Clinical Trial of Anti-Lice Treatment Using the Medical Device "No More" Which is Designed to Kill Lice and Lice Eggs on the Head.
Overview
- Phase
- Not Applicable
- Sponsor
- Pharmayeda
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- No live lice eggs and/or live lice
Overview
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.
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
- 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.)
- If there are eggs only then the patient is scheduled for a third visit after seven days (+/- one day).
- 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
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
No live lice eggs and/or live lice
Time Frame: 1 day from second visit
Secondary Outcomes
No secondary outcomes reported