Comparative Study for the Evaluation of a New Medical Device on the Treatment of Head Lice Infestation

Last updated: May 31, 2022
Sponsor: Perrigo CSCI
Overall Status: Active - Recruiting

Phase

N/A

Condition

Head Lice

Treatment

N/A

Clinical Study ID

NCT05379114
20E4084
  • Ages > 2
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 (fromshort to mid length hair, not exceeding shoulder)
  6. Documented oral informed consent for all subjects, including minors, given freely andexpressly before the start of the study
  7. Written informed consent for subjects ≥18 years or legal guardian for subjects< 18years 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 studyrelated information and to give written informed consent;
  10. Females of childbearing potential must have a negative pregnancy test before thebeginning of the study

Exclusion

Exclusion Criteria: In terms of population

  1. Pregnant (confirmed by pregnancy test for women of childbearing potential) or nursingwoman or planning a pregnancy during the study;
  2. Subject who had been deprived of their freedom by administrative or legal decision oradult 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 participatingto another study on hair/scalp or who participated to another clinical study onhair/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 mayinterfere 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 bitesallowed however).
  12. Subject with a known or suspected allergy to any of the components/materials of theinvestigational 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 weeksand during the study;
  • corticosteroids during the 2 previous weeks and during the study;
  • retinoids and/or immunosuppressors during the 3 previous months and during thestudy;
  • any medication stabilized for less than one month.
  1. Subject who received an anti-lice treatment in the previous 2 months.

Study Design

Total Participants: 136
Study Start date:
May 18, 2022
Estimated Completion Date:
September 30, 2022

Connect with a study center

  • Céline Lhéritier

    Quatre Bornes,
    Mauritius

    Active - Recruiting

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