Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis

May 5, 2015 updated by: MB Mazor Ltd.
Open label study to evaluate the efficacy of CURE-EX device in the treatment of onychomycosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Natanya, Israel
        • Recruiting
        • Lev Yasmin Clinic
        • Contact:
          • Avner Shemer, MD
          • Phone Number: 972-9-8655533

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. lunula infected with onychomycosis.
  2. Pregnant or breast feeding female.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CURE-EX device
twice daily treatment with CURE-EX device for 24-30 weeks
Device: CURE-EX device
Treatment with CURE-EX device twice daily for 24-30 weeks.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MB Mazor Ltd.

Investigators

  • Principal Investigator: Avner Shemer, MD, Dermatology Clinic Natanya Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CURE-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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