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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

Head Lice

Over 6 Months
+33 Eligibility Criteria

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: September 24, 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. 
Principal SponsorOystershell NV
Last updated: September 24, 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.
Conditions
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.
Conditions
Pathology
Head Lice
Criteria
12 inclusion criteria required to participate
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

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21 exclusion criteria prevent from participating
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

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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)
Group II
Active Comparator
Topical lice treatment with Walgreens Lice Killing Shampoo
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