[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611741":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":37,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":25,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":25,"enrollmentInfo":49,"targetDuration":25,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":25,"overallStatus":58,"whyStopped":25,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":25},{"fullName":5,"class":6},"Oystershell NV","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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).",[13],"Device: Pulverize (X92001919)",{"label":15,"type":16,"description":17,"interventionNames":18},"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).",[19],"Device: Paranix Anti-Lice Shampoo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Treatment at Day 0, Day 3 and Day 7 with the Pulverize Dry Shampoo formulation (X92001919)",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Treatment at Day 0 and Day 7 with the Paranix Anti-Lice Shampoo",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Aslham Doarika, Dr.","CONTACT","+2304670231","dr@insight-research.com",{"type":36,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[38],{"name":39,"class":6},"Eurofins Dermscan Pharmascan","100611741","efficacy-and-safetyof-a-medical-device-with-a-physical-mode-of-action-x92001919-versus-paranix-anti-lice-shampoo-100611741",false,"NCT07244523","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\u002FAssessor-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.","Inclusion Criteria:\n\n* Healthy subject (except head lice infestation) based on medical history;\n* Gender: male or female;\n* Age: 2 years and above at the time of enrolment ;\n* Subject with a slight to moderate lice infestation (according to EU norms)\n* 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)\n* Documented oral informed consent for all subjects, including minors, given freely and expressly before the start of the study\n* Written informed consent for subjects ≥18 years or legal guardian for subjects \\\u003C 18 years given freely and expressly before start of the study;\n* Written assent for subjects ≥12 to \\\u003C18 years.\n* Subject\u002FSubject's legal guardian is psychologically able to understand the study related information and to give written informed consent;\n* 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.\n* Subject agrees not to cut or chemically treat their hair while participating in the study.\n* Subjects agrees not to use any other anti-lice treatment or medicated hair grooming products for the duration of the study.\n\nExclusion Criteria:\n\n* In terms of population\n\n  1. Pregnant (confirmed by pregnancy test at D0 for women of childbearing potential) or nursing woman or planning a pregnancy during the study;\n  2. Subject who had been deprived of their freedom by administrative or legal decision or adult subject who is under guardianship;\n  3. Subject in a social or sanitary establishment;\n  4. Subject in an exclusion period from a previous study or who is currently participating in another study on hair\u002Fscalp or who participated to another clinical study on hair\u002Fscalp within 3 months before first visit.\n  5. Subject suspected to be non-compliant according to the Investigator's judgment.\n  6. Subject with curly or frizzy hair (from 4A to 4C in the hair type scale above).\n  7. Subject with hair length below the shoulder.\n  8. Subjects with more than 24 lice on the head.\n* 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.\n\n  10\\. Subject with a cutaneous disease on the studied zone (scalp and hair). 11. Subject with severe scratches or open wounds\u002Fskin damages on the scalp (lice bites allowed however).\n\n  12\\. Subject with a known or suspected allergy to any of the components\u002Fmaterials of the investigational products, anti-lice comb or post- treatment shampoo.\n\n  13\\. Subject who has diabetes (type 1 or 2). 14. Subject with known or suspected immune deficiency or autoimmune disease.\n* Relating to previous or ongoing treatment 15. Subject undergoing a topical treatment on the test area or a systemic treatment with:\n\n  * anti-inflammatory medication and\u002For anti-histamines during the previous 2 weeks and during the study;\n  * corticosteroids during the 2 previous weeks and during the study;\n  * retinoids and\u002For immunosuppressors during the 3 previous months and during the study;\n  * any medication stabilized for less than one month. 16. Subject who received an anti-lice treatment in the previous 2 months.","ALL","2 Years",{"count":50,"type":51},34,"ESTIMATED","INTERVENTIONAL",[54],"NA","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.",[57],"Lice; Head Lice","NOT_YET_RECRUITING","2025-11-17",{"date":61,"type":62},"2025-11-24","ACTUAL",{"date":64,"type":51},"2026-02",{"date":66,"type":51},"2026-04",{"name":5,"class":6}]