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

Recruitment & Eligibility

Status: UNKNOWN

Sex: All

Target Recruitment: 136

Inclusion Criteria

Healthy subject;
Sex: male or female;
Age: 2 years and above;
Subject with a slight to moderate lice infestation
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

In terms of population

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 to 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 (type 4a to 4c in the hair type scale above)
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 or comparator 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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INVESTIGATIONAL DEVICE	INVESTIGATIONAL DEVICE	new medical device for the treatment of head lice infestation: Paranix ®
COMPARATOR DEVICE	Comparator device	dimethicone based head lice treatment (medical device class 1) already in market in europe: Pouxit ®

Primary Outcome Measures

Name	Time	Method
Cure Rate after complete treatment	day 14	The cure rate is defined as the rate of subjects having no live lice on scalp 7 days after the last application of the product.

Secondary Outcome Measures

Name	Time	Method
Live lice and nymphs, after application	Day 1 and Day 8 if applicable	Evaluation of the presence of live lice and nymphs, for both groups, without combing on scalp
Dead and live lice/nymphs and number of eggs after combing	Day 0 and Day 7 if applicable	Number of dead and live lice/nymphs and number of eggs collected on the anti-lice comb after treatment
Number of participants with treatment-related adverse events as assessed by investigator	Day 0, 7, 8 and 14 if applicable	Evaluation of the safety and tolerability of the investigational device versus comparator
Cure rate after one dose of Investigational device (ID)	Day 7	Comparison of the percentage of subjects cured after one dose of the investigational device compared to the percentage of subjects cured with two doses of the comparator device.
Subject reported perceived acceptability, effectiveness and subjective evaluation assessed via questionnaire data	Day 7 or Day14	Evaluation of the perceived acceptability, effectiveness and subjective evaluation. Subject perception questionnaire with the following scale items: totally agree agree rather agree rather disagree disagree

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

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

Instant Trial Alerts