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Status unknownNCT02436291Updated May 6, 2015

Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis

A Phase 4 interventional study of CURE-EX device in Onychomycosis, sponsored by MB Mazor Ltd.. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-05-06.

Sponsored by MB Mazor Ltd. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Onychomycosis

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03

In context

Onychomycosis

147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.

This study's planned enrollment of 50 is below the median of 56 across 134 interventional studies indexed under Onychomycosis.

Browse Onychomycosis studies →

Lead sponsor

This is the only study on the registry with MB Mazor Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. lunula infected with onychomycosis.
  2. Pregnant or breast feeding female.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    CURE-EX device

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

    Device: CURE-EX device

Interventions

  • DeviceCURE-EX device

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 24-30 weeks

  2. Nail cure as measured by culture and smear

    Nail culture and smear

    Time frame: 24-30 weeks

07

Study locations

1 of 1 sites recruiting
  • Lev Yasmin Clinic
    Natanya, Israel
    • Avner Shemer, MD · Contact · 972-9-8655533
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02436291
Lead sponsor
MB Mazor Ltd.
Responsible party
Sponsor
First posted
May 6, 2015
Start date
Oct 2014
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
May 6, 2015

Study contacts

Ofer Mazor
Contact
ofmazor@gmail.com
972-52-8566789
Avner Shemer, MD
principal investigator · Dermatology Clinic Natanya Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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