Lice; Head LiceNCT07244523
Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
A study testing Pulverize (X92001919) in people with Lice; Head Lice, run by Oystershell NV.
Trial summary
Comparison of the efficacy of a new medical device with a physical mode of action to Paranix anti-lice shampoo in the treatment of head lice infestation. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Lice; Head Lice
- What is being tested?
- Pulverize (X92001919)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Apr 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy subject (except head lice infestation) based on medical history;
- Gender: male or female;
- Age: 2 years and above at the time of enrolment ;
- Subject with a slight to moderate lice infestation (according to EU norms)
- Subjects with various hair type (from 1 to 3C in the hair scale below) and hair length (from short to mid length hair, not exceeding shoulder)
- Documented oral informed consent for all subjects, including minors, given freely and expressly before the start of the study
Show all 12Show fewer
- Written informed consent for subjects ≥18 years or legal guardian for subjects < 18 years given freely and expressly before start of the study;
- Written assent for subjects ≥12 to <18 years.
- Subject/Subject's legal guardian is psychologically able to understand the study related information and to give written informed consent;
- Females of childbearing potential must have a negative pregnancy test before the beginning of the study and agree to use a reliable method of birth control during the study.
- Subject agrees not to cut or chemically treat their hair while participating in the study.
- Subjects agrees not to use any other anti-lice treatment or medicated hair grooming products for the duration of the study.
Who cannot join
- In terms of population
- Pregnant (confirmed by pregnancy test at D0 for women of childbearing potential) or nursing woman or planning a pregnancy during the study;
- Subject who had been deprived of their freedom by administrative or legal decision or adult subject who is under guardianship;
- Subject in a social or sanitary establishment;
- Subject in an exclusion period from a previous study or who is currently participating in another study on hair/scalp or who participated to another clinical study on hair/scalp within 3 months before first visit.
- Subject suspected to be non-compliant according to the Investigator's judgment.
Show all 18Show fewer
- Subject with curly or frizzy hair (from 4A to 4C in the hair type scale above).
- Subject with hair length below the shoulder.
- Subjects with more than 24 lice on the head.
- In terms of associated pathology 9. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
- 10. Subject with a cutaneous disease on the studied zone (scalp and hair). 11. Subject with severe scratches or open wounds/skin damages on the scalp (lice bites allowed however).
- 12. Subject with a known or suspected allergy to any of the components/materials of the investigational products, anti-lice comb or post- treatment shampoo.
- 13. Subject who has diabetes (type 1 or 2). 14. Subject with known or suspected immune deficiency or autoimmune disease.
- Relating to previous or ongoing treatment 15. Subject undergoing a topical treatment on the test area or a systemic treatment with:
- anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study;
- corticosteroids during the 2 previous weeks and during the study;
- retinoids and/or immunosuppressors during the 3 previous months and during the study;
- any medication stabilized for less than one month. 16. Subject who received an anti-lice treatment in the previous 2 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Comparative, Two-arms, Randomized, Controlled, Investigator/Assessor-blinded Study for the Evaluation of the Efficacy and Safety of a Medical Device With a Physical Mode of Action (X92001919) Versus Paranic Anti-lice Shampoo on the Treatment of Head Lice Infestation.
Comparison of the efficacy of a new medical device with a physical mode of action to Paranix anti-lice shampoo in the treatment of head lice infestation.
Read the detailed description
Pediculosis capitis or head lice infestation is a human medical condition caused by the infestation of the hair by the parasitic insect Pediculus humanus capitis (human head lice). When lice feed, they inject saliva into the scalp. The saliva is an anticoagulant which keeps blood from clotting making their feeding process easier. Many individuals experience an allergic reaction to the saliva, causing up to 50% of the population with head lice to itch. For this reason, the most common symptom of infestation is pruritus (itching) on the head. The bite reaction is very mild and it can be rarely seen between the hairs. In rare cases, the itch scratch cycle can lead to secondary infection. Swelling of the local lymph nodes and fever are rare.
There are a range of interventions available for the management of head lice. The main stay of therapy has been largely dependent on insecticidal-based approaches for several decades. However, the accumulating evidence with resistance to frontline insecticidal treatments like pyrethrins, permethrin and malathion has led to a growing incentive to develop newer and more effective treatments to treat the condition safely [3]. Over the past couple of decades, alternative candidates have been introduced into the market, including products with a physical mode of action that works via dehydration and suffocation of the lice [4-8].
The tested product has been developed with the ambition to offer a complete and safe head lice treatment, highly effective against head lice and eggs, whilst also offering ultimate convenience in use - making treatment of head lice infestation easy, and effective in few minutes. This is a medical device, not yet on the market, with a physical mode of action of suffocation and dehydration. The comparator product, Paranix® Anti-Lice Shampoo, is a reference product with a physical mode of action, available on the market in Europe as a class I medical device.
The main objective of the current study is to evaluate the efficacy and safety on head lice treatment of the device X92001919 versus Paranix® Anti-Lice Shampoo comparator.
