An interventional study of Elimax Green Lotion with Emogreen and Walgreens Lice Killing Shampoo in Head Lice, sponsored by Oystershell NV. Recruiting at 1 site in United States. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by Oystershell NV · Not applicable, Interventional, and Treatment
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.
Oystershell NV is the lead sponsor of 18 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lice treatment with Elimax Green Lotion (Emogreen)
Device: Elimax Green Lotion with Emogreen
Topical lice treatment with Walgreens Lice Killing Shampoo
Drug: Walgreens Lice Killing Shampoo
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.
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.
Cure rate
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.
Time frame: From enrolment to the end of treatment on day 10
Efficacy for mild and moderate baseline infestations
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).
Time frame: From enrolment to the end of treatment on day 10
Efficacy of the investigational product for all baseline infestations
Determine efficacy of the investigational product for all baseline infestations (cure rate at day 1).
Time frame: From enrolment to the end of treatment on day 1
Efficacy of the investigational product for mild and moderate baseline infestations.
Determine efficacy of the investigational product for mild and moderate baseline infestations (cure rate at day 1).
Time frame: From enrolment to the end of treatment on day 1
Local tolerability
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).
Time frame: From enrolment to the end of treatment on day 10
Global tolerability
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.
Time frame: From enrolment to the end of treatment on day 10
Skin irritation
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
Time frame: From enrolment to the end of treatment on day 10
Eye irritation
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.
Time frame: From enrolment to the end of treatment on day 10
Adverse events
To evaluate characterization of safety and tolerability of the investigational product considering adverse events in the study population.
Time frame: From enrolment to the end of treatment on day 10
Esthetical properties
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
Time frame: The questioning will be performed on day 0 and day 7 after treatment and drying the hair.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2025; primary completion for Mar 2026, 4 months later.
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Oystershell NV