Evaluation of the Efficacy of CURE-EX Treatment in Onycho... | NCT02436291

Studies
Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis

NCT02436291

Sponsor

MB Mazor Ltd.

Status

Unknown status

Last Update Posted

May 6, 2015Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Onychomycosis

Interventions

CURE-EX device

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

Apr 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 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Apr 28, 2015

First Submission Date that Met QC Criteria

May 5, 2015

First Posted Date

May 6, 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

May 5, 2015

Last Update Posted Date

May 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Open label study to evaluate the efficacy of CURE-EX device in the treatment of onychomycosis.

Detailed Description

Each affected nail will be treated twice daily for 24-30 weeks. Efficacy will be evaluated by measuring the growth of healthy nail.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CURE-EX device	Experimental	twice daily treatment with CURE-EX device for 24-30 weeks	Device: CURE-EX device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CURE-EX device	Device	Treatment with CURE-EX device twice daily for 24-30 weeks.	CURE-EX device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nail cure as measured by measured by length of healthy nail of at least 5 mm	Cure measured by length of healthy nail of at least 5 mm	24-30 weeks
Nail cure as measured by culture and smear	Nail culture and smear	24-30 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects diagnosed with clinical and mycological onychomycosis (by culture and smear).
Subjects did not receive topical antifungal treatment during the 14 days prior to commencing the study.
Subjects did not receive any systemic antifungal treatment during the 3 months prior to the start of the study.

Exclusion Criteria:

lunula infected with onychomycosis.
Pregnant or breast feeding female.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ofer Mazor	Contact	972-52-8566789		ofmazor@gmail.com

Overall Officials

Name	Affiliation	Role
Avner Shemer, MD	Dermatology Clinic Natanya Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lev Yasmin Clinic	Recruiting	Netanya			Israel

Condition Browse Module

MeSH Terms

ID	Term
D014009	Onychomycosis

Ancestor Terms

ID	Term
D014005	Tinea
D003881	Dermatomycoses
D009181	Mycoses
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided