Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).

June 16, 2026 updated by: Oystershell NV

In Vivo Testing : A Two-Arm, Randomized, Controlled, Investigator/Assessor-Blinded, Comparative Study to Evaluate the Safety, Efficacy, and Preventative Effect of a Head Lice Physically Acting Product: 2 in 1 SHAMPOO EU VERSION (X92001483) vs NIX CREME RINSE (1% Permethrin) in Subjects With Head Lice.

To compare the safety, effectiveness, and preventive benefits of a medical device (X92001483) against Nix Cream Rinse (1% Permethrin) in people with head lice

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Compare Safety, Efficacy and preventative effect of a medical device with a physical mode of action against Nix Cream Rinse (1% Permethrin) in Subjects with Head Lice in a two-arm, randomized, controlled, Investigator/Assessor-blinded comparative study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Maitland, Florida, United States, 32751
        • Recruiting
        • LSRN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Gender: male / female.
  2. 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. The subject or his/her parent/legal guardian must be capable of understanding and providing written informed consent.
  3. Age ≥ 1 year of age at the time of enrollment.
  4. Subject agree to not use any other anti-lice or preventative treatment or medicated hair grooming products for the duration of the study (through last visit day- Day 14).
  5. 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.
  6. The subject is in good general health based on medical history.
  7. Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a reliable method of birth control (as described in section 7.8) during duration of the study.
  8. The parent or legal guardian of a child subject must consent to the screening of other household members for head lice. If additional household members are found to have head lice and meet eligibility criteria, they must be enrolled in the study for all household members to qualify for participation.
  9. Have a single place of residence or agree to remain at the current residence for the duration of the study.
  10. Subject agrees not to additionally shampoo, wash, or rinse their hair or scalp for 24-hours post treatment.
  11. The subject agrees not to cut or chemically treat their hair while participating in the study.
  12. Subject agrees to follow all study instructions, including attending all follow-up appointments.

Exclusion Criteria:

  1. Application of any form of head lice treatment, whether prescription or over-the counter (OTC), or home remedy for 14 days prior to their screening visit (Visit 1).
  2. Application of any topical medication of any kind on the hair or scalp for a period of 48 hours prior to the screening visit.
  3. 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.
  4. Known skin allergies, multiple drug allergies or multiple allergies to cosmetic products.
  5. History of allergy or hypersensitivity to active ingredients, or constituents of the investigational or comparator products.
  6. 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 investigational product.
  7. Subjects with chronic scalp disorder.
  8. 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.
  9. Females who are pregnant or nursing.
  10. Hair longer than waist length.
  11. Subject suspected or known not to follow instructions
  12. Previous participation in this study or participation in any other investigational trial within the preceding 14 days.
  13. 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.
  14. The subject is an Oystershell employee or is an employee of a third-party organization involved in the study.
  15. People with dreadlocks or clips in hair that cannot be removed or a person who does not want to remove these.
  16. Hair that is too difficult to work with as assessed by the study staff.
  17. Families excluded where lice exist however a family member decline enrollment in the study.
  18. Subjects who are receiving, or are expected to receive, any antibiotic therapy during the study period will be excluded.
  19. No more than one working male subject per household may be excluded from evaluation if determined to be lice free by self-report or caregiver observation.
  20. All household members of the subject, other than excluded male adult, must be screened for head lice by a certified 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Medical Device X92001483
Treatment of subjects with head Lice with the standard of care product Nix Creme Rinse on day 0 and day 7, followed by intermediate application of the medical device (X92001483) with a physical mode of action applied every 3 days.
Device: Medical Device (X92001483)
Treatment of subjects with Head Lice with a medical device (X92001483) with a physical mode of action on day 0, day 7, day 10, day 13 and day 14.
No Intervention: Nix Cream Rinse (1% Permethrin)
Treatment of subjects with Head Lice with Nix Cream Rinse (1% Permethrin) with a physical mode of action on day 0 and day 7.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Preventative Effect
Time Frame: 14 days
Determin whether subjects treated with the medical device X92001943 after treatment with Nix Creme Rinse maintain a higher cure rate at the end of the study compared with subjects treated only with Nix Creme Rinse.
14 days
Maintenance of cure rate over time
Time Frame: day 3, day 7, day 10, day 13 and day 14
To assess the maintenance of cure over time: To compare cure rates between subjects treated with Nix Creme Rinse and the medical device X92001483 at interim visits in order to evaluate the presence and persistence of the preventive effect of the investigational product relative to standard of care product (Nix creme rinse) alone.
day 3, day 7, day 10, day 13 and day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to re-infestation
Time Frame: 14 days
Characterize the time to re-infestation in each treatment group
14 days
Number of live lice
Time Frame: Day 0, day 3, day 7, day 10, days 13, day 14
To compare the number of live lice detected at each assessment across treatment groups.
Day 0, day 3, day 7, day 10, days 13, day 14
Local tolerability
Time Frame: day 0, day 3, day 7, day 10, day 13 and day 14
To evaluate the local tolerability of the standard of care product and investigational product, as measured by subject reported symptoms (eg: burning, paraesthesia, pruritus) following application.
day 0, day 3, day 7, day 10, day 13 and day 14
Scalp and skin irritation
Time Frame: day 0, day 3, day 4, day 7, day 10, day 13 and day 14
To evaluate scalp and skin irritation by study staff (secondary infection, erythema, excoriation) following product application.
day 0, day 3, day 4, day 7, day 10, day 13 and day 14
Adverse advents
Time Frame: Day 0, day 3, day 7, day 10, day 13 and day 14
To record and characterize all treatment-emergent adverse events occurring during the study.
Day 0, day 3, day 7, day 10, day 13 and day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oystershell NV

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LSRN Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OYS012-0025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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