Effectiveness of "No More" Anti-lice Medical Device to Kill Lice and Lice Eggs
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|ClinicalTrials.gov Identifier: NCT02569580|
Recruitment Status : Unknown
Verified October 2015 by Pharmayeda.
Recruitment status was: Recruiting
First Posted : October 7, 2015
Last Update Posted : October 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lice||Device: Topically||Not Applicable|
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.
- 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
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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||December 2016|
- No live lice eggs and/or live lice [ Time Frame: 1 day from second visit ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569580
|Contact: Orna Levin, Dr||972-525286000||"Dr. Orna Levin" <firstname.lastname@example.org>|
|Contact: orly email@example.com|
|Prof. Avner Shemer clinic||Recruiting|
|Netanya, Israel, 42150|
|Contact: Ben Berger 972-545679344 firstname.lastname@example.org|
|Contact: Miriyam Srur 09-8657777|
|Principal Investigator: avner S Shemer, Prof.|
|Study Director:||Ben Berger||Prof. Avner Shemer clinic|