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

NCT ID: NCT02569580

Last Updated: 2015-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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

1. 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.)
2. If there are eggs only then the patient is scheduled for a third visit after seven days (+/- one day).
3. 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

Conditions

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Lice

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Topically

use the "No More" medical device as anti lice treatment

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pharmayeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ben Berger

Role: STUDY_DIRECTOR

Prof. Avner Shemer clinic

Locations

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Prof. Avner Shemer clinic

Netanya, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Orna Levin, Dr

Role: CONTACT

orly simhony

Role: CONTACT

972-528747434

Facility Contacts

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Ben Berger

Role: primary

972-545679344

Miriyam Srur

Role: backup

09-8657777

Other Identifiers

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0022-14-LND

Identifier Type: -

Identifier Source: org_study_id

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