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Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis

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ClinicalTrials.gov Identifier: NCT02436291
Recruitment Status : Unknown
Verified April 2015 by MB Mazor Ltd..
Recruitment status was:  Recruiting
First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
MB Mazor Ltd.

Study Description
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Brief Summary:
Open label study to evaluate the efficacy of CURE-EX device in the treatment of onychomycosis.

Condition or disease Intervention/treatment Phase
Onychomycosis Device: CURE-EX device Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis
Study Start Date : October 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Nail cure as measured by culture and smear [ Time Frame: 24-30 weeks ]
    Nail culture and smear


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436291


Contacts
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Contact: Ofer Mazor 972-52-8566789 ofmazor@gmail.com

Locations
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Israel
Lev Yasmin Clinic Recruiting
Natanya, Israel
Contact: Avner Shemer, MD    972-9-8655533      
Sponsors and Collaborators
MB Mazor Ltd.
Investigators
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Principal Investigator: Avner Shemer, MD Dermatology Clinic Natanya Israel
More Information
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Responsible Party: MB Mazor Ltd.
ClinicalTrials.gov Identifier: NCT02436291    
Other Study ID Numbers: CURE-01
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
 Infection
Mycoses
Nail Diseases
Skin Diseases