- Conditions
- Lice; Head Lice
- Being tested
- Pulverize (X92001919), Paranix Anti-Lice Shampoo
- Medical subject headings
- Lice Infestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulverize (X92001919)Device
Treatment at Day 0, Day 3 and Day 7 with the Pulverize Dry Shampoo formulation (X92001919)
Paranix Anti-Lice ShampooDevice
Treatment at Day 0 and Day 7 with the Paranix Anti-Lice Shampoo
| Study group | Role | What they receive |
|---|---|---|
| Pulverize (X92001919) | Experimental | Treatment with product Pulverize at Visit 1 (Day 0),Visit 2 (Day 3) and Visit 3 (Day 7). Counting alive lice and nymphs in the hair at Visit 1 (Day 0), Visit 2 (Day 3), Visit 3 (Day 7) and Visit 4 (Day 10). Receives: Device: Pulverize (X92001919) |
| Paranix Anti-Lice Shampoo | Active comparator | Treatment with product Paranix Anti-Lice Shampoo at Visit 1 (Day 0) and Visit 3 (Day 7). Counting alive lice and nymphs in the hair at Visit 1 (Day 0), Visit 2 (Day 3), Visit 3 (Day 7) and Visit 4 (Day 10). Receives: Device: Paranix Anti-Lice Shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Pulverize (X92001919) compared to the comparator Paranix Anti-Lice Shampo.
Evaluate the efficacy of Pulverize (X92001919) compared to the comparator Paranix Anti-Lice Shampoo on the treatment of head lice infestation, after one treatment consisting of 3 applications. Efficacy of the treatment will be defined as the cure rate at the end of day 10, corrected for re-infestation.
Measured: 10 days
Secondary outcomes (7)
Efficacy comparison (uncorrected for re-infestation)
Evaluate and compare the efficacy for both products. (cure rate at the end of day 10, uncorrected for re-infestation).
Measured: 10 days
Cure rate on day 3 and day 7
Evaluation of the cure rate on day 3 and day 7 in both separate groups, and comparison of both product effect after only one (on day 3) or two applications (day 7 for Pulverize versus day 10 for Paranix).
Measured: day 3 for cure rate of first application day 7/day 10 for second application (depending on treatment).
Indirect efficacy on eggs and evaluate potential re-infestation
Presence of live lice and nymphs, for both groups and between groups, without combing on hair and close to scalp on day 0 (prior to treatment to assess severity of the infestation), day 3, day 7, and day 10.
These evaluations will assess indirect efficacy on eggs and evaluate potential re-infestation.
Measured: Treatment time (day 0 - day 10
General well-being of subject (Esthetical effect)
Analysis of subject's (or subject's parents/guardians) questionnaire at day 0 and day 7 to evaluate esthetical effect of the product. A comparison of the answers will be performed between the two products.
Measured: Day 0 and day 7 of the study
Safety by Adverse Events (AEs)
Number and evaluation of Adverse Events (AEs) reported during the study.
Measured: Duration of the study (day 0 - day 10)
Local tolerability on 5-point scales
For both products, evaluation of local tolerability by the dermatologist on 5-point scales including dandruff state, greasy scalp, erythema, desquamation dryness, burning sensation, paraesthesia and pruritus and on 4 point-scales including skin irritation and eye irritation, on D0 (before and after product application), D3 (before and after application), D7 (before and after product application) and D10.
Measured: Duration of study (day 0- day 10)
Global tolerability
For both products, assessment of global tolerability by the dermatologist on day 10 on a 4-point scale.
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study startFeb 2026 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 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
- Prospective, comparative, two-arms, randomized, controlled, investigator/assesor-blinded study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244523
- Sponsor's protocol ID
- OYS013-0025
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Comparative, Two-arms, Randomized, Controlled, Investigator/Assessor-blinded Study for the Evaluation of the Efficacy and Safety of a Medical Device With a Physical Mode of Action (X92001919) Versus Paranic Anti-lice Shampoo on the Treatment of Head Lice Infestation.
- ClinicalTrials.gov ID
- NCT07244523
- Acronym / sponsor ID
- OYS013-0025
- Conditions
- Lice; Head Lice
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Study start
- Feb 2026 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 24 Nov 2025 (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.
Comparison of the efficacy of a new medical device with a physical mode of action to Paranix anti-lice shampoo in the treatment of head lice infestation.
Detailed description
Pediculosis capitis or head lice infestation is a human medical condition caused by the infestation of the hair by the parasitic insect Pediculus humanus capitis (human head lice). When lice feed, they inject saliva into the scalp. The saliva is an anticoagulant which keeps blood from clotting making their feeding process easier. Many individuals experience an allergic reaction to the saliva, causing up to 50% of the population with head lice to itch. For this reason, the most common symptom of infestation is pruritus (itching) on the head. The bite reaction is very mild and it can be rarely seen between the hairs. In rare cases, the itch scratch cycle can lead to secondary infection. Swelling of the local lymph nodes and fever are rare.
