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Comparative Study for the Evaluation of Two Medical Devices on the Treatment of Head Lice Infestation

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ClinicalTrials.gov Identifier: NCT06057506
Recruitment Status : Recruiting
First Posted : September 28, 2023
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Perrigo CSCI

Study Description
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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 items have been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimative convenience in use - making treatment of head lice infestation easy, and effective in few minutes.

The main objective of this clinical study is to confirm the efficacy on head lice treatment of two Medical Devices, already in market.


Condition or disease Intervention/treatment Phase
Head Lice Infestation Device: Paranix® Shampoo Device: Paranix® Lotion Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative, Monocentric Study for the Evaluation of the Efficacy of Two Medical Devices on the Treatment of Head Lice Infestation
Actual Study Start Date : August 21, 2023
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Investigational Device

Medical device for the treatment of head lice infestation: Paranix® Shampoo, already in the market in Europe

Single topical application administered to hair and scalp for 10 minutes. Applied by principal investigator on site.

 Device: Paranix® Shampoo
well established medical device for the treatment of head lice infestation (osmolone based)
Active Comparator: Comparator Device

Medical device for the treatment of head lice infestation: Paranix® Lotion, already in the market in Europe

Single topical application administered to hair and scalp for 10 minutes. Applied by principal investigator on site.

 Device: Paranix® Lotion
well established medical device for the treatment of head lice infestation (dimethicone based)


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy based on the cure rate after complete treatment [ Time Frame: Day 7, Day 14 if applicable ]
    The cure rate is defined as the rate of subjects having no live lice on hair 7 days after the last application of the product (Day 7 or Day 14 if second application is needed).


Secondary Outcome Measures :
  1. Cure rate of each individual investigational device [ Time Frame: Day 7, Day 14 ]
    Evaluate the cure rate of each individual investigational device

  2. Cure rate after one dose of investigational device application [ Time Frame: Day 7 ]
    Comparison of the percentage of subjects cured after one dose of the investigational device compared to the percentage of subjects cured with one dose of the comparator device.

  3. Dead and live lice/nymphs after combing [ Time Frame: Day 0, Day 7 if applicable ]
    Number of dead and live lice/nymphs collected on the anti-lice comb after treatment.

  4. Live lice and nymphs after application [ Time Frame: Day 1, Day 7, Day 8 if applicable, Day 14 if applicable ]
    Evaluation of the presence of live lice and nymphs, for both groups, without combing on hair and close to scalp

  5. Number of participants with treatment-related adverse events, serious adverse events as assessed by investigator [ Time Frame: Day 0, Day 1, Day 7, Day 8 if applicable, and Day 14 if applicable ]
    Evaluation of the safety and tolerability of the investigational device versus comparator

  6. Subject reported perceived acceptability, efficacy and subjective evaluation assessed via questionnaire [ Time Frame: Day 1, Day 7 or Day 14 if applicable ]

    Evaluation of the perceived acceptability, subjective efficacy and risk of re-infestation;

    Subject perception questionnaire with the following scale items:

    totally agree, agree, rather disagree, disagree



Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06057506


Contacts
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Contact: Manon Laune +33 (0)4 72 82 36 56 4409 mla@dermscan.com

Locations
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Mauritius
Insight Research Recruiting
Quatre Bornes, Mauritius
Contact: Manon Laune    +33 (0)4 72 82 36 56 4409    mla@dermscan.com   
Sponsors and Collaborators
Perrigo CSCI
Investigators
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Principal Investigator: Aslham Doarika, PhD Insight Collective
More Information
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Responsible Party: Perrigo CSCI
ClinicalTrials.gov Identifier: NCT06057506    
Other Study ID Numbers: 22E1852
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Perrigo CSCI:
Head Lice Infestation
Pediculosis capitis
Additional relevant MeSH terms:
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Lice Infestations
Parasitic Diseases
Mite Infestations
Ectoparasitic Infestations
 Skin Diseases, Parasitic
Infections
Skin Diseases, Infectious
Skin Diseases