Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis

MB Mazor Ltd.50 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Onychomycosis

Interventions

CURE-EX deviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lev Yasmin Clinic

Netanya, Israel

RECRUITING

Outcomes

Primary Outcomes

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

Nail cure as measured by culture and smear

Nail culture and smear

Time frame: 24-30 weeks

Central Contacts

Ofer Mazor

CONTACT

972-52-8566789 ofmazor@gmail.com

Data from ClinicalTrials.gov

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