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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.


Clinical Trial 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

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


Related Conditions & MeSH terms


NCT number NCT02569580
Study type Interventional
Source Pharmayeda
Contact Orna Levin, Dr
Phone 972-525286000
Email "Dr. Orna Levin" <dr.ornal@pharmayeda-ind.co.il>
Status Recruiting
Phase N/A
Start date October 2015
Completion date December 2016

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