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

Primary Purpose

Head Lice Infestation

Status
Recruiting
Phase
Not Applicable
Locations
Mauritius
Study Type
Interventional
Intervention
Paranix® Shampoo
Paranix® Lotion
Sponsored by
Perrigo CSCI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Lice Infestation focused on measuring Head Lice Infestation, Pediculosis capitis

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Insight ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational Device

Comparator Device

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Efficacy based on the cure rate after complete treatment
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

Cure rate of each individual investigational device
Evaluate the cure rate of each individual investigational device
Cure rate after one dose of investigational device application
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.
Dead and live lice/nymphs after combing
Number of dead and live lice/nymphs collected on the anti-lice comb after treatment.
Live lice and nymphs after application
Evaluation of the presence of live lice and nymphs, for both groups, without combing on hair and close to scalp
Number of participants with treatment-related adverse events, serious adverse events as assessed by investigator
Evaluation of the safety and tolerability of the investigational device versus comparator
Subject reported perceived acceptability, efficacy and subjective evaluation assessed via questionnaire
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

Full Information

First Posted
August 30, 2023
Last Updated
September 26, 2023
Sponsor
Perrigo CSCI
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1. Study Identification

Unique Protocol Identification Number
NCT06057506
Brief Title
Comparative Study for the Evaluation of Two Medical Devices on the Treatment of Head Lice Infestation
Official Title
Comparative, Monocentric Study for the Evaluation of the Efficacy of Two Medical Devices on the Treatment of Head Lice Infestation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Perrigo CSCI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Lice Infestation
Keywords
Head Lice Infestation, Pediculosis capitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational Device
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparator Device
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Paranix® Shampoo
Intervention Description
well established medical device for the treatment of head lice infestation (osmolone based)
Intervention Type
Device
Intervention Name(s)
Paranix® Lotion
Intervention Description
well established medical device for the treatment of head lice infestation (dimethicone based)
Primary Outcome Measure Information:
Title
Efficacy based on the cure rate after complete treatment
Description
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).
Time Frame
Day 7, Day 14 if applicable
Secondary Outcome Measure Information:
Title
Cure rate of each individual investigational device
Description
Evaluate the cure rate of each individual investigational device
Time Frame
Day 7, Day 14
Title
Cure rate after one dose of investigational device application
Description
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.
Time Frame
Day 7
Title
Dead and live lice/nymphs after combing
Description
Number of dead and live lice/nymphs collected on the anti-lice comb after treatment.
Time Frame
Day 0, Day 7 if applicable
Title
Live lice and nymphs after application
Description
Evaluation of the presence of live lice and nymphs, for both groups, without combing on hair and close to scalp
Time Frame
Day 1, Day 7, Day 8 if applicable, Day 14 if applicable
Title
Number of participants with treatment-related adverse events, serious adverse events as assessed by investigator
Description
Evaluation of the safety and tolerability of the investigational device versus comparator
Time Frame
Day 0, Day 1, Day 7, Day 8 if applicable, and Day 14 if applicable
Title
Subject reported perceived acceptability, efficacy and subjective evaluation assessed via questionnaire
Description
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
Time Frame
Day 1, Day 7 or Day 14 if applicable

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manon Laune
Phone
+33 (0)4 72 82 36 56 4409
Email
mla@dermscan.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aslham Doarika, PhD
Organizational Affiliation
Insight Collective
Official's Role
Principal Investigator
Facility Information:
Facility Name
Insight Research
City
Quatre Bornes
Country
Mauritius
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manon Laune
Phone
+33 (0)4 72 82 36 56 4409
Email
mla@dermscan.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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