Lice; Head LiceNCT07660354
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
A study testing Medical Device (X92001483) in people with Lice; Head Lice, run by Oystershell NV at 1 site in United States.
Trial summary
To compare the safety, effectiveness, and preventive benefits of a medical device (X92001483) against Nix Cream Rinse (1% Permethrin) in people with head lice Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Lice; Head Lice
- What is being tested?
- Medical Device (X92001483)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gender: male / female.
- 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.
- Age ≥ 1 year of age at the time of enrollment.
- 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).
- 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.
- The subject is in good general health based on medical history.
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- 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.
- 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.
- Have a single place of residence or agree to remain at the current residence for the duration of the study.
- 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.
Who cannot join
- 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).
- 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 investigational or comparator 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 investigational product.
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- 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 organization involved in the study.
- People with dreadlocks or clips in hair that cannot be removed or a person who does not want to remove these.
- Hair that is too difficult to work with as assessed by the study staff.
- Families excluded where lice exist however a family member decline 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 male subject per household may be excluded from evaluation if determined to be lice free by self-report or caregiver observation.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
LSRN
Maitland, Florida, 32751
About this study
Official title: 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
Read the 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.
- Conditions
- Lice; Head Lice
- Being tested
- Medical Device (X92001483)
- Keywords
- Head Lice Treatment
- Medical subject headings
- Lice Infestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device (X92001483)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Medical Device X92001483 | Experimental | 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. Receives: Device: Medical Device (X92001483) |
| Nix Cream Rinse (1% Permethrin) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Preventative Effect
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.
Measured: 14 days
Maintenance of cure rate over time
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.
Measured: day 3, day 7, day 10, day 13 and day 14
Secondary outcomes (5)
Time to re-infestation
Characterize the time to re-infestation in each treatment group
Measured: 14 days
Number of live lice
To compare the number of live lice detected at each assessment across treatment groups.
Measured: Day 0, day 3, day 7, day 10, days 13, day 14
Local tolerability
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.
Measured: day 0, day 3, day 7, day 10, day 13 and day 14
Scalp and skin irritation
To evaluate scalp and skin irritation by study staff (secondary infection, erythema, excoriation) following product application.
Measured: day 0, day 3, day 4, day 7, day 10, day 13 and day 14
Adverse advents
To record and characterize all treatment-emergent adverse events occurring during the study.
Measured: Day 0, day 3, day 7, day 10, day 13 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 May 2026
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lice; Head LiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Two-Arm, Randomized, Controlled, Investigator/Assessor-Blinded, Comparative Study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LSRN Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660354
- Sponsor's protocol ID
- OYS012-0025
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07660354
- Acronym / sponsor ID
- OYS012-0025
- Conditions
- Lice; Head Lice
- Keywords
- Head Lice Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Collaborators
- LSRN Research
- Study start
- 1 May 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety, effectiveness, and preventive benefits of a medical device (X92001483) against Nix Cream Rinse (1% Permethrin) in people with head lice
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Two-Arm, Randomized, Controlled, Investigator/Assessor-Blinded, Comparative Study
| Arm | Type | Receives |
|---|---|---|
| Medical Device X92001483 | Experimental | Device: 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. |
| Nix Cream Rinse (1% Permethrin) | No intervention | –Treatment of subjects with Head Lice with Nix Cream Rinse (1% Permethrin) with a physical mode of action on day 0 and day 7. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Gender: male / female.
- 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.
- Age ≥ 1 year of age at the time of enrollment.
- 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).
- 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.
Key exclusion criteria (20 listed)
- 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).
- 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 investigational or comparator products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Medical Device X92001483 |
Primary outcome
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.
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.
5 secondary outcomes
Time to re-infestation
Time frame: 14 days
Number of live lice
Time frame: 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
Scalp and skin irritation
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Device (X92001483) in people with Lice; Head Lice, run by Oystershell NV at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Shepherd (561-635-2884, katie@licesolutions.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preventative Effect (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.