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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Lice Device: Topically

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

  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


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lice
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Contacts and Locations

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


Contacts
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

Locations
Israel
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
Pharmayeda
Investigators
Study Director: Ben Berger Prof. Avner Shemer clinic
More Information

Responsible Party: Pharmayeda
ClinicalTrials.gov Identifier: NCT02569580     History of Changes
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