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

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ClinicalTrials.gov Identifier: NCT02569580
Recruitment Status : Unknown
Verified October 2015 by Pharmayeda.
Recruitment status was:  Recruiting
First Posted : October 7, 2015
Last Update Posted : October 7, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Lice Device: Topically Not Applicable

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.


  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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Intervention Details:
  • Device: Topically
    use the "No More" medical device as anti lice treatment

Primary Outcome Measures :
  1. No live lice eggs and/or live lice [ Time Frame: 1 day from second visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569580

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Contact: Orna Levin, Dr 972-525286000 "Dr. Orna Levin" <dr.ornal@pharmayeda-ind.co.il>
Contact: orly simhony 972-528747434 orly@pharmayeda-ind.co.il

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Prof. Avner Shemer clinic Recruiting
Netanya, Israel, 42150
Contact: Ben Berger    972-545679344    ben@medicly.com   
Contact: Miriyam Srur    09-8657777      
Principal Investigator: avner S Shemer, Prof.         
Sponsors and Collaborators
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Study Director: Ben Berger Prof. Avner Shemer clinic
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Responsible Party: Pharmayeda
ClinicalTrials.gov Identifier: NCT02569580    
Other Study ID Numbers: 0022-14-LND
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015
Keywords provided by Pharmayeda:
anti-lice treatment
Additional relevant MeSH terms:
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Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases