events. The goal is to ensure that the product not only works effectively but is also safe for users. By comparing the results of these two treatments, the study seeks to offer better guidance for people dealing with head lice.

Official TitleIn 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. 
NCT07191457
Principal SponsorOystershell NV
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
86 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 6 MonthsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

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.


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Lice treatment with Elimax Green Lotion (Emogreen)

STEP 1: Apply the lotion to dry hair, completely saturating hair and scalp. Use a towel to cover eyes and exposed skin areas. Massage from the roots to the tips, paying particular attention to the area behind the ears and the hairline at the back of the head. Leave the lotion in the hair for 10 minutes (no longer). In the case of long hair, pin the hair up away from the skin after application. STEP 2: Wash out by applying shampoo to the hair and rinsing thoroughly. Repeat if needed to fully rinse out the lotion. STEP 3: Comb to remove lice and nits. Part the hair into sections and comb one section at a time. Place the teeth of the comb as close as possible to the scalp and comb away from the scalp to the end of the hair. Use clips to pin back each section of combed hair. Clean the comb during use by wiping onto a tissue. Discard the tissue into a sealable bag. Discard the sealed bag. Check hair for the following 7 to 10 days. If lice or nits are present, repeat steps 1-3.
Group II
Active Comparator
Topical lice treatment with Walgreens Lice Killing Shampoo

Apply thoroughly to dry hair or other affected area. For head lice, first apply behind ears and to back of neck Allow product to remain for 10 minutes, but no longer Use warm water to form a lather, shampoo, then thoroughly rinse For head lice, towel dry hair and comb out tangles Remove lice and their eggs (nits) Use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove) Hair should remain slightly damp while removing nits If hair dries during combing, dampen slightly with water For head lice, part hair into sections. Do one section at a time starting at the top of the head. Longer hair may take 1 to 2 hours. Lift a 1- to 2- inch wide strand of the hair. Place comb as close as possible to the scalp and comb with a firm, even motion away from the scalp. Pin back each strand of the hair after combing Clean comb often. Wipe away nits with tissue and discard in a plastic bag. Seal bag and discard bag to prevent lice from coming back.
Study Objectives
Primary Objectives

Demonstrate that local application of Elimax Green Lotion with Emogreen achieves a cure rate that is non-inferior to Wallgreens Lice Killings Shampoo, at the end of day 10, corrected for re-infestation. A non-inferiority margin of 3% will be applied. If non-inferiority is established, a subsequent test will be conducted to assess whether the test product is superior to the reference product. This implies that the lower bound of the confidence interval for the difference in cure rates lies above zero.
Secondary Objectives

Determine efficacy of the investigational product for head lice for mild and moderate baseline infestations (cure rate at the end of the study day 10, uncorrected as well as corrected for re-infestation).

Determine efficacy of the investigational product for all baseline infestations (cure rate at day 1).

Determine efficacy of the investigational product for mild and moderate baseline infestations (cure rate at day 1).

To evaluate local tolerability by subject: subjective symptoms (burning, paraesthesia, pruritus): 0h, 1h, 24h, 7d and 10d p.a. (descriptive evaluation). The following 4-category scale will be used: * Score 1 - None: No sensation reported. * Score 2 - Mild: Slight, brief sensation (e.g. tingling or slight itch) easily tolerated and does not interfere with daily activities. * Score 3 - Moderate: Apparent discomfort (e.g. burning sensation, moderate itching) that may periodically distract or cause a minor disruption but does not require any treatment. * Score 4 - Severe: Prolonged or intense sensation (e.g. strong burning and/or itching) that interferes with normal activities or requires an intervention (e.g. cold compress, medication).

Global tolerability (general well-being and global tolerability of the test product) will be assessed by the blinded study staff at day 10. The global tolerability will be rated on a 4-category scale with: Score 1 = very good, Score 2 = good, Score 3 = moderate, Score 4 = poor. Evaluation at 10d after application.

To evaluate skin irritation by study staff (secondary infection, erythema, excoriation) on day 0, 1, 7 and 10. The following 4-category scale will be used: * Score 1 - None: No visible skin reaction. * Score 2 - Mild: Slight redness or dryness; with no swelling, peeling, or open sores; does not interfere with daily activities. * Score 3 - Moderate: Pronounced erythema, itching, or localized excoriation; may be associated with discomfort or require a non-prescription topical treatment. * Score 4 - Severe: Intense noticeable redness, edema, raw and/or broken skin (e.g. breakdown of skin with oozing or bleeding); may require medical intervention or lead to the discontinuation of the investigational product

To evaluate eye irritation by study staff on day 0, 1, 7 and 10. The following 4-category scale will be used: * Score 1 - None: No redness or irritation; the eyes appear normal. * Score 2 - Mild: Slight conjunctival redness or dryness; with no tearing or discomfort. * Score 3 - Moderate: Noticeable redness with possible tearing or discomfort; does not impair vision or require any treatment. * Score 4 - Severe: Apparent redness with significant irritation, tearing, or pain; possibly interferes with vision or requires medical treatment.

To evaluate characterization of safety and tolerability of the investigational product considering adverse events in the study population.

The esthetical properties of the investigational products will be evaluated to determine the satisfaction by the subjects with the products after application using a questionnaire about hair and scalp feeling, greasiness, hair look, shininess, and volume. With each question being scored on a scale from 1-4: * Score 1 = Strongly agree * Score 2 = Agree * Score 3 = Disagree * Score 4 = Strongly disagree

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
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LSRN ResearchEnid, United StatesSee the location

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One Study Center