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.
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.
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
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04878276 -
Comparative Head Lice Therapy With Dimet 5® vs. Hedrin® Once
|