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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02569580
Other study ID # 0022-14-LND
Secondary ID
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"
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT04878276 - Comparative Head Lice Therapy With Dimet 5® vs. Hedrin® Once