Effectiveness of "No More" Anti-lice Medical Device to Ki... | NCT02569580

Studies
Effectiveness of "No More" Anti-lice Medical Device to Kill Lice and Lice Eggs

NCT02569580

Sponsor

Pharmayeda

Status

Unknown status

Last Update Posted

Oct 7, 2015Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Lice

Interventions

Topically

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Oct 6, 2015

First Submission Date that Met QC Criteria

Oct 6, 2015

First Posted Date

Oct 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2015

Last Update Posted Date

Oct 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Topically	Device	use the "No More" medical device as anti lice treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
No live lice eggs and/or live lice		1 day from second visit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Orna Levin, Dr	Contact	972-525286000		"Dr. Orna Levin" <dr.ornal@pharmayeda-ind.co.il>
orly simhony	Contact	972-528747434		orly@pharmayeda-ind.co.il

Overall Officials

Name	Affiliation	Role
Ben Berger	Prof. Avner Shemer clinic	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof. Avner Shemer clinic	Recruiting	Netanya		42150	Israel

Condition Browse Module

MeSH Terms

ID	Term
D010373	Lice Infestations

Ancestor Terms

ID	Term
D004478	Ectoparasitic Infestations
D012876	Skin Diseases, Parasitic
D010272	Parasitic Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided