Clinical trial NCT05379114: Comparative Study for the Evaluation of a New Medical Device on the Treatment of Head Lice Infestation
Official title: Comparative, Monocentric Study for the Evaluation of the Non-inferiority of a New Medical Device on the Treatment of Head Lice Infestation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head Lice
Lead sponsor: Perrigo CSCI
Sponsor class: INDUSTRY
First posted: 2022-05-18
Enrollment: 136
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

1. Healthy subject;
2. Sex: male or female;
3. Age: 2 years and above;
4. Subject with a slight to moderate lice infestation
5. Subjects with various hair type (from 1 to 3C - hair scale) and hair length (from short to mid length hair, not exceeding shoulder)
6. Documented oral informed consent for all subjects, including minors, given freely and expressly before the start of the study
7. Written informed consent for subjects ≥18 years or legal guardian for subjects\< 18 years given freely and expressly before start of the study;
8. Written assent for subjects ≥12 to \<18 years.
9. Subject/Subject's legal guardian is psychologically able to understand the study related information and to give written informed consent;
10. Females of childbearing potential must have a negative pregnancy test before the beginning of the study

Exclusion Criteria:

In terms of population

1. Pregnant (confirmed by pregnancy test for women of childbearing potential) or nursing woman or planning a pregnancy during the study;
2. Subject who had been deprived of their freedom by administrative or legal decision or adult subject who is under guardianship;
3. Subject in a social or sanitary establishment;
4. 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.
5. Subject suspected to be non-compliant according to the Investigator's judgment.
6. Subject with curly or frizzy hair (type 4a to 4c in the hair type scale above)
7. Subject with hair length below the shoulder.
8. 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.
10. 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).
12. 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.
13. 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;
    * retinoids and/or immunosuppressors during the 3 previous months and during the study;
    * any medication stabilized for less than one month.
16. Subject who received an anti-lice treatment in the previous 2 months.

Primary outcomes:
measure: Cure Rate after complete treatment
timeFrame: day 7
measure: Cure Rate after complete treatment
timeFrame: day 14
Secondary outcomes:
measure: Cure rate after one dose of Investigational device (ID)
timeFrame: Day 7
measure: Dead and live lice/nymphs and number of eggs after combing
timeFrame: Day 0 and Day 7 if applicable
measure: Live lice and nymphs, after application
timeFrame: Day 1 and Day 8 if applicable
measure: Number of participants with treatment-related adverse events as assessed by investigator
timeFrame: Day 0, 7, 8 and 14 if applicable
measure: Subject reported perceived acceptability, effectiveness and subjective evaluation assessed via questionnaire data
timeFrame: Day 7 or Day14
Other outcomes:
Locations:
city: Quatre Bornes
country: Mauritius
facility: Céline Lhéritier
Study officials:
References: