NCT02436291

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 6, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

April 28, 2015

Last Update Submit

May 5, 2015

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

CURE-EX device

EXPERIMENTAL

twice daily treatment with CURE-EX device for 24-30 weeks

Device: CURE-EX device

Interventions

CURE-EX deviceDEVICE

Treatment with CURE-EX device twice daily for 24-30 weeks.

CURE-EX device

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • lunula infected with onychomycosis.
  • Pregnant or breast feeding female.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lev Yasmin Clinic

Netanya, Israel

RECRUITING

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Avner Shemer, MD

    Dermatology Clinic Natanya Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ofer Mazor

CONTACT

972-52-8566789ofmazor@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 6, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 6, 2015

Record last verified: 2015-04

Locations

IL(1)