LiceNCT02569580
Effectiveness of "No More" Anti-lice Medical Device to Kill Lice and Lice Eggs
A study testing Topically in people with Lice, run by Pharmayeda at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Lice
- What is being tested?
- Topically
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or nursing women.
- Patients lacking the faculties for proper judgment.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Prof. Avner Shemer clinic
Netanya, 42150
Ben Berger, 972-545679344, ben@medicly.com
Miriyam Srur, 09-8657777
About this study
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.
Read the 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
- Conditions
- Lice
- Being tested
- Topically
- Keywords
- anti-lice treatment
- Medical subject headings
- Lice Infestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopicallyDevice
use the "No More" medical device as anti lice treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
No live lice eggs and/or live lice
Measured: 1 day from second visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmayeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Berger, Study director, Prof. Avner Shemer clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569580
- Sponsor's protocol ID
- 0022-14-LND
- Status last verified
- Oct 2015
- First submitted
- 6 Oct 2015
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02569580
- Acronym / sponsor ID
- 0022-14-LND
- Conditions
- Lice
- Keywords
- anti-lice treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- PharmayedaIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant or nursing women.
- Patients lacking the faculties for proper judgment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topicallyuse the "No More" medical device as anti lice treatment | Device | – |
Primary outcome
No live lice eggs and/or live lice
Time frame: 1 day from second visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Berger study director
Prof. Avner Shemer clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topically in people with Lice, run by Pharmayeda at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orna Levin, Dr (972-525286000, "Dr. Orna Levin" <dr.ornal@pharmayeda-ind.co.il>), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No live lice eggs and/or live lice (time frame: 1 day from second visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.