Status:
UNKNOWN
Comparative Study for the Evaluation of a New Medical Device on the Treatment of Head Lice Infestation
Lead Sponsor:
Perrigo CSCI
Conditions:
Head Lice
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
- 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
- In terms of population
- 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)
- 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 or comparator 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 :
May 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT05379114
Start Date
May 18 2022
End Date
September 1 2022
Last Update
June 1 2022
Active Locations (1)
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1
Céline Lhéritier
Quatre Bornes, Mauritius