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

NCT07244523 | Not Yet Recruiting

• 1 other identifier: OYS013-0025
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lice; Head Lice

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Efficacy comparison (uncorrected for re-infestation)

  10 days

• Cure rate on day 3 and day 7

  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

  Treatment time (day 0 - day 10

• General well-being of subject (Esthetical effect)

  Day 0 and day 7 of the study

• Safety by Adverse Events (AEs)

  Duration of the study (day 0 - day 10)

Study Arms (2)

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).

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).

Device: Paranix Anti-Lice Shampoo

Interventions

Pulverize (X92001919) DEVICE

Treatment at Day 0, Day 3 and Day 7 with the Pulverize Dry Shampoo formulation (X92001919)

Pulverize (X92001919)

Paranix Anti-Lice Shampoo DEVICE

Treatment at Day 0 and Day 7 with the Paranix Anti-Lice Shampoo

Paranix Anti-Lice Shampoo

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 suspected to be non-compliant according to the Investigator's judgment.
• 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.
• \. 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).
• \. Subject with a known or suspected allergy to any of the components/materials of the investigational products, anti-lice comb or post- treatment shampoo.
• \. 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;

Sponsors & Collaborators

• Oystershell NV: lead
• Eurofins Dermscan Pharmascan: collaborator

MeSH Terms

Conditions

Lice Infestations

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Aslham Doarika, Dr.

CONTACT

+2304670231; dr@insight-research.com

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: Prospective, comparative, two-arms, randomized, controlled, investigator/assesor-blinded study.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: February 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share