Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lice; Head Lice
• Intervention / Treatment: Device: Pulverize (X92001919); Device: Paranix Anti-Lice Shampoo

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 Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aslham Doarika, Dr.; Phone Number: +2304670231; Email: dr@insight-research.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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.

Exclusion Criteria:

• In terms of population

  1. Pregnant (confirmed by pregnancy test at D0 for women of childbearing potential) or nursing woman or planning a pregnancy during the study;
  2. Subject who had been deprived of their freedom by administrative or legal decision or adult subject who is under guardianship;
  3. Subject in a social or sanitary establishment;
  4. 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.
  5. Subject suspected to be non-compliant according to the Investigator's judgment.
  6. Subject with curly or frizzy hair (from 4A to 4C in the hair type scale above).
  7. Subject with hair length below the shoulder.
  8. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: Pulverize (X92001919); Treatment at Day 0, Day 3 and Day 7 with the Pulverize Dry Shampoo formulation (X92001919)
Active Comparator: Paranix Anti-Lice Shampoo; 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).	Device: Paranix Anti-Lice Shampoo; Treatment at Day 0 and Day 7 with the Paranix Anti-Lice Shampoo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	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.	Day 0 and day 7 of the study
Safety by Adverse Events (AEs)	Number and evaluation of Adverse Events (AEs) reported during the study.	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.	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.	Day 10

Collaborators and Investigators

• Sponsor: Oystershell NV
• Collaborators: Eurofins Dermscan Pharmascan

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Skin Diseases; Skin Diseases, Infectious; Skin Diseases, Parasitic; Ectoparasitic Infestations; Skin and Connective Tissue Diseases; Lice Infestations
• Other Study ID Numbers: OYS013-0025

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