Back to resultsEffectiveness of "No More" Anti-lice Medical Device to Kill Lice and Lice Eggs
Primary Purpose
Lice
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Topically
Sponsored by
About this trial
This is an interventional treatment trial for Lice focused on measuring anti-lice treatment
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.
Sites / Locations
- Prof. Avner Shemer clinicRecruiting
Outcomes
Primary Outcome Measures
No live lice eggs and/or live lice
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02569580
Brief Title
Effectiveness of "No More" Anti-lice Medical Device to Kill Lice and Lice Eggs
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmayeda
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lice
Keywords
anti-lice treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Topically
Intervention Description
use the "No More" medical device as anti lice treatment
Primary Outcome Measure Information:
Title
No live lice eggs and/or live lice
Time Frame
1 day from second visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Orna Levin, Dr
Phone
972-525286000
Email
"Dr. Orna Levin" <dr.ornal@pharmayeda-ind.co.il>
First Name & Middle Initial & Last Name or Official Title & Degree
orly simhony
Phone
972-528747434
Email
orly@pharmayeda-ind.co.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Berger
Organizational Affiliation
Prof. Avner Shemer clinic
Official's Role
Study Director
Facility Information:
Facility Name
Prof. Avner Shemer clinic
City
Netanya
ZIP/Postal Code
42150
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben Berger
Phone
972-545679344
Email
ben@medicly.com
First Name & Middle Initial & Last Name & Degree
Miriyam Srur
Phone
09-8657777
First Name & Middle Initial & Last Name & Degree
avner S Shemer, Prof.
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of "No More" Anti-lice Medical Device to Kill Lice and Lice Eggs
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