There are a range of interventions available for the management of head lice. The main stay of therapy has been largely dependent on insecticidal-based approaches for several decades. However, the accumulating evidence with resistance to frontline insecticidal treatments like pyrethrins, permethrin and malathion has led to a growing incentive to develop newer and more effective treatments to treat the condition safely [3]. Over the past couple of decades, alternative candidates have been introduced into the market, including products with a physical mode of action that works via dehydration and suffocation of the lice [4-8].
The tested product has been developed with the ambition to offer a complete and safe head lice treatment, highly effective against head lice and eggs, whilst also offering ultimate convenience in use - making treatment of head lice infestation easy, and effective in few minutes. This is a medical device, not yet on the market, with a physical mode of action of suffocation and dehydration. The comparator product, Paranix® Anti-Lice Shampoo, is a reference product with a physical mode of action, available on the market in Europe as a class I medical device.
The main objective of the current study is to evaluate the efficacy and safety on head lice treatment of the device X92001919 versus Paranix® Anti-Lice Shampoo comparator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, comparative, two-arms, randomized, controlled, investigator/assesor-blinded study.
| Arm | Type | Receives |
|---|---|---|
| Pulverize (X92001919) | Experimental | Device: Pulverize (X92001919)Treatment with product Pulverize at Visit 1 (Day 0),Visit 2 (Day 3) and Visit 3 (Day 7). Counting alive lice and nymphs in the hair at Visit 1 (Day 0), Visit 2 (Day 3), Visit 3 (Day 7) and Visit 4 (Day 10). |
| Paranix Anti-Lice Shampoo | Active comparator | Device: Paranix Anti-Lice ShampooTreatment with product Paranix Anti-Lice Shampoo at Visit 1 (Day 0) and Visit 3 (Day 7). Counting alive lice and nymphs in the hair at Visit 1 (Day 0), Visit 2 (Day 3), Visit 3 (Day 7) and Visit 4 (Day 10). |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy subject (except head lice infestation) based on medical history;
- Gender: male or female;
- Age: 2 years and above at the time of enrolment ;
- Subject with a slight to moderate lice infestation (according to EU norms)
- Subjects with various hair type (from 1 to 3C in the hair scale below) and hair length (from short to mid length hair, not exceeding shoulder)
Key exclusion criteria (18 listed)
- In terms of population
- In terms of associated pathology 9. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
- 10. Subject with a cutaneous disease on the studied zone (scalp and hair). 11. Subject with severe scratches or open wounds/skin damages on the scalp (lice bites allowed however).
- 12. Subject with a known or suspected allergy to any of the components/materials of the investigational products, anti-lice comb or post- treatment shampoo.
- 13. Subject who has diabetes (type 1 or 2). 14. Subject with known or suspected immune deficiency or autoimmune disease.
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 |
|---|---|---|
| Pulverize (X92001919)Treatment at Day 0, Day 3 and Day 7 with the Pulverize Dry Shampoo formulation (X92001919) | Device | Pulverize (X92001919) |
| Paranix Anti-Lice ShampooTreatment at Day 0 and Day 7 with the Paranix Anti-Lice Shampoo | Device | Paranix Anti-Lice Shampoo |
Primary outcome
Efficacy of Pulverize (X92001919) compared to the comparator Paranix Anti-Lice Shampo.
Time frame: 10 days
Evaluate the efficacy of Pulverize (X92001919) compared to the comparator Paranix Anti-Lice Shampoo on the treatment of head lice infestation, after one treatment consisting of 3 applications. Efficacy of the treatment will be defined as the cure rate at the end of day 10, corrected for re-infestation.
7 secondary outcomes
Efficacy comparison (uncorrected for re-infestation)
Time frame: 10 days
Cure rate on day 3 and day 7
Time frame: day 3 for cure rate of first application day 7/day 10 for second application (depending on treatment).
Indirect efficacy on eggs and evaluate potential re-infestation
Time frame: Treatment time (day 0 - day 10
General well-being of subject (Esthetical effect)
Time frame: Day 0 and day 7 of the study
Safety by Adverse Events (AEs)
Time frame: Duration of the study (day 0 - day 10)
Local tolerability on 5-point scales
Time frame: Duration of study (day 0- day 10)
Global tolerability
Time frame: Day 10
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 24 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Lice; Head Lice
Recruiting
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
Lice; Head Lice
Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
Headlice
Recruiting
Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
Head Lice
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.
Questions about this trial
What is this clinical trial studying?
A study testing Pulverize (X92001919) in people with Lice; Head Lice, run by Oystershell NV.
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 18 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: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Aslham Doarika, Dr. (+2304670231, dr@insight-research.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Pulverize (X92001919) compared to the comparator Paranix Anti-Lice Shampo. (time frame: 10 days). 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 24 Nov 2025.