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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02436291
Other study ID # CURE-01
Secondary ID
Status Recruiting
Phase Phase 4
First received April 28, 2015
Last updated May 5, 2015
Start date October 2014
Est. completion date December 2015

Study information

Verified date April 2015
Source MB Mazor Ltd.
Contact Ofer Mazor
Phone 972-52-8566789
Email ofmazor@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Lev Yasmin Clinic Natanya

Sponsors (1)

Lead Sponsor Collaborator
MB Mazor Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary Nail cure as measured by culture and smear Nail culture and smear 24-30 weeks No
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