Effectiveness of No More Anti-lice Medical Device to Kill Lice and Lice Eggs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine effectiveness of an Anti-lice treatment using the medical device No More which is designed to kill lice and lice eggs on the head.

Detailed Description
-----------------
The Clinical Trial Protocol include 2 visits First Visit: Explanation and signing of consent forms. Diagnosis: Prof. Shemer will check if the patients have sufficient living lice or lice eggs and if so they will be scheduled to receive treatment. Second Visit: -Spread the No More on the head of the boy or girl on dry hair. After five minutes comb with an adequately thick comb and the eggs will fall out easily with the pulling of the comb. Wash the hair. Combing the hair again with a thick comb for five minutes and/or 20 combings; Checking if the head is free of eggs and lice via a visual inspection by the head researcher. Outcome If there are no live eggs and/or lice then the patient has completed treatment - and the research. (This outcome is defined as successful treatment.) If there are eggs only then the patient is scheduled for a third visit after seven days (+/- one day). If live lice are found this outcome is defined as failure and the patient will not be scheduled for an additional visit Third Visit: After seven days (+/- one day) Professor Shemer will conduct a visual inspection for lice and lice eggs. Combing with a thick comb for five minutes and/or 20 combings and if there are live lice or lice eggs Treatment Success: No eggs and no lice immediately with the end of the treatment (second visit). No lice or live lice eggs after seven days (+/- one day). Number of Participants: Up to 80 participants when at least 50 participants complete the treatment. Age Range: 3-18 years

Official Title
-----------------
Clinical Trial of Anti-Lice Treatment Using the Medical Device No More Which is Designed to Kill Lice and Lice Eggs on the Head.

Conditions
-----------------
Lice

Intervention / Treatment
-----------------
* Device: Topically


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that are suffering from lice and lice eggs that agree to refrain from any other treatment or salve designed for the treatment of lice and/or lice eggs throughout the course of the research study. Patients that orally and in writing express their agreement to participate in the study - Consent in writing will be provided by two parents; Oral consent will be provided by the participants themselves. Exclusion Criteria: Pregnant or nursing women. Patients lacking the faculties for proper judgment.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Topically|use the No More medical device as anti lice treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No live lice eggs and/or live lice |  | 1 day from second visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti-lice treatment