Status:
UNKNOWN
Comparative Study for the Evaluation of Two Medical Devices on the Treatment of Head Lice Infestation
Lead Sponsor:
Perrigo CSCI
Conditions:
Head Lice Infestation
Eligibility:
All Genders
2+ years
Phase:
NA
Brief Summary
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). The most common sym...
Eligibility Criteria
Inclusion
- Healthy subject;
- Sex: male or female;
- Age: 2 years and above;
- Subject with a slight to moderate lice infestation (according to EU norms);
- Subjects with various hair type (from 1 to 3C - hair scale) 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.
Exclusion
- Pregnant (confirmed by pregnancy test 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;
- Subject with curly or frizzy hair (from 4A to 4C in the hair type scale);
- Subject with hair length below the shoulder;
- Subjects with more than 24 lice on the head.
- In terms of associated pathology
- 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);
- 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 devices, anti-lice comb or post-treatment shampoo;
- Subject who has diabetes (type 1 or 2);
- Subject with known or suspected immune deficiency or autoimmune disease.
- Relating to previous or ongoing treatment
- 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.
- Subject who received an anti-lice treatment in the previous 2 months.
Key Trial Info
Start Date :
August 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT06057506
Start Date
August 21 2023
End Date
November 1 2023
Last Update
September 28 2023
Active Locations (1)
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1
Insight Research
Quatre Bornes, Mauritius