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

NCT07191457 | Recruiting

• 1 other identifier: OYS011-0025
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head Lice

Keywords

Head Lice; Walgreens Lice Killing Shampoo; Elimax Green Lotion Emogreen; RID Super Max Solution; Pyrethrum

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrolment to the end of treatment on day 10

Secondary Outcomes (9)

• Efficacy for mild and moderate baseline infestations

  From enrolment to the end of treatment on day 10

• Efficacy of the investigational product for all baseline infestations

  From enrolment to the end of treatment on day 1

• Efficacy of the investigational product for mild and moderate baseline infestations.

  From enrolment to the end of treatment on day 1

• Local tolerability

  From enrolment to the end of treatment on day 10

• Global tolerability

  From enrolment to the end of treatment on day 10

Study Arms (2)

Treatment with Elimax Green Lotion with Emogreen

EXPERIMENTAL

Lice treatment with Elimax Green Lotion (Emogreen)

Device: Elimax Green Lotion with Emogreen

Treatment with Walgreens Lice Killing Shampoo

ACTIVE COMPARATOR

Topical lice treatment with Walgreens Lice Killing Shampoo

Drug: Walgreens Lice Killing Shampoo

Interventions

Elimax Green Lotion with Emogreen DEVICE

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.

Treatment with Elimax Green Lotion with Emogreen

Walgreens Lice Killing Shampoo DRUG

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.

Treatment with Walgreens Lice Killing Shampoo

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oystershell NV: lead
• Lice Solutions Resource Network (LSRN) Research: collaborator

Study Sites (1)

LSRN Research

Enid, Oklahoma, 73701, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Two-Arm, Randomized, Controlled, Investigator/Assessor-Blinded Comparative Study.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 24, 2025
• Study Start: October 2, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)