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

September 26, 2023 updated by: Perrigo CSCI

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Manon Laune
  • Phone Number: +33 (0)4 72 82 36 56 4409
  • Email: mla@dermscan.com

Study Locations

  • Mauritius
      • Quatre Bornes, Mauritius
        • Recruiting
        • Insight Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 7, Day 14 if applicable

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure rate of each individual investigational device
Time Frame: Day 7, Day 14
Evaluate the cure rate of each individual investigational device
Day 7, Day 14
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.
Day 7
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.
Day 0, Day 7 if applicable
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
Day 1, Day 7, Day 8 if applicable, Day 14 if applicable
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
Day 0, Day 1, Day 7, Day 8 if applicable, and Day 14 if applicable
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
Day 1, Day 7 or Day 14 if applicable

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perrigo CSCI

Investigators

  • Principal Investigator: Aslham Doarika, PhD, Insight Collective

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22E1852

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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