Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis

NCT ID: NCT02436291

Last Updated: 2015-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Onychomycosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CURE-EX device

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

Group Type EXPERIMENTAL

CURE-EX device

Intervention Type DEVICE

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

Interventions

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CURE-EX device

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MB Mazor Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Avner Shemer, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Clinic Natanya Israel

Locations

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Lev Yasmin Clinic

Netanya, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ofer Mazor

Role: CONTACT

972-52-8566789

Facility Contacts

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Avner Shemer, MD

Role: primary

972-9-8655533

Other Identifiers

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CURE-01

Identifier Type: -

Identifier Source: org_study_id

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