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

Study Overview
=================
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.

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

Conditions
-----------------
Head Lice Infestation

Intervention / Treatment
-----------------
* Device: Paranix® Shampoo
* Device: Paranix® Lotion


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Device<br>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<br>* well established medical device for the treatment of head lice infestation (osmolone based)<br>|
| Active Comparator: Comparator Device<br>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<br>* well established medical device for the treatment of head lice infestation (dimethicone based)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate of each individual investigational device | Evaluate the cure rate of each individual investigational device | Day 7, Day 14 | 
| 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. | Day 7 | 
| Dead and live lice/nymphs after combing | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediculosis capitis, Head Lice Infestation