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

Lice Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02569580
• Other study ID #: 0022-14-LND
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2015
• Last updated: October 6, 2015
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: Pharmayeda
• Contact: Orna Levin, Dr
• Phone: 972-525286000
• Email: "Dr. Orna Levin" [@]pharmayeda-ind.co.il>
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lice
• Lice Infestations

Intervention

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

Locations

Country	Name	City	State
Israel	Prof. Avner Shemer clinic	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Pharmayeda

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No live lice eggs and/or live lice		1 day from second visit	No