Treatment of Head Lice Infestation Using Novel Ultrasonic... | NCT02854878

Studies
Treatment of Head Lice Infestation Using Novel Ultrasonic Comb

NCT02854878

Sponsor

ParaSonic Ltd.

Status

Completed

Last Update Posted

Mar 29, 2019Actual

Enrollment

23Actual

Phase

Not Applicable

Conditions

Pediculus Capitis

Interventions

The Lucy ultrasonic comb models A and B combined with the LucyGel

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

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 28, 2016Actual

Primary Completion Date

Jul 26, 2018Actual

Completion Date

Jul 26, 2018Actual

First Submitted Date

Jul 26, 2016

First Submission Date that Met QC Criteria

Jul 31, 2016

First Posted Date

Aug 4, 2016Estimated

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

Mar 27, 2019

Last Update Posted Date

Mar 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

A pilot study to evaluate safety and efficacy of the Lucy combined with LucyGel in killing head lice and their eggs.

23 participants will be enrolled in this study. The first 12 will be combed with model A and the remaining 11 will be combed with model B

Detailed Description

Not provided

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

23Actual

Label	Type	Description	Intervention Names
treatment	Experimental		Device: The Lucy ultrasonic comb models A and B combined with the LucyGel

Name	Type	Description	Arm Group Labels	Other Names
The Lucy ultrasonic comb models A and B combined with the LucyGel	Device		treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events of the device and treatment	measured by AE	up to three days

Secondary Outcomes

Measure	Description	Time Frame
Mortality of up to 70% of the mature head lice 3 hours post treatment		3 hours post treatment
Mortality of up to 50% of the head lice eggs 14 days post treatment.		14 days post treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and Females
Age 6 years and older at the time of enrollment
Must have an active head lice infestation of at least 10live head lice (found within 5 minutes of mechanic search).
Hair must be at least 3 cm long.
Written informed consent - by patient (if over 18 years of age), or by a parent (if patient is under 18 years of age).
For females of childbearing potential, a statement declaring that she is not currently pregnant.

Exclusion Criteria:

Used any chemical head lice treatment in the 7 days preceding the trial treatment
Used antibiotics in the week preceding treatment
Open wounds in the treatment area
Skin irritation in the treatment area
Individuals with skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with treatment or evaluation
Known allergies to any of the gel's components
Participant that is already enrolled in another study
Participant who can't be combed with fine Comb dense ASSY2000

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided