Comparative Study for the Evaluation of a New Medical Device on the Treatment of Head Lice Infest… (NCT05379114) | Clinical Trial Compass
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Comparative Study for the Evaluation of a New Medical Device on the Treatment of Head Lice Infestation
Mauritius136 participantsStarted 2022-05-18
Plain-language 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 symptom of infestation is pruritus (itching) on the head which normally intensifies 3 to 4 weeks after the initial infestation.
The test item has been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimate convenience in use - making treatment of head lice infestation easy, and effective in few minutes.
The objectives of this clinical study are to assess the efficacy and the safety of a new Medical Device for lice infestation treatment compared to a comparator device, already in market.
Who can participate
Age range2 Years
SexALL
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Inclusion criteria
✓. Healthy subject;
✓. Sex: male or female;
✓. Age: 2 years and above;
✓. Subject with a slight to moderate lice infestation
✓. 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.
Exclusion criteria
✕. 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 to 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 (type 4a to 4c in the hair type scale above)